2020 has made clinical research even more significant: Experts at ISCR’s annual conference

New Delhi: Reflecting on the experience during the last twelve months, representatives from across the clinical research ecosystem in India highlighted the collaborative efforts of stakeholders that contributed to expedited drug development demanded by the pandemic. Experts concurred that this collaboration would be critical as the industry moved ahead, embracing learnings from the pandemic and incorporating advances in digital health. This was the overarching message as over 1200 members of the clinical research fraternity came together to attend the virtual 14th Annual Conference of the Indian Society for Clinical Research (ISCR) based on the theme ‘Clinical Research – Transforming lives: 2021 and beyond.’

“The importance and significance of clinical trials could not have been more amplified than it was in 2020.  I am happy to say that as a fraternity, we came together to ensure our commitment to Patients First. It was a period when clinical trials became a household name and we now need to build further trust and confidence amongst members of the public in the safety, efficacy and quality focus of clinical trials,” said Dr Chirag Trivedi, President, ISCR.

Delivering the 6th Prof Ranjit Roy Chaudhury Oration, Dr. K. Vijay Raghavan, Principal Scientific Adviser, Government of India, spoke of the need to increase the number of clinical researchers in India and integrate the learnings of basic science with an understanding of research in these areas of medicine to strengthen the country’s clinical research system. He called for more synergy between research establishments and the clinical research community, and the need to break silos to ensure more collaborative efforts and better outcomes.  He also touched upon three areas that needed greater focus and attention of clinical researchers – infectious diseases, rare diseases and precision medicine.

The panel discussion on ‘Accelerated Clinical Development (Therapeutics & Vaccines) in Times of a Pandemic’ addressed how clinical research stakeholders should focus on continuing their efforts to develop vaccines and drugs at the pace that was seen during the pandemic. Elaborating on managing challenges during the early stages of the pandemic, AK Pradhan, Deputy Drug Controller, CDSCO, said, “We had to streamline the system without compromising any norms so that there was no delay. The regulatory review process for all stakeholders was geared up to fast-track drug development and a committee formed to develop and review applications without delay and seamlessly. The learnings around the processes and guidelines followed during the pandemic will be incorporated even after the pandemic is over with one caveat that quality is not affected.”

In his keynote session on Academic Clinical Research, Dr C.S Pramesh, Director, Tata Memorial Hospital, Mumbai spoke on how important it is to do collaborative research that is relevant to provide answers/solutions to unmet medical needs in India.

The conference session was held across five tracks that covered various areas in clinical research such as Clinical Operations, Ethics, Quality, Regulatory and Investigator Track; Academic Clinical Research, Pharmacovigilance and Real World Evidence; Clinical Data Management; Biostatistics and Statistical Programming;  and Medical Writing. Panelists and speakers through the day’s sessions touched upon the learnings and insights gained during the pandemic that augured well for the future of clinical research in ensuring faster and better outcomes for patients.

A highlight of the opening day was the ISCR Lifetime Achievement Awards for academia and industry that was presented to Prof Gagandeep Kang, Christian Medical College, Vellore recognizing her contribution to research in vaccinology and virology and to Dr. Shoibal Mukherjee, Senior Consultant in Pharmaceutical Medicine, for his contribution to innovation in clinical research.