When a patient has invested their time and energy into participating in a clinical trial, it’s of vital importance to provide information about the results in an easy-to-read format. CISCRP’s Health Communication Services (HCS) group specializes in the “translation” of clinical research documents into plain language to help patients understand complex clinical trial information. Among the most common of these is the trial results summary. With the impending implementation of EU CTR (536/2014) and as sponsors increasingly recognize the importance of patient engagement, many companies are beginning to prioritize the development of these summaries, sometimes referred to as “lay language summaries.” These documents play a critical role in the effort to keep patients and the public informed about clinical research and demystify the process.
Producing a plain language trial results summary is a multi-step process. The first phase is the development of a robust summary template that can be customized from study to study. This template is structured to be in alignment with a sponsor or CRO’s company requirements and preferences. The template should also meet EU CTR requirements and plain language best practices. To keep templates up to date and incorporate lessons learned, we update both the CISCRP template and our clients’ customized templates annually.
When creating content, a patient-centric focus is key. Summaries are most effective when written at a 6th to 8th grade reading level and it is vital that the content be unbiased, clearly written and easy-to-understand. During the development process, CISCRP’s volunteer Editorial Panel members, consisting of patients, members of the public, health professionals and patient advocates, have two opportunities to review and comment on internally created documents, to ensure readability and scientific accuracy.
Sponsors who wish to draft their own summaries may opt to utilize our Editorial Panel Review only. In practice with this model, CISCRP only performs an editorial review of the first draft and provides feedback regarding plain language best practices and EU CTR requirements. This may also include the implementation of requested graphic design elements. As needed, CISCRP and the sponsor project team meet to discuss suggested revisions. The modified draft is reviewed by the Editorial Panel where their valuable feedback helps inform any further revisions that may improve the readability of the summary. These suggestions are shared with the sponsor team and offers the opportunity for further discussion and comment resolution.
Some sponsors prefer to pilot their initial summaries using the Editorial Panel Review only approach. This allows them to utilize CISCRP’s plain language expertise and volunteers, while still “owning” the writing and stylistic elements of the summary. Since 2018, CISCRP has collaborated with UCB Biopharma SPRL and other organizations, finalizing several summaries that are now electronically available to patients and the public.
Engaging our plain-language trained staff to assume a more active project management role gives valuable time back to the an organization’s internal medical writers and creates efficiencies by allowing the writer and editor to communicate more directly.
Producing patient-facing collateral that is transparent and direct is an essential part of the conduct of clinical research. Learn more about CISCRP’s patient engagement and education materials.