Caleigh Propes

December 3, 2024: Sharing Results With Research Participants Raises Special Considerations in Pragmatic Trials

Posted on by Damon Seils

Cover image of the journal Clinical TrialsIn a new report from the NIH Pragmatic Trials Collaboratory, a team of bioethicists explores the ethical obligation to share aggregate results from pragmatic clinical trials with research participants. They conclude with recommendations for how to meet this obligation.

The article was published online ahead of print in Clinical Trials.

There is growing appreciation of the importance of sharing aggregate results of clinical trials with research participants. However, this practice has not been examined in the context of pragmatic clinical trials, which have special features that may complicate the ethics and logistics of sharing aggregate results.

The report’s authors summarize the ethical arguments for sharing aggregate results and describe the features of pragmatic trials that may raise logistical and other barriers to disclosure. They also discuss the important role healthcare system partners play in sharing results from pragmatic trials.

The authors offer the following recommendations:

  • Sharing aggregate results with research participants should be the default, and decisions not to share should be justified
  • Planning for sharing aggregate results should begin early in the planning of the trial
  • The healthcare care systems in which the trial is embedded should be key partners in decisions about what and how to share
  • Proactive sharing of results from a pragmatic trial that was conducted under a waiver or alteration of consent, including an explanation for why consent was not obtained in the study, can promote trust in the investigators and their healthcare system partners

Read the full report.

The article was coauthored by members of the NIH Pragmatic Trials Collaboratory’s Ethics and Regulatory Core, including Stephanie Morain, Abigail Brickler, Joseph Ali, Caleigh Propes, and Kayla Mehl of Johns Hopkins University; Pearl O’Rourke, formerly of Partners HealthCare; Kayte Spector-Bagdady of the University of Michigan; Benjamin Wilfond of the Seattle Children’s Hospital; Vasiliki Rahimzadeh of the Baylor College of Medicine; and David Wendler of the NIH Clinical Center.

November 21, 2024: Are Pragmatic Trials Living Up to the Promise of Improving Representativeness?

Posted on by Damon Seils
Headshots of Stephanie Morain, Kayla Mehl, and Caleigh Propes
(Left to right) Authors Stephanie Morain, Kayla Mehl, and Caleigh Propes

In a new commentary, members of the NIH Pragmatic Trials Collaboratory’s Ethics and Regulatory Core explore the potential of pragmatic trials to improve demographic representativeness and health equity in clinical research. The article, “Untapped Potential? Representativeness in Pragmatic Clinical Trials,” was published online ahead of print in JAMA.

Authors Caleigh Propes, Kayla Mehl, and Stephanie Morain review early experiences with pragmatic trials and describe the challenges researchers face in achieving representative enrollment:

  • Pragmatic trials are embedded in unjust healthcare systems
  • Pragmatic trials often rely on electronic health record systems for data collection
  • As in traditional clinical trials, site selection in pragmatic trials tends to be biased toward better-resourced sites and sites with closer ties to established researchers
  • There is a general lack of attention to health equity considerations in trial design

The authors conclude that “further empirical scholarship is needed to assess the extent to which [pragmatic trials] are (or are not) truly representative and to define appropriate enrollment goals.”

Read the full article.

Propes is a doctoral student in bioethics and health policy and management at the Berman Institute of Bioethics, Mehl is a postdoctoral fellow in the ethics and regulatory aspects of pragmatic clinical trials at the Berman Institute, and Morain is a core faculty member at the Berman Institute and an associate professor of health policy and management at the Bloomberg School of Public Health—all at Johns Hopkins University.

July 23, 2024: Article From Ethics and Regulatory Core Highlights Key Challenges for Pragmatic Trials

Posted on by Damon Seils

Headshots of Caleigh Propes, Stephanie Morain, and Pearl O'RourkeIn an invited commentary published this month in Circulation: Cardiovascular Quality and Outcomes, authors from the NIH Pragmatic Trials Collaboratory’s Ethics and Regulatory Core describe the recurring and emerging ethical issues in pragmatic clinical trials.

Coauthors Caleigh Propes, Stephanie Morain, and Pearl O’Rourke discuss 3 key challenges facing pragmatic trials researchers:

  • waivers and alterations of informed consent and their implications for transparency
  • managing and responding to “collateral findings” in pragmatic trials
  • representativeness of study populations, and the risk of reinforcing existing inequalities in healthcare delivery systems

Read the full article.

Each of the 3 challenges has taken on increasing importance for the NIH Collaboratory’s Ethics and Regulatory Core. For example, the group completed a 2-year multimethod investigation of collateral findings in pragmatic trials, identifying the core themes and proposing directions for future research.

Propes is a doctoral student in bioethics and health policy, and Morain is an associate professor of health policy and management and a core faculty member of the Berman Institute of Bioethics—both at Johns Hopkins University. O’Rourke is a retired bioethicist who served as the director of human research affairs at Partners HealthCare Systems in Boston and as an associate professor of pediatrics at Harvard Medical School.

Learn more about the Ethics and Regulatory Core.