Benefits and Challenges of Pragmatic Trials for Individuals with Intellectual and Developmental Disabilities

This Vanderbilt Kennedy Center Research Ethics Grand Rounds Panel Discussion was presented on December 14, 2022.

Pragmatic trials are different from conventional clinical trials because pragmatic trials are embedded within ongoing clinical care in a healthcare setting. When they work well, pragmatic trials open recruitment to a much broader group of people, which increases likelihood of diversity in age, gender, and ethnicity among its research participants. Pragmatic trials are not without their challenges, however. Burden is placed on clinicians to participate in additional trainings and follow research protocols while continuing to interact with their patients. On the other side, research participants (or their caregivers) may be asked to give up an element of control in their care as part of the participation process.

What do pragmatic trials look like for research participants who have intellectual or developmental disability, or the healthcare providers who serve them? Once the trial has started, how does the trial evolve as more information comes to light?


  • Beth Malow, M.D., M.S., Burry Chair in Cognitive Childhood Development; Professor of Neurology and Pediatrics; Director, Vanderbilt Sleep Disorders Division
  • Angie Maxwell-Horn, Ph.D., Assistant Professor of Pediatrics
  • Jeff Neul, M.D., Ph.D., Annette Schaffer Eskind Chair and Director, Vanderbilt Kennedy Center; Professor of Pediatrics, Division of Neurology, Pharmacology, and Special Education
  • Sarika Peters, Ph.D. (Moderator), Associate Professor of Pediatrics and Psychiatry & Behavioral Sciences

Last Updated: 12/16/2022 10:54:01 AM

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