Abstract
BackgroundThere is a widely recognized need for more pragmatic trials that evaluate interventions in real-world settings to inform decision-making by patients, providers, and health system leaders. Increasing availability of electronic health records, centralized research ethics review, and novel trial designs, combined with support and resources from governments worldwide for patient-centered research, have created an unprecedented opportunity to advance the conduct of pragmatic trials, which can ultimately improve patient health and health system outcomes. Such trials raise ethical issues that have not yet been fully addressed, with existing literature concentrating on regulations in specific jurisdictions rather than arguments grounded in ethical principles. Proposed solutions (e.g. using different regulations in “learning healthcare systems”) are speculative with no guarantee of improvement over existing oversight procedures. Most importantly, the literature does not reflect a broad vision of protecting the core liberty and welfare interests of research participants. Novel ethical guidance is required. We have assembled a team of ethicists, trialists, methodologists, social scientists, knowledge users, and community members with the goal of developing guidance for the ethical design and conduct of pragmatic trials.MethodsOur project will combine empirical and conceptual work and a consensus development process. Empirical work will: (1) identify a comprehensive list of ethical issues through interviews with a small group of key informants (e.g. trialists, ethicists, chairs of research ethics committees); (2) document current practices by reviewing a random sample of pragmatic trials and surveying authors; (3) elicit views of chairs of research ethics committees through surveys in Canada, UK, USA, France, and Australia; and (4) elicit views and experiences of community members and health system leaders through focus groups and surveys. Conceptual work will consist of an ethical analysis of identified issues and the development of new ethical solutions, outlining principles, policy options, and rationales. The consensus development process will involve an independent expert panel to develop a final guidance document.DiscussionPlanned output includes manuscripts, educational materials, and tailored guidance documents to inform and support researchers, research ethics committees, journal editors, regulators, and funders in the ethical design and conduct of pragmatic trials.
Highlights
There is a widely recognized need for more pragmatic trials that evaluate interventions in real-world settings to inform decision-making by patients, providers, and health system leaders
Examples of pragmatic randomized controlled trials For illustrative purposes, we present three examples of pragmatic trials that raise important ethical issues needing guidance
We seek to create a novel approach to the ethics of pragmatic trials that improves upon the existing literature, which has been criticized for lacking convincing arguments grounded in ethical principles [53], including claims based on erroneous assumptions [54], appealing mainly to regulations in particular jurisdictions [55,56,57], offering speculative solutions with no guarantee of improvement over existing oversight procedures [58], and failing to reflect a broad vision of protecting the liberty and welfare interests of research participants [59]
Summary
There is a widely recognized need for more pragmatic trials that evaluate interventions in real-world settings to inform decision-making by patients, providers, and health system leaders. Increasing availability of electronic health records, centralized research ethics review, and novel trial designs, combined with support and resources from governments worldwide for patient-centered research, have created an unprecedented opportunity to advance the conduct of pragmatic trials, which can improve patient health and health system outcomes. Such trials raise ethical issues that have not yet been fully addressed, with existing literature concentrating on regulations in specific jurisdictions rather than arguments grounded in ethical principles. Trials that are more pragmatic have broader eligibility criteria, recruit participants at the time of presentation, include a diverse range of settings that mirror real-world circumstances, do not require highly specialized training or research personnel, give healthcare providers flexibility in how the intervention is delivered, require no special strategy for monitoring protocol compliance, follow and monitor patients as in routine clinical practice, have clinically meaningful and patient-centered outcomes, and include all randomized patients in analysis
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