Apollo Hospitals Educational And Research Foundation (AHERF) organised a ‘National Conference on Evolving Roles of Ethics Committees in India’ in Delhi with the objective of increasing awareness, aligning all stakeholders on current state, discussing and identifying key changes required on the regulatory and industry front, identifying responsibility amongst stakeholders and charting out the roadmap to strengthen ethical conduct of clinical research in India.
The one and a half day long conference reportedly provided a platform for the convergence of key stakeholders and facilitated an exchange of ideas through plenary sessions and panel discussions which resulted in a productive dialogue on ethics in clinical research. Further, as part of the conference, a hands-on workshop on Ethics Committee processes was conducted to impart education on ethics committee operations and best practices.
The conference also witnessed the presence of various sites and institutions which are key stakeholders in the conduct of clinical trials. Dr Sita Naik, Advisor to Chairman, Research Task Force, Apollo Hospitals, said “Although Ethics Committees have been around for some time, there is a genuine lack of understanding of the issues involved by both the investigators and members. There is an urgent need to have training programs at various levels in order to increase the pool of competent ethics professionals. Programmes like the present meeting, are aimed to widen the net and increase the awareness.”
From another perspective, Seemant Jauhari, CEO, AHERF added “conduct of clinical trials is perhaps an inevitable component of thedrug development process. The only option is to undertake it with great responsibility and the stakeholders should ensure their conduct with accountability governed by clear regulatory processes. However such processes must be balanced enough to allow effective yet efficient evaluation of studies in India. A well-focussed group, with wide representation of all stakeholders should champion this topic consistently and contribute to establishing benchmarks in ethical conduct of trials“
Speaking on the occasion, Dr Mubarak Naqvi, Senior Director, Clinical Study Unit, Sanofi said, “The mission and purpose of the healthcare industry is to address patients’ needs by providing them with appropriate therapeutic solutions. To meet unmet medical needs of patients, clinical trials become a mandatory part of the drug discovery, development and marketing approval process. As medical practitioners and researchers committed to the safety and health of our patients, it is our responsibility to ensure that clinical trials are conducted with appropriate regulatory and ethics approvals and are in line with Good Clinical Practice (GCP) guidelines. Hence, the role of the Ethics Committees and the laws regulating their functioning become ever so critical to the future of clinical research.”
EH News Bureau