Presenting secondary endpoints in plain language clinical trial result summaries: Considerations for emerging practice

Background: The European Union Clinical Trials Regulation 536/2014 (EU CTR) requires sponsors to submit summaries of clinical trial results in plain/lay language (Plain Language Trial Summaries [PLTS]). A multidisciplinary working group developed recommendations for defining, selecting, and summarising patient-relevant secondary endpoints in the PLTS. Considerations: For sponsors who elect to include more than the primary endpoint, emerging practice is to include patient relevant secondary endpoints, defined as those that were prespecified as secondary endpoints in the protocol, their analysis being described in the protocol or statistical analysis plan, and represent something of particular importance or value to patients. The summarisation of patient-relevant secondary endpoints should reflect the statistical rigour applied to the analysis. Patient-relevant secondary endpoints should be clearly distinguished from primary endpoints in the PLTS, and they should refer to information that exists in the public domain. Conclusions: For sponsors who elect to include patient-relevant secondary endpoints in the PLTS, emerging practice is to apply a systematic approach for selection and summarisation so that meaningful information is provided to patients in a fair and balanced way