An Overview of Clinical Trial Review Processes in India: Roles and Responsibilities of Regulatory Bodies

A clinical trial is a research investigation involving human participants aimed at addressing specific health-related inquiries. When conducted meticulously, clinical trials represent the quickest and most secure means of identifying effective treatments and enhancing health outcomes. Investigational studies assess the safety and efficacy of novel therapies or new applications of established treatments within a controlled setting. Observational trials examine health-related topics within large populations in natural environments. The primary objective of clinical trials is to evaluate therapeutic effectiveness, and they represent a crucial and highly specialized type of biological assessment. In phase I, clinical pharmacologists investigate pharmacokinetics, safety, and overall effects in human volunteers. If a drug successfully meets the criteria, it progresses to phase II testing, where pharmacokinetics, safety, and therapeutic efficacy are analysed in a select group of patients by clinical pharmacologists. Following successful outcomes in phase II, hundreds of patients are assessed primarily for safety and therapeutic effectiveness by clinical investigators in phase III. Upon passing this phase, the drug receives approval and becomes available in the market. Even after market release, health professionals from various hospitals and clinics provide feedback on the drug concerning adverse drug reactions (ADRs) and efficacy during phase IV.