Phases of clinical research

The phases of clinical research are the steps in which scientists do experiments with a health intervention in an attempt to find enough evidence for a process which would be useful as a medical treatment. In the case of pharmaceutical study, the phases start with drug design and drug discovery then proceed on to animal testing. If this is successful, they begin the clinical phase of development by testing for safety in a few human subjects and expand to test in many study participants to determine if the treatment is effective.

Summary

Clinical trials involving new drugs are commonly classified into four phases. Individual trials may encompass more than one phase. A common example of this is combined phase I/II or phase II/III trials. Therefore, it may be easier to think of early phase studies and late phase studies.[1] The drug-development process will normally proceed through all four phases over many years. If the drug successfully passes through Phases I, II, and III, it will usually be approved by the national regulatory authority for use in the general population. Phase IV are 'post-approval' studies.

Summary of clinical trial phases
Phase Primary goal Dose Patient monitor Typical number of participants Success rate[2] Notes
Preclinical Testing of drug in non-human subjects, to gather efficacy, toxicity and pharmacokinetic information unrestricted scientific researcher not applicable (in vitro and in vivo only)
Phase 0 Pharmacokinetics; particularly, oral bioavailability and half-life of the drug very small, subtherapeutic clinical researcher 10 people often skipped for phase I
Phase I Testing of drug on healthy volunteers for dose-ranging often subtherapeutic, but with ascending doses clinical researcher 20–100 normal healthy volunteers (or for cancer drugs, cancer patients) approximately 70% determines whether drug is safe to check for efficacy
Phase II Testing of drug on patients to assess efficacy and side effects therapeutic dose clinical researcher 100–300 patients with specific diseases approximately 33% determines whether drug can have any efficacy; at this point, the drug is not presumed to have any therapeutic effect whatsoever
Phase III Testing of drug on patients to assess efficacy, effectiveness and safety therapeutic dose clinical researcher and personal physician 300–3,000 patients with specific diseases 25–30% determines a drug's therapeutic effect; at this point, the drug is presumed to have some effect
Phase IV Postmarketing surveillance – watching drug use in public therapeutic dose personal physician anyone seeking treatment from their physician N/A watch drug's long-term effects
Pre-clinical studies

Before pharmaceutical companies start clinical trials on a drug, they conduct extensive pre-clinical studies. These involve in vitro (test tube or cell culture) and in vivo (animal) experiments using wide-ranging doses of the study drug to obtain preliminary efficacy, toxicity and pharmacokinetic information. Such tests assist pharmaceutical companies to decide whether a drug candidate has scientific merit for further development as an investigational new drug.

Phase 0

Phase 0 is a recent designation for optional exploratory trials conducted in accordance with the United States Food and Drug Administration's (FDA) 2006 Guidance on Exploratory Investigational New Drug (IND) Studies.[3] Phase 0 trials are also known as human microdosing studies and are designed to speed up the development of promising drugs or imaging agents by establishing very early on whether the drug or agent behaves in human subjects as was expected from preclinical studies. Distinctive features of Phase 0 trials include the administration of single subtherapeutic doses of the study drug to a small number of subjects (10 to 15) to gather preliminary data on the agent's pharmacokinetics (what the body does to the drugs).[4]

A Phase 0 study gives no data on safety or efficacy, being by definition a dose too low to cause any therapeutic effect. Drug development companies carry out Phase 0 studies to rank drug candidates in order to decide which has the best pharmacokinetic parameters in humans to take forward into further development. They enable go/no-go decisions to be based on relevant human models instead of relying on sometimes inconsistent animal data.

Phase I

Phase I trials were formerly referred to as “first-in-man studies” but the field generally moved to the gender-neutral language phrase "first-in-humans" in the 1990s;[5] these trials are the first stage of testing in human subjects.[6] They are designed to test the safety, side effects, best dose, and formulation method for the drug.[7]

Normally, a small group of 2–100 healthy volunteers will be recruited.[2][6] These trials are often conducted in a clinical trial clinic, where the subject can be observed by full-time staff. These clinical trial clinics are often run by contract research organization (CROs) who conduct these studies on behalf of pharmaceutical companies or other research investigators. The subject who receives the drug is usually observed until several half-lives of the drug have passed. This phase is designed to assess the safety (pharmacovigilance), tolerability, pharmacokinetics, and pharmacodynamics of a drug. Phase I trials normally include dose-ranging, also called dose escalation studies, so that the best and safest dose can be found and to discover the point at which a compound is too poisonous to administer.[8] The tested range of doses will usually be a fraction of the dose that caused harm in animal testing. Phase I trials most often include healthy volunteers. However, there are some circumstances when clinical patients are used, such as patients who have terminal cancer or HIV and the treatment is likely to make healthy individuals ill. These studies are usually conducted in tightly controlled clinics called CPUs (Central Pharmacological Units), where participants receive 24-hour medical attention and oversight. In addition to the previously mentioned unhealthy individuals, “patients who have typically already tried and failed to improve on the existing standard therapies"[1] may also participate in phase I trials. Volunteers are paid a variable inconvenience fee for their time spent in the volunteer center.

Before beginning a phase I trial, the sponsor must submit an Investigational New Drug application to the FDA detailing the preliminary data on the drug gathered from cellular models and animal studies.

Phase I trials can be further divided:

Single ascending dose (Phase Ia)
In single ascending dose studies, small groups of subjects are given a single dose of the drug while they are observed and tested for a period of time to confirm safety.[6][9] Typically, a small number of participants, usually three, are entered sequentially at a particular dose.[1] If they do not exhibit any adverse side effects, and the pharmacokinetic data are roughly in line with predicted safe values, the dose is escalated, and a new group of subjects is then given a higher dose. If unacceptable toxicity is observed in any of the three participants, an additional number of participants, usually three, are treated at the same dose.[1] This is continued until pre-calculated pharmacokinetic safety levels are reached, or intolerable side effects start showing up (at which point the drug is said to have reached the maximum tolerated dose (MTD)). If an additional unacceptable toxicity is observed, then the dose escalation is terminated and that dose, or perhaps the previous dose, is declared to be the maximally tolerated dose. This particular design assumes that the maximally tolerated dose occurs when approximately one-third of the participants experience unacceptable toxicity. Variations of this design exist, but most are similar.[1]
Multiple ascending dose (Phase Ib)
Multiple ascending dose studies investigate the pharmacokinetics and pharmacodynamics of multiple doses of the drug, looking at safety and tolerability. In these studies, a group of patients receives multiple low doses of the drug, while samples (of blood, and other fluids) are collected at various time points and analyzed to acquire information on how the drug is processed within the body. The dose is subsequently escalated for further groups, up to a predetermined level.[6][9]
Food effect
A short trial designed to investigate any differences in absorption of the drug by the body, caused by eating before the drug is given. These studies are usually run as a crossover study, with volunteers being given two identical doses of the drug while fasted, and after being fed.
Phase II

Once a dose or range of doses is determined, the next goal is to evaluate whether the drug has any biological activity or effect.[1] Phase II trials are performed on larger groups (100–300) and are designed to assess how well the drug works, as well as to continue Phase I safety assessments in a larger group of volunteers and patients. Genetic testing is common, particularly when there is evidence of variation in metabolic rate.[1] When the development process for a new drug fails, this usually occurs during Phase II trials when the drug is discovered not to work as planned, or to have toxic effects.

Phase II studies are sometimes divided into Phase IIA and Phase IIB. There is no formal definition for these 2 sub-categories, but generally:

  • Phase IIA studies are usually pilot studies designed to demonstrate clinical efficacy or biological activity ('proof of concept' studies);
  • Phase IIB studies look to find the optimum dose at which the drug shows biological activity with minimal side-effects (‘definite dose-finding’ studies).

Some trials combine Phase I and Phase II, and test both efficacy and toxicity.

Trial design
Some Phase II trials are designed as case series, demonstrating a drug's safety and activity in a selected group of patients. Other Phase II trials are designed as randomized controlled trials, where some patients receive the drug/device and others receive placebo/standard treatment. Randomized Phase II trials have far fewer patients than randomized Phase III trials.
Example Cancer Design
In the first stage, the investigator attempts to rule out drugs which have no or little biologic activity. For example, the researcher may specify that a drug must have some minimal level of activity, say, in 20% of participants. If the estimated activity level is less than 20%, the researcher chooses not to consider this drug further, at least not at that maximally tolerated dose. If the estimated activity level exceeds 20%, the researcher will add more participants to get a better estimate of the response rate. A typical study for ruling out a 20% or lower response rate enters 14 participants. If no response is observed in the first 14 participants, the drug is considered not likely to have a 20% or higher activity level. The number of additional participants added depends on the degree of precision desired, but ranges from 10 to 20. Thus, a typical cancer phase II study might include fewer than 30 people to estimate the response rate.[1]
Efficacy vs Effectiveness
When a study assesses efficacy, it is looking at whether the drug given in the specific manner described in the study is able to influence an outcome of interest (e.g. tumor size) in the chosen population (e.g. cancer patients with no other ongoing diseases). When a study is assessing effectiveness, it is determining whether a treatment will influence the disease. In an effectiveness study it is essential that patients are treated as they would be when the treatment is prescribed in actual practice. That would mean that there should be no aspects of the study designed to increase patient compliance above those that would occur in routine clinical practice. The outcomes in effectiveness studies are also more generally applicable than in most efficacy studies (for example does the patient feel better, come to the hospital less or live longer in effectiveness studies as opposed to better test scores or lower cell counts in efficacy studies). There is usually less rigid control of the type of patient to be included in effectiveness studies than in efficacy studies, as the researchers are interested in whether the drug will have a broad effect in the population of patients with the disease.

Some researchers argue that phase II studies are generally smaller than they ought to be.[1]

Success rate

Phase II clinical programs historically have experienced the lowest success rate of the four development phases. In 2010, the percentage of phase II trials that proceeded to phase III was 18%,[10] and only 30.7% of developmental candidates advanced from Phase II to Phase III in a large study of trials from 2006-2015.[11]

Phase III

This phase is designed to assess the effectiveness of the new intervention and, thereby, its value in clinical practice.[1] Phase III studies are randomized controlled multicenter trials on large patient groups (300–3,000 or more depending upon the disease/medical condition studied) and are aimed at being the definitive assessment of how effective the drug is, in comparison with current 'gold standard' treatment. Because of their size and comparatively long duration, Phase III trials are the most expensive, time-consuming and difficult trials to design and run, especially in therapies for chronic medical conditions. Phase III trials of chronic conditions or diseases often have a short follow-up period for evaluation, relative to the period of time the intervention might be used in practice.[1] This is sometimes called the "pre-marketing phase" because it actually measures consumer response to the drug.

It is common practice that certain Phase III trials will continue while the regulatory submission is pending at the appropriate regulatory agency. This allows patients to continue to receive possibly lifesaving drugs until the drug can be obtained by purchase. Other reasons for performing trials at this stage include attempts by the sponsor at "label expansion" (to show the drug works for additional types of patients/diseases beyond the original use for which the drug was approved for marketing), to obtain additional safety data, or to support marketing claims for the drug. Studies in this phase are by some companies categorized as "Phase IIIB studies."[12]

While not required in all cases, it is typically expected that there be at least two successful Phase III trials, demonstrating a drug's safety and efficacy, in order to obtain approval from the appropriate regulatory agencies such as FDA (USA), or the EMA (European Union).

Once a drug has proved satisfactory after Phase III trials, the trial results are usually combined into a large document containing a comprehensive description of the methods and results of human and animal studies, manufacturing procedures, formulation details, and shelf life. This collection of information makes up the "regulatory submission" that is provided for review to the appropriate regulatory authorities[13] in different countries. They will review the submission, and, it is hoped, give the sponsor approval to market the drug.

Most drugs undergoing Phase III clinical trials can be marketed under FDA norms with proper recommendations and guidelines through a New Drug Application (NDA) containing all manufacturing, pre-clinical, and clinical data. In case of any adverse effects being reported anywhere, the drugs need to be recalled immediately from the market. While most pharmaceutical companies refrain from this practice, it is not abnormal to see many drugs undergoing Phase III clinical trials in the market.[14]

Success rate

As of 2010, about 50% of drug candidates either fail during the Phase III trial or are rejected by the national regulatory agency.[15]

Phase II/III cost

The amount of money spent on Phase II/III trials depends on numerous factors, with therapeutic area being studied and types of clinical procedures as key drivers; Phase II studies may cost as much as $20 million, and Phase III as much as $53 million.[16]

Phase IV

A Phase IV trial is also known as postmarketing surveillance trial, or informally as a confirmatory trial. Phase IV trials involve the safety surveillance (pharmacovigilance) and ongoing technical support of a drug after it receives permission to be sold (e.g. after approval under the FDA Accelerated Approval Program).[17] Phase IV studies may be required by regulatory authorities or may be undertaken by the sponsoring company for competitive (finding a new market for the drug) or other reasons (for example, the drug may not have been tested for interactions with other drugs, or on certain population groups such as pregnant women, who are unlikely to subject themselves to trials).[2][6] The safety surveillance is designed to detect any rare or long-term adverse effects over a much larger patient population and longer time period than was possible during the Phase I-III clinical trials.[6][17] Harmful effects discovered by Phase IV trials may result in a drug being no longer sold, or restricted to certain uses; recent examples involve cerivastatin (brand names Baycol and Lipobay), troglitazone (Rezulin) and rofecoxib (Vioxx). The minimum time period mandatory for Phase IV clinical trials is 2 years.

Overall cost

The entire process of developing a drug from preclinical research to marketing can take approximately 12 to 18 years and often costs well over $1 billion.[18][19]

References
  1. DeMets, D., Friedman, L., and Furberg, C. (2010). Fundamentals of Clinical Trials (4th ed.). Springer. ISBN 978-1-4419-1585-6.
  2. "Step 3. Clinical research". US Food and Drug Administration. 14 October 2016. Retrieved 1 February 2017.
  3. CDER (January 2006). "Exploratory IND Studies" (PDF). Guidance for Industry, Investigators, and Reviewers. Food and Drug Administration. Retrieved 2010-06-15.
  4. The Lancet (2009). "Phase 0 trials: a platform for drug development?". Lancet. 374 (9685): 176. doi:10.1016/S0140-6736(09)61309-X. PMID 19616703.
  5. Fisher, JA (1 March 2015). "Feeding and Bleeding: The Institutional Banalization of Risk to Healthy Volunteers in Phase I Pharmaceutical Clinical Trials". Science, technology & human values. 40 (2): 199–226. doi:10.1177/0162243914554838. PMC 4405793Freely accessible. PMID 25914430.
  6. "Phases of clinical trials". Canadian Cancer Society. 2017. Retrieved 1 February 2017.
  7. "NCI Dictionary". National Cancer Institute.
  8. Adil E. Shamoo (2008). "The Myth of Equipoise in Phase 1 Clinical Trials". Medscape J Med. 10 (11): 254. PMC 2605120Freely accessible. PMID 19099004.(registration required)
  9. Elizabeth Norfleet, Shayne Cox Gad, "Phase I Clinical Trials", in Shayne Cox Gad, Clinical Trials Handbook, ISBN 978-0-470-46635-3, 2009, p. 247
  10. "New drugs failing Phase II and III clinical trials". MedCity News.
  11. "Clinical Development Success Rates 2006-2015" (PDF). bio.org. Retrieved 2018-02-11.
  12. "Guidance for Institutional Review Boards and Clinical Investigators". Food and Drug Administration. 1999-03-16. Retrieved 2007-03-27.
  13. The regulatory authority in the USA is the Food and Drug Administration; in Canada, Health Canada; in the European Union, the European Medicines Agency; and in Japan, the Ministry of Health, Labour and Welfare
  14. Arcangelo, Virginia Poole; Andrew M. Peterson (2005). Pharmacotherapeutics for Advanced Practice: A Practical Approach. Lippincott Williams & Wilkins. ISBN 0-7817-5784-3.
  15. Arrowsmith, John (1 February 2011). "Trial watch: Phase III and submission failures: 2007–2010". Nat Rev Drug Discov. 10 (2): 87–87. doi:10.1038/nrd3375 – via www.nature.com.
  16. Sertkaya, A; Wong, H. H.; Jessup, A; Beleche, T (2016). "Key cost drivers of pharmaceutical clinical trials in the United States". Clinical Trials. 13 (2): 117–26. doi:10.1177/1740774515625964. PMID 26908540.
  17. "What Are the Phases of Clinical Trials?". American Cancer Society. 2017. Retrieved 17 July 2017.
  18. Holland, John (2013). "Fixing a broken drug development process". Journal of Commercial Biotechnology. 19. doi:10.5912/jcb588.
  19. Adams, C. P.; Brantner, V. V. (2006). "Estimating the Cost of New Drug Development: Is It Really $802 Million?". Health Affairs. 25 (2): 420–8. doi:10.1377/hlthaff.25.2.420. PMID 16522582.
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Phases of clinical research

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Phases of clinical research

The phases of clinical research are the steps in which scientists do experiments with a health intervention in an attempt to find enough evidence for a process which would be useful as a medical treatment. In the case of pharmaceutical study, the phases start with drug design and drug discovery then proceed on to animal testing. If this is successful, they begin the clinical phase of development by testing for safety in a few human subjects and expand to test in many study participants to determine if the treatment is effective. Summary Clinical trials involving new drugs are commonly classified into four phases. Individual trials may encompass more than one phase. A common example of this is combined phase I/II or phase II/III trials. Therefore, it may be easier to think of early phase studies and late phase studies.[1] The drug-development process will normally proceed through all four phases over many years. If the drug successfully passes through Phases I, II, and III, it will usually be approved by the ...more...

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Clinical research

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Clinical research

Clinical research is a branch of healthcare science that determines the safety and effectiveness (efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. Clinical research is different from clinical practice. In clinical practice established treatments are used, while in clinical research evidence is collected to establish a treatment. Overview The term "clinical research" refers to the entire bibliography of a drug/device/biologic, in fact any test article from its inception in the lab to its introduction to the consumer market and beyond. Once the promising candidate or the molecule is identified in the lab, it is subjected to pre-clinical studies or animal studies where different aspects of the test article (including its safety toxicity if applicable and efficacy, if possible at this early stage) are studied.[1][2][3] In the United States, when a test article is un ...more...

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Pre-clinical development

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Pre-clinical development

In drug development, preclinical development, also named preclinical studies and nonclinical studies, is a stage of research that begins before clinical trials (testing in humans) can begin, and during which important feasibility, iterative testing and drug safety data are collected. The main goals of pre-clinical studies are to determine the safe dose for first-in-man study and assess a product's safety profile. Products may include new medical devices, drugs, gene therapy solutions and diagnostic tools. On average, only one in every 5,000 compounds that enters drug discovery to the stage of preclinical development becomes an approved drug.[1] Types of preclinical research Each class of product may undergo different types of preclinical research. For instance, drugs may undergo pharmacodynamics (what the drug does to the body) (PD), pharmacokinetics (what the body does to the drug) (PK), ADME, and toxicology testing. This data allows researchers to allometrically estimate a safe starting dose of the drug ...more...

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Clinical Trial Info

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Clinical trial

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Clinical trial

Clinical trials are experiments or observations done in clinical research. Such prospective biomedical or behavioral research studies on human participants are designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. Clinical trials generate data on safety and efficacy.[1] They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial – their approval does not mean that the therapy is 'safe' or effective, only that the trial may be conducted. Depending on product type and development stage, investigators initially enroll volunteers or patients into small pilot studies, and subsequently conduct progressively larger scale comparative studie ...more...

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Phase 3

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Phase 3

Phase 3 may refer to: The third of the phases of clinical research Phase 3 Eclipse, an ultralight aircraft Phase 3 of the Marvel Cinematic Universe, slated to begin with the 2016 production Captain America: Civil War Phase 3 may refer to: The third of the phases of clinical research Phase 3 Eclipse, an ultralight aircraft Phase 3 of the Marvel Cinematic Universe, slated to begin with the 2016 production Captain America: Civil War ...more...



Phase 1

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ERT (company)

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ERT (company)

ERT (eResearchTechnology, Inc.) is a global company specializing in clinical services and customizable medical devices to biopharmaceutical and healthcare organizations. It is offers centralized cardiac safety and respiratory efficacy services in drug development and also collects, analyzes and distributes electronic patient-reported outcomes (ePRO) in multiple modalities across all phases of clinical research. History ERT, formerly known as Cardio Data Systems, was founded in 1972 and analyzed ambulatory Holter electrocardiograms and conducted its first research study in 1975. By the end of that year the company expanded into the largest U.S. Holter monitoring research provider of evaluating cardiovascular drugs for approval by the U.S. Food and Drug Administration (FDA). In 1979, the company analyzed 4,500 Holter readings for the National Institutes of Health’s Beta Blocker Heart Attack Trial. The study resulted in the recommendation to use the drug propranolol for at least three years in patients who have ...more...

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Clinical data management

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Clinical data management

Clinical data management (CDM) is a critical phase in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials.[1] Clinical data management assures collection, integration and availability of data at appropriate quality and cost. It also supports the conduct, management and analysis of studies across the spectrum of clinical research as defined by the National Institutes of Health (NIH). The ultimate goal of CDM is to assure that data support conclusions drawn from research. Achieving this goal protects public health and confidence in marketed therapeutics. Role of the clinical data manager in a clinical trial Job profile acceptable in CDM: clinical researcher, clinical research associate, clinical research coordinator etc. The clinical data manager plays a key role in the setup and conduct of a clinical trial. The data collected during a clinical trial forms the basis of subsequent safety and efficacy analysis which in turn drive decision maki ...more...

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Phase 4

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Phase 4

Phase 4 or Four phase may refer to: Phase 4 Films Phase IV, 1974 film The fourth of the phases of clinical research Phase 4 Stereo, record label and recording process Phase 4, a clone of Kasumi and playable character in Dead or Alive 5 Ultimate Four-Phase Systems Four-phase logic Four phase model ...more...



Biomedical Systems

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Biomedical Systems

Biomedical Systems Corporation was a global company specializing in clinical trials services and medical devices to biopharmaceutical and healthcare organizations. Founded in 1975, Biomedical Systems offered centralized cardiac safety, medical imaging and respiratory services in drug development and also collected, analyzed and distributed electronic patient-reported outcome (ePRO)[1] in multiple modalities across all phases of clinical research.[2] On September 8, 2017, ERT announced its acquisition of Biomedical Systems.[3] History In 2010 Biomedical Systems introduced their own Wireless Ambulatory ECG Monitoring System called the TruVue™ Wireless Telemetry Device as part of their Cardiac Patient Services Business. TruVue would record and remotely transmit heartbeats for up to 30 days; and was intended for the diagnosis and management of atrial fibrillation and other cardiac arrhythmia.[4] Biomedical Systems later sold TruVue to Malvern, Pennsylvania-based BioTelemetry, Inc. for $8.65 million.[5] Later i ...more...

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DaVita Clinical Research

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DaVita Clinical Research

DaVita Clinical Research, formerly Total Renal Research, Inc., is a clinical trial company which conducts Phase I and II studies and manages a network of trial sites that operate Phase II-IV clinical trials.[1] It is a wholly owned subsidiary of DaVita, Inc.. It has trial sites in North America and Europe.[2] DaVita Clinical Research works with CROs and manufacturers on clinical trials.[3] History DaVita Clinical Research was founded in 1985 in a hospital-based facility at Hennepin County Medical Center in Minneapolis, MN.[4] In 2012, DaVita Clinical Research partnered with St. Anthony Medical Campus to establish a hospital-based research facility containing 80 beds, which increased the company's trial capacity from 42 to 122 beds in North America.[5][6] DaVita Clinical Research merged with HealthCare Partners Clinical Research, which was acquired by DaVita, Inc. in 2012 for $4.4 billion, in December 2014.[7][4] In August 2016, DaVita Clinical Research announced a global strategic alliance with Quintiles t ...more...



Glossary of clinical research

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Glossary of clinical research

A glossary of terms used in clinical research. A Activities of daily living The tasks of everyday life. These activities include eating, dressing, getting into or out of a bed or chair, taking a bath or shower, and using the toilet. Instrumental activities of daily living are activities related to independent living and include preparing meals, managing money, shopping, doing housework, and using a telephone. Also called ADL. (NCI) Adverse drug reaction In the preapproval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) may not be established, all noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions. The phrase "responses to a medicinal product" means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility, i.e., the relationship cannot be ruled out. Regarding marketed medicinal products: A response to a drug that ...more...

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Multicenter trial

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Multicenter trial

A multicenter research trial is a clinical trial conducted at more than one medical center or clinic. Most large clinical trials, particularly Phase III trials, are conducted at several clinical research centers. Benefits The benefits of multicenter trials include a larger number of participants, different geographic locations, the possibility of inclusion of a wider range of population groups, and the ability to compare results among centers, all of which increase the generalizability of the study. In many cases, efficacy will vary significantly between population groups with different genetic, environmental, and ethnic or cultural backgrounds ("demographic" factors); normally only geographically dispersed trials can properly evaluate this. External links ClinicalTrials.gov from US National Library of Medicine Role of ICH GCP and Recruitment Strategies Training of Clinical Sites Staff in Successful Patient Recruitment Rates By Marithea Goberville, Ph.D. IBPA Publications 2005 ...more...

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Medical research

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Medical research

Cell culture vials. The University of Florida Cancer and Genetics Research Complex is an integrated medical research facility Biomedical research (or experimental medicine) encompasses a wide array of research, extending from "basic research" (also called bench science or bench research),[1] – involving fundamental scientific principles that may apply to a preclinical understanding – to clinical research, which involves studies of people who may be subjects in clinical trials. Within this spectrum is applied research, or translational research, conducted to expand knowledge in the field of medicine. Both clinical and preclinical research phases exist in the pharmaceutical industry's drug development pipelines, where the clinical phase is denoted by the term clinical trial. However, only part of the clinical or preclinical research is oriented towards a specific pharmaceutical purpose. The need for fundamental and mechanism-based understanding, diagnostics, medical devices, and non-pharmaceutical ther ...more...

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Phase II

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Phase II

Phase II may refer to: Phase II, the second of the phases of clinical research Phase II reactions, conjugation reactions in drug metabolism PHASE 2, a graffiti artist in New York City Phase Two, the second group of films in the Marvel Cinematic Universe Star Trek: Phase II, an unrealized television series based on the characters of Gene Roddenberry's Star Trek Star Trek: Phase II (fan series), a fan-created science fiction series set in the Star Trek universe Phase II (Prince Royce album) Phase II Johnny Smith album ...more...



Clinical trials unit

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Clinical trials unit

Clinical trials units (CTU) are specialised biomedical research units which design, centrally coordinate and analyse clinical trials and other studies. Some CTUs specialise in different methodologies, such as randomised controlled trials, cluster randomised trials, surgical trials, and health services research. Some specialise in one disease type, whereas others are generic units. Some CTUs focus on specific phases and types of clinical trials; others conduct all phases and types of trial. United Kingdom The UKCRC evaluates CTUs in the UK and they may be given either Full or Provisional CTU registration status. All Registered CTUs are required to provide evidence that their work is of high quality by demonstrating (1) experience of coordinating multi-centre randomised controlled trials or other well-designed studies, (2) a presence of a core team of expert staff to develop studies, (3) a presence of robust quality assurance systems and processes to meet appropriate regulations and legislation, and (4) eviden ...more...

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Clinical trial management system

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Clinical trial management system

A Clinical Trial Management System (CTMS) is a software system used by biotechnology and pharmaceutical industries to manage clinical trials in clinical research. The system maintains and manages planning, performing and reporting functions, along with participant contact information, tracking deadlines and milestones. Terminology eClinical is a term used within the biopharmaceutical industry to refer to trial automation technology. Originally, "eClinical" was used to refer to any involved technology. Without a more specific definition, the industry used "eClinical" to name technologies such as electronic data capture, clinical trial management systems or Randomization and Trial Supply Management systems, commonly using Interactive voice response systems, electronic patient diaries and other applications. More recently, the term evolved to encompass the entire "business process" instead of individual technologies.[1] An example of an "eClinical solution" is the combination of EDC and IVR systems where commo ...more...

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PAREXEL

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PAREXEL

PAREXEL International is a global provider of biopharmaceutical services. It conducts clinical trials on behalf of its pharmaceutical clients to expedite the drug approval process. It is the second largest clinical research organization in the world and has helped develop approximately 95% of the 200 top-selling biopharmaceuticals on the market today.[2] The company publishes the annual PAREXEL R&D Statistical Sourcebook,[3] operates the PAREXEL-Academy,[4] and councils all of the top 50 biopharmaceutical and top 30 biotechnology companies.[5] PAREXEL was founded in 1982 by Josef von Rickenbach[6] and organic chemist Anne B. Sayigh[7] initially to advise Japanese and German firms on how to navigate the FDA approval process.[8] The firm has grown organically over the years and through 40 acquisitions. Josef von Rickenbach is credited with establishing PAREXEL’s culture and practices based on the principles he experienced as a researcher at Schering-Plough in Lucerne, Switzerland.[8] In 1990, the firm ex ...more...

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Herpes simplex research

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Herpes simplex research

Herpes simplex research includes all medical research that attempts to prevent, treat, or cure herpes, as well as fundamental research about the nature of herpes. Examples of particular herpes research include drug development, vaccines and genome editing. HSV-1 and HSV-2 are commonly thought of as oral and genital herpes respectively, but other members in the herpes family include chickenpox (varicella/zoster), cytomegalovirus (CMV), and Epstein-Barr (EBV). Vaccine research Various vaccine candidates have been developed, the first ones in the 1920s, but none has been successful to date.[1] Due to the genetic similarity of both herpes simplex virus types (HSV-1 and HSV-2), the development of a prophylactic-therapeutic vaccine that proves effective against one type of the virus would likely prove effective for the other virus type, or at least provide most of the necessary fundamentals. As of 2016, several vaccine candidates are in different stages of clinical trials. An ideal herpes vaccine should induce i ...more...

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Monitoring in clinical trials

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Monitoring in clinical trials

Clinical monitoring is the oversight and administrative efforts that monitor a participant's health and efficacy of the treatment during a clinical trial. Both independent and government-run grant-funding agencies, such as the National Institutes of Health (NIH)[1] and the World Health Organization (WHO)[2], require data and safety monitoring protocols for Phase I and II clinical trials conforming to their standards[3]. Aspects of monitoring According to the U.S. Food and Drug Administration's Center of Drug Evaluation and Research, the top five deficiency categories for site inspections caught by clinical monitors as reported in the 2001 Report to the Nation[4] are: Failure to follow investigation protocol (the procedures and treatment subjects must undergo, as well as the schedule of assessments) Failure to keep adequate and accurate records Problems with the informed consent form Failure to report adverse events Failure to account for the disposition of study drugs Therefore, the primary goal of c ...more...

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National Institutes of Health Clinical Center

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National Institutes of Health Clinical Center

The National Institutes of Health (NIH) Clinical Center is a hospital solely dedicated to clinical research at the NIH campus in Bethesda, Maryland. The Clinical Center, known as Building 10, consists of the original part of the hospital, the Warren Grant Magnuson Clinical Center, and the newest addition, the Mark O. Hatfield Clinical Research Center. The two parts are connected to form one large building.[1] Since the hospital’s opening in 1953,[2] NIH scientists have worked with volunteer patients to create medical innovations. Clinical Center successes include pioneering the cure of cancerous solid tumors with chemotherapy; the use of nitroglycerin to treat heart attacks; identifying a genetic component in schizophrenia; conducting the first successful replacement of a mitral valve to treat heart disease; and the creation of blood tests to identify both Acquired Immune Deficiency Syndrome (AIDS) and hepatitis.[3] In October 2014, Clinical Center staff successfully treated one of the first few Ebola virus ...more...

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Electronic data capture

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Electronic data capture

An electronic data capture (EDC) system is a computerized system designed for the collection of clinical data in electronic format for use mainly in human clinical trials.[1] EDC replaces the traditional paper-based data collection methodology to streamline data collection and expedite the time to market for drugs and medical devices. EDC solutions are widely adopted by pharmaceutical companies and clinical research organizations (CRO). Typically, EDC systems provide: a graphical user interface component for data entry a validation component to check user data a reporting tool for analysis of the collected data EDC systems are used by life sciences organizations, broadly defined as the pharmaceutical, medical device and biotechnology industries in all aspects of clinical research,[2] but are particularly beneficial for late-phase (phase III-IV) studies and pharmacovigilance and post-market safety surveillance. EDC can increase the data accuracy and decrease the time to collect data for studies of drug ...more...

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Translational research

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Translational research

Translational research – often used interchangeably with translational medicine or translational science or bench to bedside – is an effort to build on basic scientific research to create new therapies,[1] medical procedures, or diagnostics. Basic biomedical research is based on studies of diseases processes using for example cell cultures or animal models.[2] The term translational refers to the "translation" of basic scientific findings in a laboratory setting into potential treatments for disease.[3][4][5][6] Definitions Translational research is defined by the European Society for Translational Medicine (EUSTM) as an interdisciplinary branch of the biomedical field supported by three main pillars: bench-side, bedside and community.[2] It is defined for school-based education by the Education Futures Collaboration (www.meshguides.org) as research which translates concepts to classroom practice.[7] Examples of translational research are commonly found in education subject association journals and in the M ...more...

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Outline of clinical research

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Outline of clinical research

The following outline is provided as an overview of and topical guide to clinical research: Clinical research is the aspect of biomedical research that addresses the assessment of new pharmaceutical and biological drugs, medical devices and vaccines in humans. General topics Clinical significance – a conclusion that an intervention has an effect that is of practical meaning to patients Drug discovery – the identification of candidates, synthesis, characterization, screening, and assays for therapeutic efficacy Drug development – the process of taking a new chemical through the stages necessary to allow testing in clinical trials Biotechnology – the technological application that uses biological systems, living organisms to make or modify products or processes for specific use Biopharmaceutical – a drug produced using biotechnology Clinical trial – an experiment with human subjects to assess safety and efficacy of drugs Academic clinical trials – clinical trials run at academic centers (e.g. ...more...

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New Drug Application

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New Drug Application

A new drug application in the 1930s for sulfapyridine to the United States Food and Drug Administration The Food and Drug Administration's New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing.[1][2] Some 30% or less of initial drug candidates proceed through the entire multi-year process of drug development, concluding with an approved NDA, if successful.[1] The goals of the NDA are to provide enough information to permit FDA reviewers to establish the complete history of the candidate drug. Among facts needed for the application are:[2] Patent and manufacturing information Drug safety and specific effectiveness for its proposed use(s) when used as directed Reports on the design, compliance, and conclusions of completed clinical trials by the Institutional Review Board Drug susceptibility to abuse Proposed labeling (package insert) and directions for use Exceptions to this pro ...more...

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Good clinical data management practice

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Good clinical data management practice

Good clinical data management practice (GCDMP) is the current industry standards for clinical data management that consist of best business practice and acceptable regulatory standards. In all phases of clinical trials, clinical and laboratory information must be collected and converted to digital form for analysis and reporting purposes. The U.S. Food and Drug Administration and International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use have provided specific regulations and guidelines surrounding this component of the drug and device development process. The effective, efficient and regulatory-compliant management of clinical trial data is an essential component of drug and device development. The Society for Clinical Data Management (SCDM) has created a comprehensive document that provides guidance on accepted practices of clinical data management (CDM) that are not totally covered by current guidelines and regulations. This document is entitled G ...more...

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Parkinson's disease clinical research

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Parkinson's disease clinical research

Parkinson's disease clinical research (also known as clinical trials, medical research, research studies, or clinical studies) is any study intended to help answer questions about etiology, diagnostic approaches or new treatments by studying their effects on human subjects. Clinical trials are designed and conducted by scientists and medical experts, who invite participants to undergo testing new vaccines, therapies, or treatments.[1] Only a small fraction of patients with Parkinson's disease (PD) participate in clinical research and specially in clinical trials. When clinical trials lack participation, it causes a significant delay in the development of new drugs and treatments.[2] Research directions One of the purposes of clinical research is to test the safety and efficacy of new treatments. Clinical research may also be conducted to learn other things about medical treatments or procedures, such as how to make an earlier diagnosis or how the treatment interacts with other drugs. Though there are many ...more...

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Drug development

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Drug development

Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery. It includes pre-clinical research on microorganisms and animals, filing for regulatory status, such as via the United States Food and Drug Administration for an investigational new drug to initiate clinical trials on humans, and may include the step of obtaining regulatory approval with a new drug application to market the drug.[1][2] New chemical entity development Broadly, the process of drug development can be divided into pre-clinical and clinical work. Timeline showing the various drug approval tracks and research phases Pre-clinical New chemical entities (NCEs, also known as new molecular entities or NMEs) are compounds that emerge from the process of drug discovery. These have promising activity against a particular biological target that is important in disease. However, little is known about the safety, toxicity, pharmacokinetics ...more...

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Histone deacetylase inhibitor

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Histone deacetylase inhibitor

Histone deacetylase inhibitors (HDAC inhibitors, HDACi, HDIs) are chemical compounds that inhibit histone deacetylase. HDIs have a long history of use in psychiatry and neurology as mood stabilizers and anti-epileptics. More recently they are being investigated as possible treatments for cancers,[1][2] parasitic[3] and inflammatory diseases.[4] Cellular biochemistry/pharmacology To carry out gene expression, a cell must control the coiling and uncoiling of DNA around histones. This is accomplished with the assistance of histone acetyl transferases (HAT), which acetylate the lysine residues in core histones leading to a less compact and more transcriptionally active chromatin, and, on the converse, the actions of histone deacetylases (HDAC), which remove the acetyl groups from the lysine residues leading to the formation of a condensed and transcriptionally silenced chromatin. Reversible modification of the terminal tails of core histones constitutes the major epigenetic mechanism for remodeling higher-order ...more...

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HIV vaccine

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HIV vaccine

Various approaches for HIV vaccine development An HIV vaccine is a vaccine which would either protect individuals who do not have HIV from contracting that virus, or otherwise may have a therapeutic effect for persons who have or later contract HIV/AIDS. Currently, there is no effective HIV vaccine but many research projects managing clinical trials seek to create one. There is evidence that a vaccine may be possible. Preventative medications such as antiretroviral treatments have been put into use to help prevent infection, but do not work as well as a vaccine would.[1] Work with monoclonal antibodies (MAb) has shown or proven that the human body can defend itself against HIV, and certain individuals remain asymptomatic for decades after HIV infection. Potential candidates for antibodies and early stage results from clinical trials have been announced. One HIV vaccine candidate which showed some efficacy was studied in RV 144, which was a trial in Thailand beginning in 2003 and first reporting a positive ...more...

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Pharmacovigilance

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Pharmacovigilance

Pharmacovigilance (PV or PhV), also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.[1] The etymological roots for the word "pharmacovigilance" are: pharmakon (Greek for drug) and vigilare (Latin for to keep watch). As such, pharmacovigilance heavily focuses on adverse drug reactions, or ADRs, which are defined as any response to a drug which is noxious and unintended, including lack of efficacy (the condition that this definition only applies with the doses normally used for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological disorder function was excluded with the latest amendment of the applicable legislation[2]). Medication errors such as overdose, and misuse and abuse of a drug as well as drug exposure during pregnancy and breastfeeding, are also of interest, even without an adverse event, because they may result in an adverse drug react ...more...

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Rule of three (statistics)

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Rule of three (statistics)

Comparison of the rule of three to the exact binomial one-sided confidence interval with no positive samples In statistical analysis, the rule of three states that if a certain event did not occur in a sample with n subjects, the interval from 0 to 3/n is a 95% confidence interval for the rate of occurrences in the population. When n is greater than 30, this is a good approximation of results from more sensitive tests. For example, a pain-relief drug is tested on 1500 human subjects, and no adverse event is recorded. From the rule of three, it can be concluded with 95% confidence that fewer than 1 person in 500 (or 3/1500) will experience an adverse event. By symmetry, one could expect for only successes, the 95% confidence interval is [1−3/n,1]. The rule is useful in the interpretation of clinical trials generally, particularly in phase II and phase III where often there are limitations in duration or statistical power. The rule of three applies well beyond medical research, to any trial done n times. If ...more...

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Proof of concept

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Proof of concept

Proof of concept (PoC) is a realization of a certain method or idea in order to demonstrate its feasibility,[1] or a demonstration in principle with the aim of verifying that some concept or theory has practical potential. A proof of concept is usually small and may or may not be complete. Usage history The appearance of the term in news archives suggests it might have been in common use as early as 1967.[2] In 1969 Committee on Science and Astronautics. Subcommittee on Advanced Research and Technology hearing proof of concept was defined as following "The Board defined proof of concept as a phase in development in which experimental hardware is constructed and tested to explore and demonstrate the feasibility of a new concept".[3] One of the early definitions of the term "proof of concept" was by Bruce Carsten in the context of a "proof-of-concept prototype" in the column "Carsten's Corner": Proof-of-Concept Prototype is a term that (I believe) I coined in 1984. It was used to designate a circuit constru ...more...

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Investigational New Drug

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Investigational New Drug

The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved. The FDA reviews the IND application for safety to assure that research subjects will not be subjected to unreasonable risk. If the application is cleared, the candidate drug usually enters a Phase 1 clinical trial. Regulations are primarily at 21 C.F.R. 312. Criteria for application An IND is required for a clinical study if it is intended to support a: New indication Change in the approved route of administration or dosage level Change in the approved patient population (e.g. pediatric) or a population at greater or increase of risk (elderly, HIV positive, immunocompromised) Significant change in the promotion of an approved drug Application contents The IND application must contain information in three b ...more...

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Cost of drug development

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Cost of drug development

The cost of drug development is the full cost of bringing a new drug (i.e., new chemical entity) to market from drug discovery through clinical trials to approval. Typically, companies spend tens to hundreds of millions of U.S. dollars.[1] One element of the complexity is that the much-publicized final numbers often not only include the out-of-pocket expenses for conducting a series of Phase I-III clinical trials, but also the capital costs of the long period (10 or more years) during which the company must cover out-of-pocket costs for preclinical drug discovery. Additionally, companies often do not report whether a given figure includes the capitalized cost or comprises only out-of-pocket expenses, or both. Another element of complexity is that all estimates are based on confidential information controlled by drug companies, released by them voluntarily, leading to inability to verify costs. The numbers are controversial, as drug companies use them to justify the prices of their drugs and various advocates ...more...

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List of phase III cancer clinical trials, 2015

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List of phase III cancer clinical trials, 2015

compound cancer type reference companies involved Abemaciclib breast cancer, lung cancer Atezolizumab bladder cancer Genentech, Roche Alectinib lung cancer Ruxolitinib pancreatic cancer Avelumab non-small-cell lung cancer RHB-104 gastrointestinal cancer RedHill Biopharma Vicinium bladder cancer Viventia Cetuximab colorectal cancer eltrapuldencel-T melanoma Caladrius Biosciences Panitumumab colorectal cancer Olaratumab sarcoma Pertuzumab breast cancer Genentech AGS-003 renal cell carcinoma Argos Therapeutics[1] Rociletinib non-small-cell lung cancer Niraparib ovarian cancer Sunitinib small-cell lung cancer Pazopanib ovarian cancer nelipepimut-s breast cancer Xilonix colorectal cancer Cabozantinib prostate cancer Bevacizumab lung cancer Rucaparib ovarian cancer Clovis Oncology Ganetespib lung cancer Copanlisib non-Hodgkin lymphoma Palbociclib breast cancer Selumetinib melanoma Nivolumab lung cancer Rigos ...more...

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Zika virus vaccine

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Zika virus vaccine

A Zika virus vaccine is designed to prevent the symptoms and complications of Zika virus infection in humans. As Zika virus infection of pregnant women may result in congenital defects in the newborn, the vaccine will attempt to protect against congenital Zika syndrome during the current or any future outbreak.[1] As of May 2017, no vaccines has been approved for clinical use, however a number of vaccines are currently in clinical trials.[2][3] The goal of a Zika virus vaccine is to elicit protective antibodies against the Zika virus to prevent infection and severe disease. The challenges in developing a safe and effective vaccine include limiting side effects such as Guillain-Barré syndrome, a potential consequence of Zika virus infection. Additionally, as dengue virus is closely related to Zika virus, the vaccine needs to minimize the possibility of antibody-dependent enhancement of dengue virus infection.[4][5][6] DNA Vaccine As of March 31, 2017 a DNA vaccine has been approved for Phase 2 clinical trials ...more...

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Clinical trials registry

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Clinical trials registry

A clinical trials registry is an official platform and catalog for registering a clinical trial. Some countries require clinical trials being conducted in that country to be registered; others do not require it, but often strongly encourage it. ClinicalTrials.gov, run by the United States National Library of Medicine (NLM) was the first online registry for clinical trials and is the largest and most widely used today. Clinical trials are conducted to allow safety and efficacy data to be collected for health interventions (e.g., drugs, diagnostics, devices, therapy protocols). The goal of a clinical trials registry is to provide increased transparency and access to clinical trials, made available to the public. Clinical trials registries are often searchable (for example, trials can be searchable by disease/indication, drug, location, etc.). Trials are registered by the pharmaceutical, biotech or medical device company (Sponsor) or by the hospital or foundation which is sponsoring the study, or by another org ...more...

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Malaria vaccine

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Malaria vaccine

Malaria vaccine is a vaccine that is used to prevent malaria. The only approved vaccine as of 2015 is RTS,S. It requires four injections, and has a relatively low efficacy (26–50%). Due to low efficacy, WHO does not recommend the use of RTS,S vaccine in babies between 6 and 12 weeks of age.[1] The vaccine is going to be studied further in Africa in 2018.[2] Research continues into recombinant protein and attenuated whole organism vaccines. Approved vaccinesRTS,S RTS,S (developed by PATH Malaria Vaccine Initiative (MVI) and GlaxoSmithKline (GSK) with support from the Bill and Melinda Gates Foundation) is the most recently developed recombinant vaccine. It consists of the P. falciparum circumsporozoite protein (CSP) from the pre-erythrocytic stage. The CSP antigen causes the production of antibodies capable of preventing the invasion of hepatocytes and additionally elicits a cellular response enabling the destruction of infected hepatocytes. The CSP vaccine presented problems in trials due to its poor immunog ...more...

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IQVIA

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IQVIA

IQVIA, formerly Quintiles IMS Holdings, Inc.,[2] is an American multinational company serving the combined industries of health information technologies and clinical research. It is a provider of biopharmaceutical development and commercial outsourcing services, focused primarily on Phase I-IV clinical trials and associated laboratory and analytical services, including consulting services. They have a network of more than 50,000 employees in approximately 100 countries.[2] As of 2017, IQVIA was reported to be one of the world’s largest contract research organizations.[3] History In 1982, Dennis Gillings founded and incorporated Quintiles Transnational in North Carolina.[4] Quintiles Transnational established Quintiles Pacific Inc. and Quintiles Ireland Ltd. in 1990,[5] and in 1991 Quintiles GmbH was established in Germany and Quintiles Laboratories Ltd. was established in Atlanta, Georgia.[6] In September 1996, Quintiles purchased Innovex Ltd. of Britain for $747.5 million in stock.[7] Quintiles went ...more...

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Randomized controlled trial

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Randomized controlled trial

Flowchart of four phases (enrollment, intervention allocation, follow-up, and data analysis) of a parallel randomized trial of two groups, modified from the CONSORT (Consolidated Standards of Reporting Trials) 2010 Statement[1] A randomized controlled trial (or randomized control trial;[2] RCT) is a type of scientific (often medical) experiment which aims to reduce bias when testing a new treatment. The people participating in the trial are randomly allocated to either the group receiving the treatment under investigation or to a group receiving standard treatment (or placebo treatment) as the control. Randomization minimises selection bias and the different comparison groups allow the researchers to determine any effects of the treatment when compared with the no treatment (control) group, while other variables are kept constant. The RCT is often considered the gold standard for a clinical trial. RCTs are often used to test the efficacy or effectiveness of various types of medical intervention and may pro ...more...

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International Clinical Research Center

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International Clinical Research Center

International Clinical Research Center of St. Anne's University Hospital Brno (FNUSA-ICRC) is a new generation science and research center. It focuses on finding new methods, technologies and medicaments for prevention, diagnostics and treatment of cardiovascular and neurological diseases, particularly heart failure, coronary heart disease, hypertension, cardiac arrhythmias, obesity, structural heart diseases, sleep apnea, stroke, and dementia. The center located in Brno, Czech Republic, is based on the collaboration with a number of foreign (such as Mayo Clinic, University College London, University of Minnesota etc.) and Czech (such as Masaryk University, Brno University of Technology, Academy of Sciences etc.) academic institutions and industrial companies. At present, the number of employees is more than 400, including approximately 350 specialists working in 17 international research teams. History May 2013 - New FNUSA-ICRC Chair Gorazd B. Stokin, M.D., MSc., Ph.D. This Slovenian native won the recru ...more...

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Washout

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Washout

Look up washout in Wiktionary, the free dictionary. Washout may refer to: Washout (erosion), the erosion of a soft surface by a gush of water Washout (aeronautics), the practice of building a wing with a twist from root to tip Washout (comics), a mutant character in the Marvel Comics universe "Washout", a song by The Fallout Trust "Washout", a 1991 episode of the PBS show Shining Time Station "Washout", a story from The Railway Series book "Thomas Goes Home" Washed Out, the stage name of chillwave musician Ernest Greene The well drilling process for enlarging a drill hole in an oil well A term for a sporting event cancelled due to rain; see Rainout (sports) An alternate name for a Run-in period, a common phase in clinical research Radiocontrast washout, where radiocontrast disappears from a tissue ...more...

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Therapeutic misconception

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Therapeutic misconception

Therapeutic misconception is a common ethical problem encountered in human subjects research. It was originally described in 1982 by Paul Appelbaum and colleagues.[1] The idea was introduced to the bioethics community in 1987.[2] The formulation given by Appelbaum et al. in 1987 was the following: “To maintain a therapeutic misconception is to deny the possibility that there may be major disadvantages to participating in clinical research that stem from the nature of the research process itself.”[3] Context and definitions Therapeutic misconception did not receive great attention until the early 2000s, when references to the concept expanded significantly.[4] Originally only used in the context of randomized controlled trials, the term is now commonly used among sociologists, neuroscientists, and clinical investigators. Therapeutic misconception Therapeutic misconception is detrimental to a subject’s understanding of a study, which is crucial for an autonomous decision.[1][2] Certain factors can increase th ...more...

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Single-subject design

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Single-subject design

In design of experiments, single-subject design or single-case research design is a research design most often used in applied fields of psychology, education, and human behavior in which the subject serves as his/her own control, rather than using another individual/group. Researchers use single-subject design because these designs are sensitive to individual organism differences vs group designs which are sensitive to averages of groups. Often there will be large numbers of subjects in a research study using single-subject design, however—because the subject serves as their own control, this is still a single-subject design.[1] These designs are used primarily to evaluate the effect of a variety of interventions in applied research.[2] Requirements The following are requirements of single-subject designs:[3] Continuous assessment: The behavior of the individual is observed repeatedly over the course of the intervention. This ensures that any treatment effects are observed long enough to convince the sci ...more...

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BCG vaccine

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BCG vaccine

Bacillus Calmette–Guérin (BCG) vaccine is a vaccine primarily used against tuberculosis (TB).[1] In countries where tuberculosis or leprosy is common, one dose is recommended in healthy babies as close to the time of birth as possible.[1] In areas where tuberculosis is not common, only children at high risk are typically immunized, while suspected cases of tuberculosis are individually tested for and treated.[1] Adults who do not have tuberculosis and have not been previously immunized but are frequently exposed may be immunized as well.[1] BCG also has some effectiveness against Buruli ulcer infection and other nontuberculous mycobacteria infections.[1] Additionally it is also often used as part of the treatment of bladder cancer.[2] Rates of protection against tuberculosis infection vary widely and protection lasts up to twenty years.[1] Among children it prevents about 20% from getting infected and among those who do get infected it protects half from developing disease.[3] The vaccine is given by injecti ...more...

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Postmarketing surveillance

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Postmarketing surveillance

Postmarketing surveillance (PMS) (also post market surveillance) is the practice of monitoring the safety of a pharmaceutical drug or medical device after it has been released on the market and is an important part of the science of pharmacovigilance. Since drugs and medical devices are approved on the basis of clinical trials, which involve relatively small numbers of people who have been selected for this purpose – meaning that they normally do not have other medical conditions which may exist in the general population – postmarketing surveillance can further refine, or confirm or deny, the safety of a drug or device after it is used in the general population by large numbers of people who have a wide variety of medical conditions. [1] Postmarketing surveillance uses a number of approaches to monitor drug and device safety, including spontaneous reporting databases, prescription event monitoring, electronic health records, patient registries, and record linkage between health databases.[1] These data are r ...more...

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Patient recruitment

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Patient recruitment

Patient recruitment includes a variety of services—typically performed by a Patient Recruitment Service Provider—to increase enrollment into clinical trials. Presently, the patient recruitment industry is claimed to total $5.9 billion per year.[1] Patient enrollment is the most time-consuming aspect of the clinical trial process. The leading cause of missed clinical trial deadlines is patient recruitment, taking up to 30 percent of the clinical timeline.[2] Improving patient recruitment rates offers pharmaceutical and medical device companies one of the biggest opportunities to accelerate the pace of clinical trials – making it possible to reduce time to market. As the number of patients needed for clinical trials rises – as safety and regulatory issues drive trends toward larger and longer trials – the demand for patient recruitment services grows. Clinical trials are conducted to collect data regarding the safety and efficacy of new drug and device development. They are conducted in a series of phases, ea ...more...

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List of phase III cancer clinical trials 2014

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List of phase III cancer clinical trials 2014

compound cancer type reference companies involved Imprime colorectal cancer Lonsurf (trifluridine and tipiracil hydrochloride) colorectal cancer Taiho Pharmaceuticals Obinutuzumab chronic lymphocytic leukemia Roche Galeterone prostate cancer Tokai Pharmaceuticals momelotinib myelofibrosis anastrozole breast cancer sapacitabine acute myeloid leukaemia everolimus breast cancer lenalidomide blood cancer Celgene asparaginase erythrocyte encapsulated Acute lymphoblastic leukemia Binimetinib melanoma ruxolitinib pancreatic cancer rindopepimut glioblastoma brentuximab Hodgkin's lymphoma crizotinib non-small-cell lung carcinoma Multikine head and neck cancer CEL-SCI Corporation AZD9291 Non-small-cell lung carcinoma AURA2, AURA3 Astrazeneca panobinostat myeloma Novartis Algenpantucel-L pancreatic cancer IMPRESS NewLink pharmaceuticals Livatag hepatocellular carcinoma Onxeo bavituximab non-small cell lung cancer SUNRISE trial Bristol-Myers Squibb ...more...

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Patient-reported outcome

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Patient-reported outcome

A patient-reported outcome (PRO) is a health outcome directly reported by the patient who experienced it. It stands in contrast to an outcome reported by someone else, such as a physician-reported outcome, a nurse-reported outcome, and so on. PRO methods, such as questionnaires, are used in clinical trials or other clinical settings, to help better understand a treatment's efficacy. The use of digitized PROs, or electronic patient-reported outcomes (ePROs), is on the rise in today's health research industry. Terminology PROs should not be confused with PCOs, or patient-centered outcomes. The latter implies the use of a questionnaire covering issues and concerns that are specific to a patient. Instead, patient-reported outcomes refers to reporting situations in which only the patient provides information related to a specific treatment or condition; this information may or may not be of concern to the patient. Further, PROs should not be confused with PREMs (patient reported experience measures), which focus ...more...

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