Clinical trial

clinical trialsclinical studiesclinical studyclinicalPhase IPhase IIItrialsphase IIclinical researchclinical research trials
Clinical trials are experiments or observations done in clinical research.wikipedia
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Human subject research

human experimentationhuman experimentsguinea pig
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.
(A specific, and especially heavily regulated, type of medical human subject research is the "clinical trial", in which drugs, vaccines and medical devices are evaluated.) On the other hand, human subject research in the social sciences often involves surveys which consist of questions to a particular group of people.

Clinical study design

study designstudy designsepidemiologic research design
Clinical study design aims to ensure the scientific validity and reproducibility of the results.
Clinical study design is the formulation of trials and experiments, as well as observational studies in medical, clinical and other types of research (e.g., epidemiological) involving human beings.

Therapy

therapeutictherapisttreatment
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.
Its priority over other options is usually either: (1) formally recommended on the basis of clinical trial evidence for its best-available combination of efficacy, safety, and tolerability or (2) chosen based on the clinical experience of the physician.

Experiment

experimentalexperimentationexperiments
Clinical trials are experiments or observations done in clinical research.
When used, however, experiments typically follow the form of the clinical trial, where experimental units (usually individual human beings) are randomly assigned to a treatment or control condition where one or more outcomes are assessed.

Contract research organization

contract research organizationscontract research organisationClinical research organization
Certain functions necessary to the trial, such as monitoring and lab work, may be managed by an outsourced partner, such as a contract research organization or a central laboratory.
A CRO may provide such services as biopharmaceutical development, biologic assay development, commercialization, preclinical research, clinical research, clinical trials management, and pharmacovigilance.

Multicenter trial

multicentermultiple centersmulti-center studies
Clinical trials can vary in size and cost, and they can involve a single research center or multiple centers, in one country or in multiple countries.
A multicenter research trial is a clinical trial conducted at more than one medical center or clinic.

James Lind

LindLind, James
The first proper clinical trial was conducted by the physician James Lind.
By conducting one of the first ever clinical trials, he developed the theory that citrus fruits cured scurvy.

Pharmaceutical industry

pharmaceutical companypharmaceuticalpharmaceutical companies
The sponsor may be a governmental organization or a pharmaceutical, biotechnology or medical device company.
Animal trials showed very good inhibitory effect as in clinical trials, however a long term study in dogs found toxic effects at higher doses and as a result mevastatin was believed to be too toxic for human use.

Clinical research

clinicalclinical scienceclinical studies
Clinical trials are experiments or observations done in clinical research.
Clinical research management is often aided by eClinical systems to help automate the management and conducting of clinical trials.

Placebo

placebo effectplacebosplacebo studies
While most clinical trials test one alternative to the novel intervention, some expand to three or four and may include a placebo.
In a clinical trial any change in the placebo arm is known as the placebo response, and the difference between this and the result of no treatment is the placebo effect.

Protocol (science)

protocolClinical trial protocolprotocols
Except for small, single-location trials, the design and objectives are specified in a document called a clinical trial protocol.
In a clinical trial, the protocol is carefully designed to safeguard the health of the participants as well as answer specific research questions.

Approved drug

approveddrugsapproved drugs
Only 10 percent of all drugs started in human clinical trials become approved drugs.
Only 10% of all drugs started in human clinical trials become an approved drug.

Austin Bradford Hill

Bradford HillHill, Austin BradfordSir Austin Bradford Hill
The methodology of clinical trials was further developed by Sir Austin Bradford Hill, who had been involved in the streptomycin trials.
Sir Austin Bradford Hill (8 July 1897 – 18 April 1991) was an English epidemiologist and statistician, pioneered the randomized clinical trial and, together with Richard Doll, demonstrated the connection between cigarette smoking and lung cancer.

Medication

pharmaceuticalpharmaceuticalspharmaceutical drug
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. The most common clinical trials evaluate new pharmaceutical products, medical devices (such as a new catheter), biologics, psychological therapies, or other interventions.
Once a compound that fulfills all of these requirements has been identified, it will begin the process of drug development prior to clinical trials.

Epidemiology

epidemiologistepidemiologicalepidemiologists
Types of observational studies in epidemiology, such as the cohort study and the case-control study, provide less compelling evidence than the randomized controlled trial.
Major areas of epidemiological study include disease causation, transmission, outbreak investigation, disease surveillance, environmental epidemiology, forensic epidemiology, occupational epidemiology, screening, biomonitoring, and comparisons of treatment effects such as in clinical trials.

Drug development

developmentdevelopedclinical development
The drug development process will normally proceed through phases I-IV over many years, frequently involving a decade or longer.
It includes preclinical 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.

Informed consent

consentPrior Informed Consentconsensual
Clinical trials recruit study subjects to sign a document representing their "informed consent".
A health care provider may ask a patient to consent to receive therapy before providing it, or a clinical researcher may ask a research participant before enrolling that person into a clinical trial.

Adaptive clinical trial

adaptive clinical trial design.adaptive trial designtrial adaptations
An adaptive clinical trial is a clinical trial that evaluates a medical device or treatment by observing participant outcomes (and possibly other measures, such as side-effects) on a prescribed schedule, and modifying parameters of the trial protocol in accord with those observations.

Randomized controlled trial

randomized controlled trialsrandomized clinical trialrandomized control trial
A fundamental distinction in evidence-based practice is between observational studies and randomized controlled trials.
A well-blinded RCT is often considered the gold standard for clinical trials.

Site management organization

SMO
Specialist site management organizations can also be hired to coordinate with the CRO to ensure rapid IRB/IEC approval and faster site initiation and patient recruitment.
A Site Management Organization (SMO) is an organization that provides clinical trial related services to a contract research organization (CRO), a pharmaceutical company, a biotechnology company, a medical device company or a clinical site.

Randomized experiment

randomized trialrandomizationrandomized
Among his major ideas, was the importance of randomization – the random assignment of individuals to different groups for the experiment; replication – to reduce uncertainty, measurements should be repeated and experiments replicated to identify sources of variation; blocking – to arrange experimental units into groups of units that are similar to each other, and thus reducing irrelevant sources of variation; use of factorial experiments – efficient at evaluating the effects and possible interactions of several independent factors.
Randomization of treatment in clinical trials pose ethical problems.

Biopharmaceutical

biologicsbiopharmaceuticalsbiologic
The most common clinical trials evaluate new pharmaceutical products, medical devices (such as a new catheter), biologics, psychological therapies, or other interventions.
Approval may require several years of clinical trials, including trials with human volunteers.

Food and Drug Administration

FDAU.S. Food and Drug AdministrationUnited States Food and Drug Administration
Food and Drug Administration (FDA) organizes and monitors the results of trials according to type:
As a condition of approval, a sponsor may be required to conduct additional clinical trials, called Phase IV trials.

Electronic data capture

data captureEDC
Web-based electronic data capture (EDC) and clinical data management systems are used in a majority of clinical trials to collect case report data from sites, manage its quality and prepare it for analysis.
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.

Clinical trial management system

CTMSClinical trial management systems
Clinical trial management systems are often used by research sponsors or CROs to help plan and manage the operational aspects of a clinical trial, particularly with respect to investigational sites.
A Clinical Trial Management System (CTMS) is a software system used by biotechnology and pharmaceutical industries to manage clinical trials in clinical research.