S07: Building an Innovative, Comprehensive Plain Language Summary Development Platform
Undergraduate Research Associate
USC Department of Regulatory Science United States
The objective of this project was to develop an internet-based tool that can aid researchers, particularly for those conducting investigator-initiated trials, in composing plain language clinical trial result summaries as well as to collect and analyze participant feedback and comprehension.
A prototype online platform was created that contains the necessary elements for plain language development. The prototype includes different webpages: a landing page, an about and frequently asked questions page for questions regarding plain language summaries, pages for researchers, and pages for participants. Each page supports both an English and Spanish (Latin American) language user interface. For researchers, pages were constructed to input clinical trial information to produce a plain language summary and review participant feedback. For the purpose of future improvement, feedback is solicited from researchers during the development process. For participants, pages were constructed to read summaries, provide feedback, and complete a comprehension check to determine how well participants understood the summary. For example, questions akin to “What was this study trying to answer?” were included to ensure that participants understand the objective of the research and their role within the study. Resources and content included within the prototype platform were produced considering both European Union Regulation EU 536/2014 (Article 37) stipulations for plain language summaries and plain language best practices gathered from research establishing the platform’s need.
The aim of this prototype development was to determine to what degree web development of plain language summaries could be a promising avenue moving forward — especially with many clinical trial activities going virtual due to the COVID-19 pandemic. The intent in developing this tool is to enable clinical researchers that may lack funding, time, and resources to be better able to compose plain language summaries, engage with participants, and solicit their feedback. In turn, this patient engagement could improve perceptions surrounding clinical research and clinical trial recruitment. Currently, plain language summary development among industry sponsors involves dedicated teams and adequate resources and funding for focus groups and participant outreach. Therefore, investigator initiated trials may fail to deliver comprehensible clinical trial results to participants without these dedicated teams or resources, while at the same time these trials provide an essential function in translational research. Future research would involve wider pilot program testing using this development platform to discern areas needing improvement and areas of enhanced functionality.