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 to demystify the process.
Producing a plain language trial results summary is a multi-step process. At CISCRP, the first step is the development of a robust summary template that can be customized from study to study. The CISCRP template is structured to meet EU CTR requirements and incorporate plain language best practices. Yet, it is flexible enough that it can be structured to align with a sponsor’s company requirements and preferences. To keep templates up to date and incorporate lessons learned, CISCRP updates our own 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 engages volunteer Editorial Panel members to review and comment on a draft of the summary to ensure readability. These panels consist of members of the public (whether or not they are patients), health professionals, and patient advocates. Their feedback is crucial to ensuring that the summary is understandable and strikes the proper tone.
Sponsors working with CISCRP have their option of two different service models: full-service, or Editorial Review only. In the latter model, the sponsor writes the summary and engages CISCRP to perform an editorial review of the draft. This includes feedback regarding plain language best practices and EU CTR requirements. This may also include the implementation of requested graphic design elements.
Some sponsors prefer to pilot their initial summaries using the Editorial 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.
The full-service model, however, engages our plain-language trained staff to assume a more active project management role. This gives valuable time back to an organization’s internal medical writers and creates efficiencies by allowing the writer and editor to communicate more directly. In the full-service model, CISCRP is responsible for the authoring, plain-language editing, content and editorial QC, and graphic design of the summaries. The sponsor has two opportunities to review and comment on the document to ensure it is scientifically accurate. This approach allows each party to focus on their respective areas of expertise, collaborating to produce a document that is plain language friendly and informative.
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.