Abstract
Background:
Plain language summaries (PLSs) play a crucial role in communicating complex clinical trial information to patients and the public. Due to the European Union Clinical Trials Regulation (EU CTR) 536/2014 requirement to disclose PLSs in parallel with the technical results, clinical trial sponsors will need to develop such summaries swiftly and efficiently, while avoiding potential obstacles. Their creation can be challenging for sponsor company stakeholders who typically use highly technical, scientific language.
Brief Description of Activity:
This manuscript describes the PLS development and review process established at our company. It also considers the collection of feedback via an anonymous survey, both of which were intended to optimize PLS preparation. Finally, it explores internal stakeholder preparedness for EU CTR requirements, and further opportunities to enhance PLS quality to better support patient centricity.
Implementation:
We observed a learning curve among stakeholders (content contributors and reviewers) and an enhanced appreciation for the PLS process.
Results:
This resulted in improved best practice principles for PLS writing, such as describing only the primary endpoint(s) and adverse drug reactions. The process of PLS development was streamlined following implementation of stakeholders' feedback received in PLS surveys circulated in 2023 and 2024. This led to increased satisfaction with the instructions provided for stakeholders and with the processes for PLS development, including the company-developed PLS template and glossary of plain language terms. Here we suggest that regularly adjusting PLS tools based on continuous feedback from internal stakeholders contributes to a more efficient and clear process.
Lessons Learned:
Optimization of the PLS development process using feedback from internal stakeholders supports efficiency, clarity, and patient-centricity, as well as ensuring preparedness for EU CTR requirements.