Stakeholders welcome positive developments in the regulatory environment welcomed by stakeholders
The 9th Annual Conference of the Indian Society for Clinical Research (ISCR) recently concluded with a strong iteration on the importance of clinical research in India to provide better, safer and more accessible treatment for patients. There was also unanimous agreement that the changing regulations in 2015 had provided a fresh impetus to doing clinical research in India even while delegates welcomed the more recent draft amendment to the Drugs and Cosmetic Rules 1945 to encourage academic research.
The second day of the conference focused on topics such as site quality, clinical operations quality, ensuring quality in ethics committee, investigator initiated research, collaborative research and understanding the various career opportunities in clinical research for students and young professionals. Speakers emphasised the need for young talent that is passionate and willing to bring about a change in the clinical research industry. Sessions also focused on opportunities in medical writing, regulatory strategy and operations, marketing, sales, pharmacovigilance/safety and product management.
Suneela Thatte, President, ISCR said, “Over the last two days, we have deliberated at length on the requirements that will make clinical research go back to its former growth track in India. As a society that stands for Patients First and Research for India, we need to ensure that while research on new therapy takes place, it does not happen at the cost of human rights, patient safety and research ethics.”
The highlight of the second day was understanding the purpose of investigator initiated research in navigating the new environment for doing research in India. The session had representation from the heads of industry and academic institutions/hospitals in the country to discuss the changes in regulations and conducting research in times of uncertainty, the challenges faced by various stakeholders in carrying out multinational collaborative research and the value of re-purposing drugs for current health needs.
In an earlier panel on why site quality is everyone’s responsibility, panelists stressed on the importance for investigators in a trial to maintain a balance between being a researcher and a treating physician. They also highlighted that robust regulations, well-functioning ethics committees, trained investigators, committed site staff and well informed subjects are all equally important in improving site quality.
The final day concluded with the release of the findings of a research study done at the venue which saw more than a 75 per cent participant response. The findings provided important and interesting insights on perceptions about the current external environment in India and what participants needed to be done to help rebuild a more enabling environment for clinical research in India. Close to 60 per cent of the participants also renewed their pledge to commit to a more ethical clinical research environment in India in a booth that was sponsored by Sanofi India.
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