Clinical trials are sets of tests in medical research and drug development that generate safety and efficacy data (or more specifically, information about adverse drug reactions and adverse effects of other treatments) for health interventions (e.g., drugs, diagnostics, devices, therapy protocols). They're conducted only after satisfactory information has been gathered on the quality of the nonclinical safety, and health authority/ethics committee approval is granted in the country where approval of the drug or device is sought.
Depending on the type of product and the stage of its development, investigators initially enroll volunteers and/or patients into small pilot studies, and subsequently conduct larger scale studies in patients that often compare the new product with others already approved for the affliction of interest. As positive safety and efficacy data are gathered, the number of patients is typically increased. Clinical trials can vary in size, and can involve a single research entity in one country or many such entities in multiple countries.
A full series of trials may incur sizable costs, and the burden of paying for all the necessary people and services is usually borne by the sponsor, which may be a governmental organization or a pharmaceutical or biotechnology company. When the diversity of required support roles exceeds the resources of the sponsor, a clinical trial is managed by an outsourced partner, such as a contract research organization or a clinical trials unit in the academic sector.
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... published in each journal, on the control over clinical trials exerted by sponsors, particularly targeting the use of contracts which allow sponsors to review ... may be restricted from contributing to the trial design, accessing the raw data, and interpreting the results ... Seeding trials are particularly controversial ...
... on October 3, 2005, CancerVax announced the discontinuation of its Phase 3 clinical trial of Canvaxin in patients with Stage III melanoma ... (DSMB) with oversight responsibility for the clinical trial ... at the third interim analysis, that it was unlikely that the trial would provide significant evidence of a survival benefit for Canvaxin-treated patients ...
... form (or CRF) is a paper or electronic questionnaire specifically used in clinical trial research ... Form is the tool used by the sponsor of the clinical trial to collect data from each participating site ... All data on each patient participating in a clinical trial are held and/or documented in the CRF, including adverse events ...
... after being shown in small preclinical trials to have positive effects on persons suffering from Alzheimer’s disease ... Preliminary results from human trials have also been promising ... In an initial six-month phase II trial, results have shown significant improvement over placebo at 12 months ...
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