Considerable efforts are being invested into expanding the use of pragmatic clinical trials (PCTs). While PCTs promise to generate actionable evidence more rapidly and at lower cost than traditional explanatory trials, they also present ethical challenges. This project takes a deep dive into one particular such challenge, namely, the identification and management of incidental findings in PCTs.
Through key stakeholder interviews, patient focus groups, and a national survey, this project will develop an empirically informed, ethically sound approach for managing incidental findings in PCTs.
Supported by: NIH Collaboratory
Johns Hopkins Investigators:
Morain SR, Mathews D, Weinfurt K, May E, Bollinger JM, Geller G, Sugarman J. Stakeholder perspectives regarding pragmatic clinical
trial collateral findings. Learning Health Systems. Published online first
Bollinger J, Geller G, Weinfurt K, May E, Morain SR, Mathews DJ, Sugarman J. Patients’ Views about the Disclosure of Collateral Findings in Pragmatic Clinical Trials. J Gen Intern Med. Published online first August 2020.
Morain SR, Weinfurt K, Bollinger J, et al. Ethics and Collateral Findings in Pragmatic Clinical Trials. American Journal of Bioethics. 2020; 20(1): 6-18.
Morain SR, Bollinger J, Mathews D, Sugarman J. Response to Open Peer Commentaries. Ethics and Collateral Findings in Pragmatic Clinical Trials. American Journal of Bioethics. 2020. 20(1): W9-11.
Management of Incidental Findings in Pragmatic Clinical Trials. Monday, Nov. 18, 2019. PRIM&R Advancing Ethical Research Conference. Boston, Mass.
Management of Collateral Findings in Pragmatic Clinical Trials. ASBH Annual Meeting 2020.