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Plain Language Summaries and Patient Engagement: Paving the Way

By Theresa Shalaby, MSN, RN

Engaging the patient is key to support clinical trial recruitment and have truly patient-centric drug development. Writing for patients and the general public is vastly different from writing for regulatory authorities or clinicians. Plain language summaries (PLS) of clinical trial results ensure that study participants are informed about study results and that they understand the value of their contribution to science and public health.

It is expected that by December 2021, pharmaceutical companies will be required to develop PLS for the results of all clinical trials with participants in the European Union for the public. Thus, the biopharmaceutical industry is seeking expertise not only in the authoring of PLS, but also in the challenge of patient engagement.  The goal of patient engagement is to enable patients, care givers, and clinicians to provide input during the development of PLS.

To answer this challenge, Synchrogenix, a Certara company, has developed a secure, user-friendly electronic patient portal called Podium, which enables patients, care givers, and clinicians to review and make suggestions for improvement of PLS from their perspective. Within Podium, the reviewers also provide feedback on their level of understanding of PLS.

For each PLS, anonymous reviewers are invited to Podium via the patient-advocacy group Rare Patient Voice (RPV), which partnered with us in this endeavor. RPV provides reviewers who are impacted by the disease that is the subject of the clinical trial and PLS.  

Together, Synchrogenix and RPV have established a successful process for patient engagement, while demonstrating that the reviewers have a high level of understanding of the PLSs reviewed.

To date, of the 45 patients, care givers, and clinicians who completed PLS reviews in Podium, 100% stated that they understood the PLS they reviewed.  All  of them also correctly described the purpose of the clinical trial that was the subject of the PLS, which validated their affirmative statement of understanding. 

Moreover, on a scale of 0-5, with 0 indicating no understanding of the PLS, and 5 indicating a high level of understanding, the average level of understanding among the 45 reviewers was 4.3.

The development of Podium and the collaboration with RPV clearly demonstrates that not only is robust patient engagement in the PLS space possible, but that it empowers patients and provides valuable feedback to clients and PLS authors.

But you don’t have to take my word for it. Here are what people are saying about this solution:

“Patients want to learn everything they can about their health.  Unfortunately, much of the available literature is so complex that is not usable for patients.  Synchrogenix is working with Rare Patient Voice patients to incorporate their voices into clinical trial summaries.  This is a wonderful way to ensure that important scientific data is available to patients in a clear and understandable format.” 

Pam Cusick, Vice President, Business Development, Rare Patient Voice

“I felt like everything was easy to understand and had the right amount of detail for readers to clearly understand without feeling overwhelmed.”

Anonymous patient reviewer

“It was a good summary, not confusing.”

Anonymous patient reviewer

“Yay, this answers my [drug] comparison questions!”

Anonymous patient reviewer

“Despite the multiple treatment groups involved, the summary was able to focus on the more pertinent study results.”

Anonymous patient reviewer

To learn more about how we’re supporting transparency and disclosure requirements for clinical trial data, please visit our Transparency and Disclosure Technology and Services webpage.

About the author

Theresa Shalaby, MSN, RN
By: Theresa Shalaby, MSN, RN
Ms. Shalaby has over 30 years of experience in the clinical research and drug development industry. Throughout that time,, she held several writing roles including lead author and contributing writer for investigator’s brochures (IBs), phase 2 and phase 3 clinical study reports (CSRs), investigational new drug applications (INDs), new drug applications (NDAs), study protocols, informed consent forms (ICFs), and plain language summaries (PLS). She has experience in the therapeutic areas of pediatrics, neonatology, pediatric and adult oncology, hematology, gastroenterology, pulmonary and respiratory diseases, genetic diseases, cardiology, multiple sclerosis, and rare diseases. She is the functional lead for PLS at Certara Synchrogenix.

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