A plain language summary of study results for laypersons is a simplified and accessible report of the findings from a clinical trial. It is written in clear, non-technical language to ensure that individuals without a scientific or medical background can understand the outcomes and implications of the study.
Regulatory requirements
Regulatory mandates exist for providing a summary of clinical trial results in a format understandable to laypersons. These mandates enhance transparency and ensure that trial participants and the public can access and comprehend the results of clinical studies
EU
The Clinical Trials Regulation 536/2014 (Article 37) requires sponsors to present clinical trial results in a format that laypersons can easily understand.
Summary of the results of the clinical trial for laypersons
This summary typically includes following elements (CTR 536/2014, Annex V [1]):
- Clinical trial identification
- Name and contact details of the sponsor
- General information about the clinical trial
- Population of subjects
- Investigational medicinal products used
- Description of adverse reactions and their frequency
- Overall results of the clinical trial
- Comments on the outcome of the clinical trial
- Indication if follow up clinical trials are foreseen
- Indication where additional information could be found
US
While not as explicitly mandated for lay summaries as in the EU, the US government encourages the dissemination of clinical trial results to the public, including lay summaries. One of the regulations, “Clinical Trials Registration and Results Information Submission” (42 CFR Part 11 [2]), requires sponsors to submit trial results to the ClinicalTrials.gov database, which includes elements understandable to the public.
The World Health Organization (WHO)
The WHO also advocates for the reporting of clinical trial results, including lay summaries, to ensure transparency and public trust in clinical research. WHO outlines its requirements for the reporting of clinical trial results, including lay summaries, in its “Joint Statement on Public Disclosure of Results from Clinical Trials” [3].
See also
Another relevant pages
Links to this page
References
- ↑ Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014, https://eur-lex.europa.eu/eli/reg/2014/536/2022-12-05 Accessed Jul 2024
- ↑ 42 CFR Part 11, https://www.ecfr.gov/current/title-42/part-11 Accessed Jul 2024
- ↑ WHO, 2017, Joint statement on public disclosure of results from clinical trials, https://www.who.int/news/item/18-05-2017-joint-statement-on-registration Accessed Jul 2024
External links
- European Commission, 2017, Recommendations of the expert group on clinical trials for the implementation of Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use: Summaries of Clinical Trial Results for Laypersons, https://health.ec.europa.eu/system/files/2020-02/2017_01_26_summaries_of_ct_results_for_laypersons_0.pdf Accessed Jul 2024
- Health Research Authority (HRA), 2024, Writing a plain language (lay) summary of your research findings, https://www.hra.nhs.uk/planning-and-improving-research/best-practice/writing-plain-language-lay-summary-your-research-findings/ Accessed Jul 2024
- ClinicalTrials.gov, 2024, Plain Language Guide to Write a Brief Summary, https://clinicaltrials.gov/submit-studies/prs-help/plain-language-guide-write-brief-summary Accessed Jul 2024