Recruiting and retaining participants for clinical trials of investigational drugs has become increasingly difficult in recent years. Trial enrollment is dropping. One major reason patients cite for this dwindling participation is their lack of engagement and understanding of the clinical trial process. Why would patients volunteer their time and energy to a trial when scientific jargon makes it difficult to understand what they are signing up for, and how the results of the trial could impact their health?
What is a plain language summary (also known as a patient lay summary)?
Health Authorities are trying to combat this lack of patient engagement by passing new regulations, such as the European Clinical Trial Regulation (EU-CTR; read more about this regulation in this blog). As a first step towards informing patients, EU-CTR will require sponsors to develop Plain Language Summaries or Patient Lay Summaries (PLS) of trial results. How do sponsors ensure that patients understand their PLS? And what about other patient-facing materials, such as Informed Consent Forms (“ICFs”), drug packaging inserts, etc.?
Why not let patients and caregivers themselves review these documents and evaluate whether the content meets their needs and answers their questions? Certara makes this process simple with PODIUM: a platform to empower patient groups by including them in the creation of patient-facing content.
What is PODIUM and how does it work?
PODIUM is a secure, user-friendly electronic portal for patients, caregivers and clinicians to review patient-facing content and provide their feedback.
Certara partners with the patient advocacy group, Rare Patient Voice, to identify anonymous patient reviewers who are impacted by the specific disease addressed in a document. These patients use PODIUM to review the document and provide input and suggestions throughout. Because these patients have a vested interest in the therapeutic area and the treatment, they can provide valuable insight from their personal experiences. Sponsors can then incorporate this feedback into their final document.
At the end of the review, PODIUM participants also take a comprehension survey to assess whether they understood and retained the content of the piece. This helps sponsors evaluate whether the document met its goal, or whether it needs further adjustment before public release.
After a document has been evaluated in PODIUM, it is certified as having undergone patient review. So, Health Authorities and patients alike know that sponsors are not only meeting, but exceeding transparency requirements.
Which clinical trial documents need patient review?
Any document intended for patients would benefit from review in PODIUM. With the new EU-CTR regulations, many sponsors are focusing on the plain language summary of trial results as their main patient-facing document. However, patients also need to read and understand: Informed Consent Forms, Clinical Study Protocol Synopses, drug packaging inserts, and Plain Language Summaries of Scientific Publications (i.e., journal articles, posters, and abstracts). Any of these documents could be improved with patient, caregiver, and clinician feedback.
What benefits do sponsors and patients reap from incorporating PODIUM into their process?
Involving patients in content review creates a more robust, high-quality clinical trial document that is easier to understand. This higher level of “health literacy” may help patients feel more in control of their health. Greater health literacy also may enable patients to understand how to take their medications to maximize treatment benefits which can lead to better health outcomes.
When pharmaceutical companies adopt engagement platforms like PODIUM, patients also become more involved in their treatment, which fosters collaboration and trust with the medical and pharmaceutical community. In the long run, this will make the clinical trial and drug development process easier and more successful for sponsors and patients alike.
Contact Certara to learn more about integrating patient engagement and PODIUM into your drug development process today!