TrialScope Shares Findings From 2019 PLS Survey

TrialScope has released results from its 2nd Biennial Plain Language Summaries (PLS) Survey. Regulatory requirements, evolving transparency trends and patient engagement initiatives remain the top three factors driving sponsors to provide PLS.

“While the changes between 2017 and 2019 are subtle, they reflect a growing commitment to clinical trial transparency,” said Chief Strategy Officer Thomas Wicks. “When the Eudra CT portal launches next year, and more and more sponsors focus on patient engagement, we expect to see a significant uptick in the numbers of plain language summaries provided to the public.”

Wicks noted that the volume is increasing in large part due to sponsors making patient-centricity a priority. He advises that, because it takes more than a year to set up the policy and authoring of PLS, now is the time for sponsors to start the process, in advance of the EU portal and accompanying regulations.

Following are highlights from this year’s survey:

• The number of trial summaries is set to double in the coming 12 months, with up to 2,200 PLS available to patients by the end of 2020

• 95 percent of respondents either have documented processes for authoring trial results summaries or plan to create them in the future

• 57 percent distribute PLS through a multi-sponsor portal and/or a company website, or have plans to do so in the future

The survey comparisons below reflect current trends in clinical trial disclosure and transparency:

• In both 2017 (70 percent) and 2019 (83 percent), the majority of respondents said trial results summaries are important to patient engagement

• 100% of respondents are providing, or plan to provide, PLS for Phase 3 studies with 94 percent committed to Phase 2, 82 percent to Phase 4 and 77 percent to Phase 1

The 2019 results are based on responses representing a cross-section of the clinical trial industry, including sponsors, contract research organizations (CROs) and consulting service providers. TrialScope Wicks shared preliminary survey results at CBI’s Annual Medical Publications and Communications Forum recently in Philadelphia.