The Growing Need for Plain Language Summaries

A growing number of countries are requiring clinical trials results disclosures in plain language summaries (PLS) that can be understood by a nonexpert. But Thomas Wicks, Head of Transparency Operations at Citeline, notes that there is also an increasing demand for protocol plain language summaries (PLPS).

“You’ve got the product dossier with the safety and efficacy sections, subject information leaflet and so on,” Wicks said. “And in the United States as well, the statistical analysis plan is due with results either as part of the protocol or as a standalone document.”

More Than Just Results Summaries

In the Regulatory Affairs Professional Society (RAPS) webcast “Navigating the Future: Trends in Plain Language Summaries and Regulatory Intelligence,” Wicks and Francine Lane, VP of Global Transparency at Citeline, discussed the latest trends in PLS and regulatory intelligence and offered insights into the increasing demands for transparency.

The takeaway from these increased PLS requirements, according to Wicks, is that sponsors need to be prepared for content from various source documents being written now to be made public in plain language at some point. This means it is worth adding plain language content into source documents like the protocol from the beginning to enable consistent reuse across patient recruitment materials, informed consent forms, trial websites, PLPS, and PLS. A lot of thought needs to go into that, he added.

For example, while PLPS are not the subject of regulation in the European Economic Area (EEA), more ethics committees are requiring them. “So it’s a de facto requirement you should expect if you’re running sites in Europe you’re providing a plain language summary, including outside of the EEA in countries like the UK and Argentina,” Wicks said.

In addition, there are industry associations suggesting their members will provide clinical trial results in an easily understood summary for the public. Members of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) have committed themselves to making these public summaries available within one year of approval, Wicks said.

IFPMA members include global pharmaceutical companies and associations including the Pharmaceutical Research and Manufacturers of America (PhRMA), the Japan Pharmaceutical Manufacturers Association (JPMA), the Association of the British Pharmaceutical Industry (ABPI), and the European Federation of Pharmaceutical Industries and Associations (EFPIA).

“Additionally, and this is just something to think about, if your organization references the Declaration of Helsinki in its ethics commitments or clinical documents, participants should be given the option of being informed about the outcome and results of the study,” Wicks said. “While that is not explicitly a plain language requirement, informing the participant can be understood to be a plain language requirement.”

Non-regulatory Requirements

Look for a PLS expert

It is necessary for those writing the disclosures to have some expertise in PLS, Wicks said. “Writing these is typically not something that medical writers have experience with. It takes a special experience, a special approach. It takes templates and standard language and there’s various tool sets and, of course, services. Our organization for example provides plain language services, writing many of these protocol and result summaries.”

Lane said PLS are intended to speak to the participants regardless of their language or reading or education level. “This is not necessarily an easy endeavor for all of those who write plain language summaries, but the idea around that is you want to speak to patients and patient advocates and the public at a level that they can understand and that builds trust,” she said. “And it also communicates what the organizations want to communicate about their trials.”

Wicks noted if sponsors prepare their protocols using plain language for certain sections, they can then reuse some of those plain language components when registering the trial on ClinicalTrials.gov. Areas where plain language is being requested include the product dossier with the safety and efficacy sections and the subject information leaflet.

Plain language can also be incorporated into the informed consent form to help participants better understand the trial procedures, risks, and benefits, Wicks said.

Another area where PLS are becoming more common is in publication, where journals are asking sponsors to provide PLS for their manuscripts. And more sponsors are committing to providing these plain language manuscript summaries (PLMS) for that use.

How to distribute PLS to participants

As PLS requirements become more common, those documents then become useful in recruiting and patient engagement materials, Wicks said. The question is how to disseminate that information.

“Traditionally it was printed, sent to sites, and then distributed [to participants],” he said. “That is very limited. It’s also expensive. Sites after a year or two or three may have lost track of the participants.

“So what we’re seeing instead is a digital dissemination of plain language summaries via web portals though these must offer a very intuitive user experience and be completely non-promotional.” He added that sponsors need to be careful of putting PLS on their corporate websites because the sites may be considered promotional in context.

Whatever portal is used should support multiple languages and be mobile compatible. “For example, our TrialSummaries.com portal supports 45 languages,” Wicks said.

It also needs to meet GDPR and HIPAA requirements. “The reason is that portals like ours allow participants to register to be informed when the plain language summaries become available,” Wicks said. “And now you have potential patient data, you have private data. So that all has to be managed properly because that can be very sensitive data. And of course you want to have some analytics around how is it being used and how is it being distributed.”

The content management platform should be simple enough that users can access the PLS easily. “You want to have it optimized for search engines so that they’re easily found. You want to be able to allow those visitors to subscribe when the plain language [summary] is available in their preferred language, because usually these PLS are now written in the language of the informed consent form.”

Sponsors need to be aware that some participants may have limited or no internet access or digital literacy. Also, elderly participants or those with visual impairments may face challenges, as may participants from diverse cultural and linguistic backgrounds. In these cases, Wicks said, alternative means of distribution through the trial sites the participants visited may be necessary. “You might provide a printed version or a conversation,” he said.

In addition, PLS could be shared through patient advocacy groups and patient portals through the healthcare providers participants are working with, as well as … links to trials on registries like ClinicalTrials.gov. “That’s something that we see fairly often,” Wicks said. “And, of course, this can be printed material, Braille, audio and video recordings. Truthfully, most companies we work with have this sort of multimodal approach.”