ISSN : 2663-2187

A Comprehensive Case Study of the New Drug and Clinical Trial Rules

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K. Narendran, P. Shanmugasundaram
ยป doi: 10.33472/AFJBS.6.9.2024.932-940

Abstract

Clinical trials are essential phases in the process of developing a new pharmaceutical product for market release. They are carefully designed studies that assess the safety and efficacy of a novel medication in human subjects. The process normally has several steps including: Before human trials, preclinical testing evaluates a drug's safety and efficacy in labs and on animals. A small group of healthy volunteers participate in phase 1 clinical studies to assess a drug's safety, dose range, and side effects. Phase 2 Clinical Trials examine the drug in more people with the targeted illness. Additional safety data and efficacy assessment are the goals. Phase 3 clinical studies have a larger patient cohort and provide more extensive drug safety and efficacy data. Randomized, controlled trials often compare the new drug to conventional treatments or a placebo. Phase 4 Clinical Trials, also known as Post-Marketing Surveillance, involve doing further studies to further assess the safety, effectiveness, and optimal utilization of a medicine in real-world scenarios even after it has been approved and made available in the market. Stringent laws and ethical norms are enforced throughout all stages of clinical studies to safeguard the rights and safety of participants. The requirements encompass getting informed consent from participants, following Good Clinical Practice (GCP) principles, and supervision by institutional review boards (IRBs) or ethical committees. In the present study, a questionnaire was prepared and circulated among various stakeholders of the healthcare team. Questions were based upon the New Drug Trial Rules and comparison between the rules and regulations between the different countries to evaluate the pros and cons of regulations of different countries on clinical trial studies so that updations could be demanded based on the same. Important conclusions were drawn based on the questionnaire.

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