REGULATIONS GOVERNING CLINICAL TRIALS IN INDIA, EUROPE AND USA- A COMPARATIVE STUDY
Abstract
Clinical trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective for humans. These studies also may show which medical approaches work best for certain illnesses or groups of people. The purpose of clinical trials is research, so the studies follow strict scientific standards. These standards protect patients and help produce reliable study results. Clinical trials are one of the final stages of a long and careful research process. The process often begins in a laboratory (lab), where scientists first develop and test new ideas. If an approach seems promising, the next step may involve animal testing. This shows how the approach affects a living body and whether it is harmful. However, an approach that works well in the lab or animals does not always work well in people. Thus, research in humans is needed.
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