Clinical Trials in Plain English: TrialAssure Translates for Patients

Xconomy Detroit/Ann Arbor — 

Software is playing a growing role in clinical trials, and over the years it’s been introduced as a tool to help enroll patients, collect data, and analyze results. But one aspect of clinical trial record-keeping has been stubbornly stuck on paper—the reporting of data to the patients who volunteer for the studies.

TrialAssure, a Canton, MI-based company developing software tools to increase the transparency of clinical trials, has launched a new website called TrialResults that enables the companies that conduct these studies to share plain-language trial summaries with the participating patients.

Zach Weingarden, TrialAssure’s product solutions manager, says the online portal allows clinical trial participants to read lay summaries of the trial’s results in English, or whatever their native language is. It replaces the typical process of mailing paper copies of summaries to patients, he adds. Some of the larger trial sponsors—the biotech and pharmaceutical companies that are running the studies to test their drugs–will post summaries of results on their own websites, but he maintains that small and mid-size companies often don’t have the resources to do that in-house.

“That’s where TrialResults fits an unmet need,” Weingarden says, noting that some clinical studies take years to complete, making it harder to track patients down when it’s time to deliver a summary. “Trial participants put their health on the line to contribute to science. Having one document uploaded for everybody to read makes the logistical challenge easier.”

Sponsors pay TrialAssure a subscription fee to post summaries, but patients can access them free of charge. Weingarden says contract research organizations, pharma companies, and other sponsors upload plain-language trial summaries onto the portal. Participants enter an already-provided unique trial identifier to access the information. Sponsors can also send participants a link to the URL containing the summary. In addition to the data of an individual patient, the summaries often include broader, anonymized data about the overall study.

The company says only 2 percent of clinical trial sponsors have issued lay summaries to participants in the past few years, according to a report by Applied Clinical Trials. Trying to parse dozens of pages of jargon-filled summaries posted on government registries can be a challenge for many patients, Weingarden says. At TrialResults, they’ll find that information distilled into a few pages written at an eighth-grade level and often containing graphics.

Weingarden says that TrialAssure was born out of a partnership with MMS, a Canton contract research organization, about a decade ago. The 30-person software-as-a-service company provides a suite of tools that anonymize trial participant data so it can be shared publicly or with other researchers, and help to manage trial compliance and disclosure.

TrialAssure’s ultimate goal, Weingarden continues, is to create a collaborative platform and rich repository of information that people can search by condition, date, geography, or other parameters. “If they can find it all in one place, it could be a powerful tool for patients,” he says.