June 17, 2019 | TrialAssure, a Canton, Michigan-based global software company, recently launched a web portal for clinical trial sponsors to publicly share plain language, or lay, summaries with clinical trial participants. The portal, called TrialResults.com, allows trial participants to access the plain language summaries in any region of the world and in their native language with ease, simultaneously reducing the burden for sponsors who do not have their own public portal.
Using a unique identifier provided by their trial sponsor, patients can search for their specific trial and review the results in a lay language trial results summary.
The summaries, written either by the trial sponsors or by medical writers through a partnership with clinical research organization MMS, provide details including the purpose of a given clinical trial, results from that trial, the treatment participants received, and the medical problems a patient might have had.
TrialAssure believes the timely posting of these results in a way that is understandable to all participants will lead to a more positive clinical trial experience and strengthen support for future participation and public perception of health sciences research overall.
TrialAssure’s Product Solutions Manager, Zach Weingarden, told Clinical Research News that the new portal is an electronic makeover to an antiquated system.
“As [plain language summaries] become more common, and regulations start to come out ensuring how trials come out with information, one of the challenges is how to distribute this information to patients,” Weingarden said. Traditionally, trial sponsors will mail these documents out to trial participants, but this process often becomes difficult and clunky, especially in a large trial with multiple sites.
The obvious solution is to digitize the process, but rather than simply sending out PDFs through email, which presents its own set of problems, Weingarden says TrialAssure’s portal simplifies the interaction between clinical trial sponsors and the trial participants in a secure, centralized way.
TrialResults.com also offers a degree of transparency that, unfortunately, is often lacking in the clinical trial industry.
“The distribution of this information is overly cumbersome, and it’s been a reason why a lot of sponsors haven’t been able to do as much outreach to patients—especially the ones who are in their trials—as they’d like. It’s a major logistics problem,” he said.
In a press release, TrialAssure pointed to a report by Applied Clinical Trials, saying that only 2% of clinical trial sponsors have issued plain language summaries to participants in the past few years. For many trial participants, trying to understand the clinical trial results as posted to government clinical trial registries can be difficult, given the highly technical scientific jargon.
Weingarden sees trial sponsors leveraging the new system, offering trial participants the ability to see the impact their making in process of finding new drugs and therapies.
“Making it easier for patients to access the results from trials they’ve participated in is our goal, ultimately, because that’s how it should be,” said Weingarden. “The participants are really the ones making the trials possible, they’re the ones that are putting their health and lives on the line for science, so as a general practice it’s an obligation of trial sponsors, researchers, and the research community at large to show patients what the results of a trial were and what they learned from it.”
