What will Clinical Research Look Like in 5, 10, 20 Years? Are We Heading to Heaven, Hell or Purgatory? Part 3 of 4

Part-3

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.

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Jonathan Zung: Will AI allow sponsors to dramatically reduce the number of subjects in a trial?

Sagar:

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?

Sagar:

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?

Sagar:

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.

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Moderator: Jonathan Zung:

Member of Saama’s Clinical Board of Advisors and EVP, WCG

Speaker: Sagar Anisingaraju:

Chief Strategy Officer of Saama Technologies

 

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About Sagar Anisingaraju

mmAs Saama’s Chief Strategy Officer, Sagar Anisingaraju creates strategic initiatives that lead Saama into emerging business areas and products with competitive differentiation. Sagar was recognized by PM360 in 2019 as one of the "100 Most Influential People in the Healthcare Industry" for his expertise as a strategist. Northwestern University’s Kellogg School of Management published a case study on the transformation journey that Sagar led for its MBA class of 2018. Sagar was also recognized as the Chief Strategy Officer of the Year in 2013 by Innovation Enterprise.


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