Future of risk based monitoring in clinical trials


  • Niraj R. Vyas Department of Life Sciences, Tata Consultancy Services, Hiranandani Estate, Thane West, Thane, Maharashtra




Risk based monitoring, Centralised monitoring, ICH E6 R2, Key risk indicators, eSource, AI/ML


Drug development is a complex and resource intensive endeavor. The average cost of developing a new drug, has been estimated to be $2 to $3 billion. However, the success rate of clinical trials is very low around and is estimated to be between 3-5%. The common reasons for failure of clinical trials include failure to demonstrate efficacy or safety, budgeting and financing, failure of subjects meeting protocol eligibility criteria, poor investigator site selection, patient withdrawals and dropouts. Considering the growing demands to get better and affordable treatment options, there needs to be fundamental shift required in drug development and specifically the clinical trials oversight processes to mitigate risks and reduce failures. The International Council for Harmonisation in the E6 R2 addendumhas now provided guidelines for adaptation of risk based approach to trial conduct and monitoring to implement mitigation strategies for potential risks which might derail the conduct of the trail. The industry is steadily gearing up to put together the required processes, systems and teams to align to the new ways of working. However with the changing landscape of drug development which includes novel therapies like gene therapy, remote/decentralized trials, growing use of wearable technologies, esource, electronic health record/electronic medical records interoperability, implementation of artificial intelligence and machine learning algorithms, the future of risk based approach towards managing clinical trials is going to be very different from what we see now. This paper explores the impact of these new developments on the future of risk based monitoring in clinical trials.

Author Biography

Niraj R. Vyas, Department of Life Sciences, Tata Consultancy Services, Hiranandani Estate, Thane West, Thane, Maharashtra

With qualification in medicine, clinical research and management, I have experience of working in a centralized core lab, CRO and KPO managing Clinical Operations, Cardiac Safety and Centralized Monitoring in clinical trials for Pharmaceutical and Biotechnology companies. I am currently working as offering lead of Clinical Operations support services and my role is to ensure high standard of delivery to customers, manage key client relationships, drive business transformation initiatives, development of innovative platform solutions, ensure regulatory compliance, manage team performance, develop and implement business unit strategies.


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