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Stakeholder perspectives regarding pragmatic clinical trial collateral findings
Stephanie R Morain1, Debra J H Mathews2,3, Kevin Weinfurt4
1Center for Medical Ethics and Health Policy Baylor College of Medicine Houston Texas USA.
Learning Health Systems
|October 20, 2021
Summary
Pragmatic clinical trial collateral findings (PCT-CFs) are increasing, yet lack clear management guidelines. Future planning and stakeholder input are crucial for addressing these unanticipated results in healthcare research.
Area of Science:
- Health Services Research
- Clinical Trials Methodology
- Bioethics
Background:
- Pragmatic clinical trials (PCTs) are expanding due to cost-effectiveness and healthcare decision-making benefits.
- PCTs present unique challenges, including the management of pragmatic clinical trial collateral findings (PCT-CFs).
- PCT-CFs are unanticipated results unrelated to primary research but with potential implications for patients and healthcare systems, yet guidance is lacking.
Purpose of the Study:
- To explore stakeholder experiences and perspectives on managing PCT-CFs.
- To identify key themes and challenges associated with PCT-CFs in pragmatic clinical trials.
- To inform the development of policies and practices for PCT-CF management.
Main Methods:
- Conducted semi-structured interviews with 41 key stakeholders in PCT conduct, oversight, and health system leadership.
- Employed qualitative analysis to identify emergent themes regarding PCTs and PCT-CF management.
- Explored experiences and reactions to actual or hypothetical PCT-CF management scenarios.
Main Results:
- Four key themes emerged: ambiguity in PCTs and their results, context-specific nature of PCT-CF management, diverse views on researcher responsibilities, and a lack of prior consideration but strong support for prospective planning.
- Discussions surrounding PCT-CFs are complicated by the inherent nature of PCTs and unanticipated findings.
- Management strategies for PCT-CFs are highly context-dependent and do not follow a universal approach.
Conclusions:
- PCT-CFs are an increasing concern in pragmatic clinical trials, often without experienced personnel for decision-making or disclosure.
- Further ethical deliberation and the development of implementation processes for PCT-CFs are necessary.
- Involving diverse stakeholders, including professionals, policymakers, and patients, is essential for creating effective policies and practices for PCT-CFs.
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