CISCRP has been working with sponsors since 2010 to produce plain-language clinical trial summaries. As we continue to optimize our plain-language services, we’ve not only explored new ways to improve the summaries; we’ve also applied the same plain-language principles to other patient-facing documents, helping sponsors apply these concepts more broadly.
CISCRP was most recently selected to work with SWOG Cancer Research Network, one of the National Cancer Institute’s National Clinical Trial Network (NCTN) groups, with funding from The Hope Foundation for Cancer Research. CISCRP will work with SWOG and other NCTN network staff and patient advocates to create a plain language template for clinical trial summaries. The template will be available for use by the NCTN groups to ensure National Cancer Institute funded clinical trials are more accessible to patients and caregivers. This work mirrors the early Trial Results Summaries template work we started in 2010, and we were honored to have our expertise recognized with this grant.
CISCRP has also expanded its Communicating Trial Results work to include translating informed consent forms into plain language. The goal here is to achieve an informed consent process that respects and educates adults, children, and teens that are asked to participate in clinical studies, as well as their caregivers. CISCRP works with sponsors to ensure that ICFs are written in plain language and are designed for optimal engagement and understanding. Applying design elements in the template aims at creating a user-friendly document that the sponsor’s clinical teams can easily utilize.
CISCRP has collaborated with multiple sponsors on such ICF initiatives. Feedback from our internal experts in health communication best practices combined with that of our editorial panelists (patients, patient advocates, members of the public, and health care professionals) helps to ensure the ICF is free of confusing medical terminology and unfamiliar technical terms. In one project, for example, CISCRP converted a broad glossary of terms and terminology to plain language that could be incorporated into the ICF. The sponsor’s clinical teams then tested the plain language versions of the ICF template and glossary with a sample protocol, to ensure that both components were easy to use. CISCRP then tested this sample ICF with an Editorial Panel to ensure the “final” version was understandable.
As with all of our plain-language projects, CISCRP focuses on the following areas when developing an ICF template:
- Clarity of content, identifying specific elements that require simplification for the intended audience. Attention will be given not only to reading level, but also to health literacy, graph literacy, numeracy, and related considerations.
- Appropriateness of information density, helping to ensure content neither overwhelms readers (e.g., too many new concepts introduced together), nor appears to be hiding or holding back important information.
- Overall design, with special attention to whether the structure is clear and inviting and is likely to enhance comprehension and ability to quickly locate the most relevant information.
- Fair and balanced presentation, considering whether any content presents as too positive or too negative, incomplete in an important way, or inaccurate. Consideration will also be given to whether the content is sufficiently sensitive to the likely needs, experiences and expectations of the intended audience.
Through CISCRP’s work with multiple sponsors, we have learned that it’s important not only to create an ICF template in plain and understandable language, but also to consider the graphic design. Is the document visually appealing? Does it include appropriate use of white space, and icons to aid in understanding? These are key considerations, but further, CISCRP suggests that ideally, all sponsor companies consider not only translating their ICF into plain language, but also developing a glossary of terms. This would help clinical teams to choose appropriate language, rather than plugging medical jargon into an otherwise plain language-friendly template.
Written by Jill McNair, Senior Director of Patient Engagement