Written by Kim Edwards
On February 19, 2021, CISCRP hosted our Third Annual Plain Language Summary of Trial Results Virtual User Group Meeting. This meeting provides an opportunity for sponsors to participate in facilitated discussions about evolving or challenging aspects of developing plain language trial results summaries (referred to here as “PLS”). This year, topics included adverse events/reactions reporting, translations, dissemination, posting deadlines, and endpoint selection.
In particular, the discussion about endpoint selection was spirited. The group addressed the ongoing debate about whether it is appropriate to include secondary endpoints in PLS, and how this decision should be guided and documented. The biggest challenge with including secondary endpoints is striking a balance between providing the reader with relevant results of interest while also avoiding “cherry-picking” that leads to perception of bias. To avoid this perception, some sponsors advocate for clear guidelines across all plain language summaries within their organization. For example, some companies have created a policy to include only the results of the primary endpoint, regardless of the nature of the trial. Other sponsors suggest that this is not necessarily a patient-focused approach, as there may be secondary endpoints that are of particular interest to the trial participants.
To get a snapshot of the current practices among our User Group participants, CISCRP asked the following poll question: Does your organization have a documented endpoint selection process and/or policy for plain language summaries? Interestingly, the responses, presented in the graph below, were quite evenly distributed.
These results highlight the lack of a standard approach to endpoint selection. Later this month, we expect the release of a paper from industry stakeholders that offers suggestions on endpoint selection. In the meantime, we offer these three considerations:
- Audience – Do your trials include secondary endpoints that participant readers will care about and want to learn about?
- Cherry-picking – Can your organization implement secondary endpoint selection criteria across all trials and/or require protocol authors to indicate participant-relevant secondary endpoints prior to data collection?
- Feasibility – Will a standard approach be practical for those in your organization who must operationalize it?
We are grateful to the participating sponsors for their insights, collaboration, and dedication to providing participants with meaningful plain language trial results.