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Article: Registration and reporting of clinical trials
- Article from:
- Indian Journal of Dermatology, Venereology and Leprology
- Article date:
- January 1, 2008
- Author:
CopyrightCopyright Medknow Publications Jan/Feb 2008. Provided by ProQuest LLC. (Hide copyright information)
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Clinical trials form an integral part of the drug discovery process worldwide. However, registration of clinical trials is not restricted to drug interventions. A clinical trial is defined as "any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes." [1] Interventions include not only drugs but also cells and other biological products, surgical procedures, radiologic procedures, devices, behavioral treatments, process-of-care changes, preventive care, etc. A set of guidelines are already in place in India for the ethical conduct of studies to safeguard the interests of ...