ISSN: 2474-9214
Authors: Mohammad Nadeem Khan
The total number of clinical trials registered so far across India was 63,174. Clinical trials from India accounted for only 8.7% of the total number of trials conducted, while clinical trials from the US accounted for 47% of the total number of trials registered, followed by 24% from the EU and 13.1% from Japan. We can increase the number of clinical trials by ensuring the role of pharmacovigilance in investigational new drug (IND) clinical trials in ensuring safety, efficacy and ethical conduct of pharmaceutical research. As pharmaceutical companies advance novel compounds through clinical development, pharmacovigilance serves as a comprehensive system for the detection, assessment, and mitigation of potential risks associated with investigational drugs. This perspective review explores the multifaceted role of pharmacovigilance in IND clinical trials, emphasizing its significance in safeguarding trial participants and contributing to the overall success of drug development programs. Underscores the critical role of pharmacovigilance in investigational new drug clinical trials From pre-trial planning to post-marketing surveillance, pharmacovigilance is integral in maintaining the safety, integrity, and ethical conduct of clinical research. As an essential component of the drug development process, pharmacovigilance contributes to the overarching goal of delivering safe and efficacious treatments to patients and can be increase the clinical trial participation globally.
Keywords: Pharmacovigilance; Clinical Trials; Safety; Efficacy; Data Monitoring; Adverse Drug Reaction
