Considering the growing demands to get better and affordable treatment options, there needs to be a fundamental shift in drug development and specifically the clinical trials oversight processes to mitigate risks and reduce failures. The International Council for Harmonization (ICH) E6 R2 addendum has now provided guidelines for adaptation of risk-based approach to trial conduct and monitoring to implement mitigation strategies and key risk indicators for potential risks which might derail the conduct of the trial. However, with the changing landscape of drug development which includes novel therapies such as gene therapy, decentralized trials, wearable technologies, eSource, electronic health record interoperability, and implementation of AI ML algorithms, the future of risk-based approach towards managing clinical trials is going to be very different from what we see now.
Dr. Niraj Vyas
Associate Vice President and Head, TCS ADD Analytics and Insights