The Covid-19 pandemic has highlighted globally, in the minds of public, the importance of clinical trials in proving the safety and efficacy of any intervention for treating or preventing any disease.
Due to the pandemic induced lockdown, several steps were taken to ensure the safety of the trial participants and the study teams, and to preserve the integrity of clinical trial data.
Digital technologies were used significantly for this – be it in connecting the clinical trial sites with the trial participants to evaluate their safety and well-being, or to deliver the investigational medicinal products directly to the trial participants’ homes in a contactless manner while preserving the product quality and integrity, or using the home healthcare services for performing some study related evaluations, drug administration, etc.
Thus, the pandemic accelerated the deployment of various elements of decentralized clinical trials (DCT). DCT makes it more convenient for the clinical trial participants to participate in clinical trials by providing flexibility for e.g., certain clinical trial visits can be performed at the participant’s own location rather than visiting the hospital sites, digital consent, directly receiving investigational medicinal products at their home, use of tele/videoconferencing to connect with their investigator and site team members, etc.
The deployment of DCT has increased significantly in India for the conduct of clinical trials. Also, based on the learnings from this pandemic, the clinical trial protocol designs now have been including measures to preserve the clinical trial integrity in case such a disruption would occur again.
The pandemic also highlighted the importance of collecting and analyzing real world data (RWD). Today, with the significant increase in adoption of digital technologies, RWD is becoming increasingly important element for planning and conduct of clinical trials.
Many of these changes implemented during this pandemic are here to stay since they help ensure the safety of trial participants while making their participation more convenient and at the same time help in preserving the integrity of trial data while collecting the clinical trial data faster.
Profile of Dr. Chirag Trivedi, Sr. Director, Clinical Study Unit Cluster Head-India &South East Asia, Sanofi
Work Experience:
Currently working in Sanofi as Global Head, Clinical Study Units (CSU) Early Operational Strategy.
Was previously the Director and Head of Clinical Study Unit India and South East Asia Cluster - overseeing clinical studies in India, Singapore, Malaysia, Thailand, Indonesia, Philippines, Bangladesh, Sri Lanka and Vietnam.
Been with Sanofi since 2006 and have handled various roles and responsibilities in these years.
Prior to Sanofi, worked in a CRO and prior to that, in a Central Lab.
From April 2017 to March 2021, was the President of Indian Society for Clinical Research (ISCR) for a total of two terms. As a Society, ISCR brings together all those who are engaged in clinical research activities in India and provides a forum for exchange of information and learning. ISCR aims to build awareness of clinical research as a specialty in India and to facilitate its growth in the country while helping to evolve the highest standards of quality and ethics.
Experienced in the fields of Clinical Research, Clinical Quality Assurance, Medical Excellence, Pharmacovigilance, Bioavailability & Bioequivalence Studies, and Business Development.
Educational Qualification:
Ph.D. in Pharmacology