For the first time, the European Medicines Agency (EMA) has passed new regulations to help patients understand the results of clinical trials of investigational drugs that they volunteer for. Known as EU-CTR (European Union Clinical Trial Regulation 536/2014), these regulations require a Plain Language Summary (PLS) or “Lay” Summary for every clinical trial conducted in Europe. A PLS explains the trial and its results, and it’s written at a 4th-8th grade reading level, without scientific jargon. This new PLS requirement is designed to better inform the patients we serve, thus making the drug development process more inclusive and transparent.
Many sponsors have never created a PLS before and don’t have time to read the full EU-CTR and accompanying guidances. So how do you plan for this new regulatory requirement? We’ve simplified the process into “Plain Language” for you. Here are some steps to get started.
1. Identify a Medical Writer Trained in Good Lay Summary Practice
The biggest misconception about PLS is that because they are easy to read, they should be easy to write. This couldn’t be further from the truth. The ideal PLS writer understands complex scientific source materials and is experienced in Good Lay Summary Practice (GLSP).
GLSP is an extensive guidance on how to write the most engaging, informative, and compliant PLS. It lays out ten elements to include in a PLS: trial objectives and design, patient population, description of adverse events, trial results, and more. In addition to content requirements, this guidance also provides recommendations around sentence structure, document layout, use of graphics, and inclusivity/accessibility for people of all cultures and abilities. Your PLS author should understand and implement the GLSP recommendations.
2. Consider Patient Engagement in PLS Creation
Involving patients in their health literacy drives better treatment outcomes as well as increased rates of participation in clinical trials. So, patient input and engagement in the PLS process is invaluable. After drafting your Plain Language Summary, consider having a group of patients, caregivers, and advocates provide feedback on it.
Secure patient engagement platforms like Certara’s PODIUM invite affected patient groups to anonymously review the PLS draft, provide their input, and assess their comprehension (read more about PODIUM in this blog post). These patients have a vested interest in the therapeutic area and the treatment, so they can provide comments based on their personal experiences. Involving patients in the process creates a more robust, high quality PLS, and fosters a feeling of connection and inclusion between drug developers and these important patient groups.
3. Plan for Tight Timelines
Under EU-CTR, submitting your Plain Language Summary has a difficult deadline. Most PLS must be submitted within 12 months of the protocol-defined trial completion date. Pediatric trials have an even tighter timeline; PLS for these trials must be submitted within 6 months of completion.
So how can Sponsors get ahead of these deadlines, especially while working on many competing and concurrent regulatory documents? One recommendation is to use a PLS template. A template will help maintain consistency across programs and therapeutic areas, which will be increasingly important as your company creates more PLS content. A good template will include a customizable glossary of preferred terms, so that Sponsors are always using the same easy-to-understand language for certain symptoms and events. A great template will also simplify graphic design tasks, so that this work can be done in-house, instead of waiting on an outsourced design firm to incorporate visuals. With a template, your PLS author can write the PLS shell prior to receiving the final trial results. Implementing these template tricks can save months on your PLS timeline.
4. Translate and Disseminate
In addition to uploading the final PLS to the EMA’s database, it is strongly recommended that sponsors translate and disseminate the document directly to patients. At a minimum, translate the PLS into the local official language of each country where the trial was conducted. Then, you must distribute the PLS to all trial participants through the clinical trial site, via mail or email, or through a web portal. Sponsors should research the best way to reach their patient population. Creating a great PLS is pointless if it never reaches the patients you serve!
5. Meet and Exceed Requirements
As Sponsors become familiar with trial summaries, they may want to prepare for the next levels of PLS implementation. For instance, EU-CTR suggests including a Plain Language Protocol Synopsis with your trial application. Shorter is not simpler in this case; the EMA requests winnowing your extensive protocol down to two pages or fewer. Plain Language Protocol Synopses are not yet required, but many Sponsors are piloting programs now to perfect this difficult process.
Innovative and patient-centric sponsors are also creating Plain Language Summaries of Publications. Releasing a PLS of a peer-reviewed abstract, manuscript, or poster is a great way to reach patient audiences and help them make informed decisions about their health. Peer-reviewed journals for Plain Language Publications are becoming increasingly popular, so now is the time to be on the forefront of this initiative.
Assure Compliance with Certara
Creating Plain Language Summaries requires many complex components. As an innovator in the transparency & disclosure space, Certara has authored over 200 PLS for sponsors. Contact us to learn more about integrating our experienced authors, customizable smart template, and patient engagement platform into your PLS process.
