Identification and management of pragmatic clinical trial collateral findings: A current understanding and directions for future research.

Journal Article (Journal Article)

While the embedded nature of pragmatic clinical trials (PCTs) can improve the efficiency and relevance of research for multiple stakeholders, embedding research into ongoing clinical care can also involve ethical and regulatory challenges. An emergent challenge is the management of pragmatic clinical trial collateral findings (PCT-CFs). While PCT-CFs share some features with incidental or secondary findings that are encountered in conventional clinical trials and clinical care, the PCT context differs in ethically relevant ways that complicate PCT-CF identification and management. We report on the results of a two-year multi-method investigation of PCT-CFs. Overall, five core themes emerged: 1) the liminal nature of PCTs and the implications of this for PCT-CFs; 2) the context-specific nature of PCT-CF management; 3) the centrality of institutions; 4) the importance of prospective planning; and 5) patient expectations. Among the central lessons of this work are that prior ethics guidance from other settings cannot easily be adapted to address PCT-CFs, nor can a single approach readily accommodate all PCT-CFs. Moving forward, stakeholders, including researchers, institutions, ethics oversight bodies, and funders, should anticipate and plan for PCT-CFs in the design, conduct, and analysis of PCTs. Future scholarship is needed to examine experiences with PCT-CFs, and the practical and conceptual issues they raise for the future conduct of PCTs.

Full Text

Duke Authors

Cited Authors

  • Morain, SR; Mathews, DJH; Geller, G; Bollinger, J; Weinfurt, K; Jarvik, JG; May, E; Sugarman, J

Published Date

  • December 2021

Published In

Volume / Issue

  • 9 / 4

Start / End Page

  • 100586 -

PubMed ID

  • 34600345

Pubmed Central ID

  • PMC8664991

Electronic International Standard Serial Number (EISSN)

  • 2213-0772

Digital Object Identifier (DOI)

  • 10.1016/j.hjdsi.2021.100586


  • eng

Conference Location

  • Netherlands