Clinical Trial Law and Legal Definition
Clinical trial means a scientifically designed and executed inquiry on the effects of a drug administered to human volunteers. Clinical trials are performed by a small number of highly qualified investigators at specified sites in strict compliance with a clinical protocol and all applicable laws, regulations and guidelines, good clinical practices, and the quality standards required by the Food and Drug Administration (FDA). These clinical trials are highly confidential endeavors, and each employee at the clinical trial site is bound to explicit written confidentiality and non-disclosure agreements. It helps to find out the safety, clinical efficacy, and pharmacological effects including toxicity, side effects, incompatibilities, or interactions of the drug. The U.S. government requires strict testing of all new drugs and vaccines by FDA prior to their approval for use as therapeutic agents.