The following is the third installment of the excerpted panel discussion, “Future Visions: Are We Heading to Heaven, Hell or Purgatory?,” that Saama Technologies’ Chief Strategy Officer Sagar Anisingaraju participated in on October 28 at MAGI’s Clinical Research Conference – 2019 West, in Las Vegas. The discussion was moderated by Jonathan Zung, Ph.D., member of Saama’s Clinical Board of Advisors and EVP, WCG.
Jonathan Zung: Will AI allow sponsors to dramatically reduce the number of subjects in a trial?
AI achieves better pattern and outlier detection across many attributes in a way that is not humanly possible, giving us exciting opportunity to stratify patients better. Trials will thus need fewer subjects. Direct-from-patient data will also impact subject sample size. With the advent of higher compute engines at reasonable costs, patients need not be analyzed as large cohorts for broad-based analysis. We can analyze them at smaller precision groups and reduce the need for larger samples. Overall, we will see better data-driven techniques being integrated into protocol design and feasibility. These will reduce the need for large numbers of subjects.
New waves of study designs, including umbrella, basket, and platform combined with algorithms that can merge computational biology, translational medicine, clinical science, EMR and other datasets, will allow us to simulate the most likely paths of cohorts. Thanks to AI, the path of highest probability of technical and regulatory success (PTRS) will be better understood in the near future using fewer targeted subjects.
Jonathan: Will remote trials be part of our normal in 2025?
Absolutely. Remote trials will be the key strategic move to increase the number of patients willing to participate, versus today’s low, often single-digit numbers. By removing logistical issues such as travel, taking time off work, etc., more patients will be willing to contribute. All the technical and infrastructural components to enable remote trials will advance over the next five years, or sooner.
Jonathan: What incentives are required to speed up innovation in clinical trials?
There are enough incentives in the system. Risk aversion is the issue. The broader question is also how R&D moves its goalposts from regulatory submission and approval to market access and reimbursement. The industry can only achieve the vision of helping people live longer, healthier, and more productive lives if patients can access the new innovations globally.
Moderator: Jonathan Zung:
Member of Saama’s Clinical Board of Advisors and EVP, WCG
Speaker: Sagar Anisingaraju:
Chief Strategy Officer of Saama Technologies