Enabling Informed Selection of Clinical Trials: Institution, Provider and Participant Responsibilities - The Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard

This meeting of the MRCT Center Bioethics Collaborative will explore the ethical considerations underscoring the challenge of informed selection of clinical trials. We will examine the responsibilities of various stakeholders within the clinical trial ecosystem, and we will discuss potential solutions.

The current landscape of clinical trial identification, referral, selection, and enrollment depends largely upon access to clinical trial information by a multiplicity of stakeholders. Unfortunately, access to this information is fragmented. Treating physicians do not routinely discuss clinical trials with their patients; investigators recommend enrollment in the clinical trials in which they or their institution are involved, but often not others; institutional IRBs evaluate the potential benefit/risk calculus for a given trial without consideration of the entire landscape of competitive trials; institutions do not consistently provide patients with instructions or guidance on navigating patient advocacy and trial registry websites, nor do they refer patients to external resources (e.g., patient advocacy groups and disease advocacy organizations) to help navigate the choice among alternative trials; existing clinical trial databases are often incomplete and complex, and they do not convey information in ways that help patients and providers choose among available trials. As a result, patients’ knowledge of their clinical trial options is often incomplete, and enrollment decisions are based on limited information.

Patients can, and often want to, be empowered with clinical trial information that is understandable and accessible. But institutional walls appear to have created artificial boundaries around the choice of clinical trials. We have not equipped patients to compare the suitability of the clinical trial(s) offered by their physicians with those offered down the block or across the river, concordant with their own preferences. As availability of electronic information increases (and with the appreciation that more information is not necessarily better information), our current systems may be improved to better uphold the foundational ethical principles of clinical research. These principles—respect for persons, beneficence, and justice—and their application to how we offer, and how patients select, clinical trials deserve review.

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