The Future of Clinical Trial Oversight: What Really Matters

Newly published paper offers a path forward for enhanced trial monitoring

DENVER, April 27, 2022 /PRNewswire/ — An evidence-based approach to clinical trial oversight is key to the future of clinical trial oversight, according to Deepak Bhatt, MD and Penelope Manasco, MD. Their newly published article, "Evaluating the evaluators," now available in Contemporary Clinical Trials, explains why. The authors hope the article will spur discussion within the industry and at NIH to address a critical need.

"There is a great need for more research to identify and optimize methods of oversight of clinical trial monitoring. This is a critical aspect of randomized clinical trials that has not gotten as much attention as it deserves," explained Bhatt, Executive Director of Interventional Cardiovascular Programs at Brigham and Women’s Health and Professor of Medicine at Harvard Medical School.

"Clinical trial monitoring is a multibillion dollar industry.  The methods currently in use are untested and no data are available to understand the critical errors that are missed using these methods. The pharmaceutical, device, vaccine, and CRO industries will all benefit from knowing the most effective methods for monitoring.  It has the potential to save millions of dollars," said Manasco, the founder of MANA RBM, who previously worked at the National Institutes of Health, GlaxoSmithKline, and two clinical research software companies.

"Evaluating the evaluators" outlines a set of recommendations to evolve clinical trial monitoring, including:

  • Developing and providing reference datasets with defined errors 
  • Systematically testing different monitoring methods using reference datasets
  • Publishing details of trial quality to improve community evaluation

Bhatt and Manasco seek to ensure that monitoring methods adopted in the future will be evidence-based, saving money and time while facilitating good science and human subject protection.

For more information and to interview the authors, please contact Dr. Manasco at
 or 919-556-9456.

SOURCE Penelope Manasco, MD