Patient Engagement and Multi-stakeholder Collaborations
World Alliance for Pituitary Organizations
ay language summaries—sisters to Plain Language Summaries—focus on summarizing clinical trial results in an understandable way to provide increased transparency to the patients and interested general public. The European Clinical Trial Regulation now requires sponsors to provide a lay summary of clinical trials in a set time period following the trial end. To support sponsors, a guidance cocreated and endorsed by the European Commission aims to help implement organizational capabilities to write and share lay summaries.
Since 2014 when the European Union (EU) Clinical Trials Regulation (CTR) No 536/2014 was released, sponsors have had to provide LS results of clinical trials to increase clinical trial transparency, although this requirement came fully into effect only in January of this year (EMA 2021, EUR-Lex 2014, EU 2014). This LS is required to be done in a format understandable to laypersons and the public at large. This dissemination is facilitated by the European Medicines Agency’s (EMA) Clinical Trials Information System (CTIS) that was launched at the end of January 2022. Sponsors are required to submit a LS (Annex V of the CTR) and a technical summary (Annex IV of the CTR) of the results of all new Phase I through IV interventional clinical trials.
For clinical trials in adults, sponsors will be required to post a LS and a technical summary within 12 months of the end of the trial, up to 30 months for nontherapeutic Phase 1 trials and 6 months for pediatric trials. Implementation of the CTR will go through a 3-year phase-in. In the first year, LS submission will be optional, while after the second and third years, it will become mandatory for new trials.
What Are the Main Components of a Lay Summary?
The EU CTR Annex V lists the 10 key elements that must be included in the LS, i.e., the clinical trial identification, name and contact details of the sponsor, general information about the trial, trial population, investigational medicinal products used, description of adverse reactions and their frequency, overall results of the trial, comments on the outcome of the trial, indication if follow-up clinical trials are foreseen, and indication where additional information can be found.
Lay Summaries as the Connecting Factor Between Stakeholders
The availability of a LS at the end of the clinical trial process provides not only closure, but also valuable information that may change the course of a participant’s disease journey. Summaries cocreated and/or reviewed by the patient community help to ensure that the LS focuses on or includes information that is important to the community.
Patient involvement and engagement initiatives, including cocreation and dissemination of LSs, may also increase participant recruitment and retention in clinical trials. Healthcare professionals may also find LSs extremely valuable for communicating current clinical findings of a particular treatment option to their patients.
Several tools and guidance documents have been created to lower the barrier for creating PLSs. Some examples include:
- Patient Focused Medicines Development’s (PFMD) PLS How-to guide aims to increase the collaboration between industry and patient community to cocreate/coauthor PLSs
- Future Science Group’s Plain Language Summaries tool aims to help authors publish LSs
Many countries in which LSs for clinical trials are not yet explicitly required, such as the US, have nonetheless shown awareness of and support for LS development. Moreover, companies which are used to operating globally have already started sharing results with their trial participants, through the investigators and/or specific websites.
Cocreated Guidance to Set up Organizational Lay Summary Capabilities
