Re: “There Was No Opportunity to Express Good or Bad”: Perspectives from Patient Focus Groups on Patient Experience in Clinical Trials

The publication by Boyd et al ¹ reported qualitative research characterizing how clinical trial participants’ experiences in research are assessed during and after study participation. Participants provided actionable feedback about factors contributing to positive or negative research experiences and expressed frustration that they are rarely asked for feedback about their experiences. In response, the authors called for efforts “to develop and validate a standardized clinical trial patient experience instruments (sic) across a variety of clinical trials….(that will) facilitate patient-centric quality improvement.” We are concerned that the authors are unaware of initiatives already underway to fulfill their call to action. As the authors of the Research Participant Perception Survey (RPPS)^2–4 we measure, report, and act on participants’ research experience feedback using this validated instrument to standardize experience measurement across diverse populations and settings for benchmarking and participant-centered quality improvement.

Our recent work, funded by the National Center for Advancing Clinical Translational Science, advances implementation by addressing institutional barriers to the adoption of the RPPS for collecting participants’ feedback. The Empowering the Participant Voice project, led by Rockefeller University, with Vanderbilt, Duke, Johns Hopkins, Wake Forest, and the University of Rochester, developed, tested, and shared a common infrastructure enabling multi-site surveying tailored to local institutional needs while maintaining data validity and comparability. The platform protects participant privacy and affords blinded comparison of results filtered study and participant characteristics and by custom variables. We aggregate deidentified data on a national analytic dashboard and share tools with research institutions without charge to encourage broad uptake. ⁵

From 2022 to 2024, we aggregated responses from approximately 5000 diverse research participants for aspects of the research experience, including overall experience, likelihood to recommend research, the effectiveness of the informed consent process, respect, trust, attention to language and culture, and other key experiences. Sites compare data, analyze local results, and share plain language summaries with their communities. Sites identified improvement opportunities, engaging communities in outreach, analysis, trust-building, and developing responsive actions. ⁵ These data build on the more than 8000 responses previously reported using earlier versions of the same instrument.^4,5

Participant experience surveys can improve participants’ experiences and impact clinical trial enrollment when research practices are responsive to participants’ feedback. One site responded to survey feedback requesting flexible hours by adding Saturday visits one week per month, increasing accrual by 60% during the weeks with Saturday appointments, a high-impact change. Significant differences in RPPS scores across studies, patient groups, and sites suggest that many better practices can be identified, tailored, and scaled. We hypothesize that once experience data are routinely used to drive research quality improvement efforts, the research enterprise will make strides toward more participant-centered clinical trials.

Participants are eager to provide their feedback, a gift that contains the keys to making research more authentically participant-centered. We enthusiastically support Boyd et al's call to sponsors and research organizations to measure participant experiences by using validated and established frameworks such as RPPS and the EPV initiative to solve some of the most stubborn challenges to advancing clinical research.