The current industry outlook on Plain Language Summaries

Following her panel discussion at the recent CBI Lay Summaries Conference in Philadelphia, Pooja Phogat, VP and Clinical Trial Disclosure Technical lead, shares some of the recommendations discussed at the conference.

Attended by representatives from various global pharmaceutical companies, the CBI Lay Summaries Conference offered insights on various aspects of lay summaries.

Plain Language Summaries

A divided approach to Lay Summaries

In this early phase, as the industry is gearing up to meet the regulatory requirement for lay summaries, industry leaders are divided over their approach.

While some sponsors are planning to meet the EU regulatory requirement, others are planning to ‘go above and beyond’ the regulation by creating lay summaries for participants in clinical trials beyond EU-countries.

Sponsors are also divided in their opinion on the inclusion of endpoints. Whether to report results of primary endpoints only or also to report data for all secondary endpoints. We recommend, at a minimum that sponsors include results of primary endpoints in addition to providing safety information.

As patients and the general public are the primary audience for lay summaries, sponsors should consider piloting lay summaries and engaging patients or patient representatives to gain feedback and modify their processes and templates to improve relevance for the primary audience.