Workshop on ‘Good Clinical Practice’
Aligarh: The recently held National workshop on ‘Good Clinical Practice’ of the Department of Pharmacology, Jawaharlal Nehru Medical College (JNMC), Aligarh Muslim University (AMU) brought together resource persons from across the Country to outline and discuss international quality standards and regulations for clinical trials.
Sharing insights on clinical trials in vulnerable population, Prof Vandana Roy (Maulana Azad Medical College, Delhi) said: “Many persons enrolled in clinical trials can be considered vulnerable, and such trials often raise concerns because of the diminished ability of vulnerable persons to consider and protect their own interests—therefore it is imperative to find out which interventions are effective, which have no impact and which do more harm than good”.
She identified specific challenges associated with randomised clinical trials in vulnerable populations and suggested potential solutions to overcome these problems.
Discussing the importance of the Informed Consent Process, Dr Sudhir Sarangi (All India Institute of Medical Science-AIIMS, New Delhi) pointed out: “Informed consent means that the clinical trial participants are explained the purpose of research, including what their role would be and how the trial will work”.
“People willing to be clinical trial subjects must know the expected length of time for participation, the procedures that will be completed during enrollment on the clinical trial and those that will be completed during the clinical trial, the predictable risks and the discomforts that could occur as a result of the research”, he said.
Prof MU Rabbani (Dean, Faculty of Medicine) stressed the need for conducting multicenter clinical trials involving a larger number of participants from diverse geographic locations.
Prof Rakesh Bhargava (Principal, JNMC) called for regularly training faculty members and postgraduate students to enhance their understanding and expertise on Good Clinical Practice.
Dr Manoj (Senior Drug Safety Physician) delivered a talk on pharma industry’s perspective on safety reporting of serious adverse drug reactions.
Prof Waseem Rizvi (Organising Chairman of the workshop) spoke on the responsibilities and roles of the clinical trial sponsors and Dr Syed Shariq Naeem (Organising Secretary) shared the steps to initiate academic clinical trials.
Prof Shameem Ahmad, Dr Jameel Ahmad, Dr Bushra Hasan Khan and Dr Irfan Ahmad Khan explained the ways for seeking cognizance towards principles of good clinical practice and roles and responsibilities of various stakeholders involved in clinical trials.
More than 45 doctors of different specialties participated in the workshop.