Workshop on ‘Good Clinical Practices’ organized at JMCH, Jodhpur

Jaipur: A workshop on ‘Good Clinical Practices’ was recently held at JIET Medical College and Hospital (JMCH), Jodhpur, drawing participation from faculty members and clinical researchers across various institutions. The workshop was conducted in collaboration with PGIMER, Chandigarh and Govt Medical College, Pali, and aimed to strengthen ethical standards, regulatory compliance, and scientific rigor in clinical research.

Dr. Deepak Verma, Principal of JMCH, said the workshop focused on aligning with both international (ICH-GCP) and Indian guidelines for clinical trials, underlining the importance of sound methodology and ethical conduct. He emphasized the growing need for awareness and adherence to good clinical practice standards, especially in the evolving landscape of biomedical research.

Dr. Priyanka Kumawat, Professor and Head of Pharmacology at Govt Medical College, Pali, and recipient of the Rajasthan Gaurav Award 2024, presented the historical development of clinical trials and explained the foundational principles of ICH-GCP and Indian GCP. She also shared practical insights from her own work, using examples of Investigator Initiated Clinical Trials to highlight real-world application.

Dr. Ajay Prakash, Additional Professor of Pharmacology at PGIMER, Chandigarh, addressed the importance of well-structured study designs and the critical role of sponsors in maintaining trial integrity. His presentation included discussions on hypothesis testing, essential biostatistical methods, and the value of real-world evidence in post-marketing surveillance.

Prof. Bikash Medhi, Professor of Pharmacology at PGIMER, Chandigarh, gave an in-depth explanation of India’s New Drugs and Clinical Trials Rules (NDCT 2019). He outlined key regulatory checkpoints for protocol approval and trial execution. Prof. Medhi also discussed the ICMR Guidelines for Biomedical Research, focusing on ethical evaluations, assessing risk versus benefit, and ensuring protection for vulnerable populations. He concluded with a session on the responsibilities and ethical oversight functions of Institutional Ethics Committees.

Dr. Mahima Khatri, Organizing Secretary of the workshop, said the sessions were designed to equip participants with the knowledge and tools to uphold the highest standards of Good Clinical Practice in their institutions and research projects. She added that continued professional training of this kind is vital for promoting excellence and integrity in clinical research across the country.