Stakeholder perspectives regarding pragmatic clinical trial collateral findings.

ABSTRACT:

Context

Pragmatic clinical trials (PCTs), which are becoming widespread since they are relatively inexpensive and offer important benefits for healthcare decision-making, can also present practical, ethical, and legal challenges. One such challenge involves managing "pragmatic clinical trial collateral findings" (PCT-CFs), or information emerging in a PCT that is unrelated to the primary research question(s), yet may have implications for individual patients, clinicians, or health care systems from whom or within which data were collected. The expansion of PCTs makes it likely healthcare systems will increasingly encounter PCT-CFs, yet little guidance exists regarding their appropriate management.

Methods

We conducted semi-structured interviews with key stakeholders experien

SUBMITTER: Morain SR 

PROVIDER: S-EPMC8512737 | biostudies-literature | 2021 Oct

REPOSITORIES: biostudies-literature