Which endpoints to report in clinical trial lay summaries?

In November 2019 the European Commission published a question and answer document in relation to Clinical Trials Regulation 536/2014. The 103 page PDF document is available here.

The document includes one question and answer related to which endpoints should be reported in the layperson summary. The full question and answer wording from the document is pasted below, though the main thrust of the guidance is that… ‘These overall results cover the main objectives of the clinical trial and should therefore reflect at a minimum the primary endpoints, and patient relevant secondary endpoints’

6.2 Question: Which endpoints need to be summarized in the lay summary of results of a clinical trial?

Answer: According to article 37(4) of the Clinical Trials Regulation a summary of results shall be accompanied by a summary for laypersons. The summary’s content is set out in Annex V. As indicated in point 7 of the annex the overall results of the clinical trial should be given. These overall results cover the main objectives of the clinical trial and should therefore reflect at a minimum the primary endpoints, and patient relevant secondary endpoints (See also the recommendations of the expert group on clinical trials on “Summaries of Clinical Trial Results for Laypersons” February 2018 [Reference 1]).

If the trial is prematurely ended/early terminated due to lack of subjects or lack of data to analyze, sponsors have to liaise directly with the relevant National Competent Authorities confirming that no results will be available for a specific trial due to ‘lack of subjects’ or that the trial was ‘prematurely ended’ so a statistical analysis cannot be provided (EudraCT & EU-CTR Question and Answer table Q&A 56) [Reference 2]. In these cases the layperson results summary should exclude primary endpoint data points and include a statement indicating that sound statistical analysis of the information due to insufficient data was not possible.

In addition, and according to the abovementioned CT EG guidance document, where a clinical trial has had to close early, the information included in the summary should explain the reason for this, for example, evidence of lack of efficacy, safety events, poor recruitment etc. This is expected to be done in sections 3.2 (“When was this study done?”) and as a critical change to the study under 3.3. (“What was the main objective of this study?”).

References

  1. http://ec.europa.eu/health/sites/health/files/files/eudralex/vol10/2017_01_26_summaries_of_ct_results_for_laypersons.pdf
  2. https://eudract.ema.europa.eu/docs/guidance/EudraCT%20FAQ_for%20publication.pdf