Listening to Patient Voices Will Lead to Better Trial Registries

Sue McHale

Sue McHale, MS, AstraZeneca,

When a recent global survey with more than 3,000 participants found that more than 70% of U.S. respondents are interested in the possibility of volunteering for a clinical trial, but even more are not aware of any trials being available for their (or the person’s they are caring for) condition, the obvious question was “So, where to we go from here?” said Sue McHale, MS, executive director of clinical operations with AstraZeneca, at an ACRP 2018 session today (April 28). “There’s information out there, but obviously, it’s not enough or in the right place for people to use it,” she added during her presentation on “The Patient Voice: Improving Patient Experience by Understanding the Patient Perspective.”

Speaking on behalf of TransCelerate Biopharma Inc., a collaboration of 19 major sponsor companies seeking to improve the health of people around the world by accelerating and enhancing the research and development of innovative new therapies, McHale outlined the goals and progress to date of a patient-centered initiative by the group to foster what it calls the Clinical Trial Registry of the Future (ROTF).

“I think we all thought we had an understanding [of what the patient experience was] in the industry, but now you can see that was probably quite tunneled,” McHale said. Among other facets of the process of engaging and retaining subjects in clinical trials, this tunnel vision was evident from patients’ reactions to how difficult they found navigating the registry to be when seeking information on trials they might join, she noted.

Thus, the ROTF is envisioned as a resource for patients to search for and access information written in straightforward language about relevant trials in all therapeutic areas from a trusted, central location. McHale said the goal is not that the ROTF will be developed by anyone as a fully functional platform or as a template to be replicated in its entirety, but that it will be a conceptual framework and tool to start a broad conversation about changes to existing, cumbersome, government-sponsored registries. The ROTF model will describe feedback gathered directly from patients on their desires and preferences for future registries.

McHale said ongoing work on the initiative focuses on “what needs to change [and what] we need to do…to make the registries much more useful going forward.”

Author: Gary Cramer