Lay summaries of clinical trial results (Lay Summary)
What is meant by a lay summary in clinical trials?
Upon completion of a clinical trial for medicinal products, the trial results must be made accessible to the authorities and the public. In accordance with EU Regulation 536/2014 (Clinical Trial Regulation), the clinical trial sponsor must submit both a scientific summary of the results and a summary in a format understandable to laypersons. This requirement applies regardless of the outcome of the clinical trial.
A new element in this context is the provision of the lay summary. The background to this requirement is to increase the transparency of study results in the EU. Both trial participants and the general public should be granted access to this information.
Sponsors must upload the lay summaries to the EU database via the EU CTIS (Clinical Trial Information System) portal (see figure below).
Source: EMA
The lay summary should include, among other things, the main objectives and overall results of the trial in an easily understandable format. Annex V of EU Regulation 536/2014 lists the content requirements:
1. Identification of the clinical trial (including trial title, protocol code number, EU trial number, and other identifying numbers)
2. Name and contact details of the sponsor
3. General information on the clinical trial (including where and when the trial was conducted, main objectives of the trial, and an explanation of the reasons for conducting it)
4. Group of trial participants (including information on the actual number of individuals enrolled in the trial in the member state concerned, the Union, and third countries; breakdown by age group and gender; inclusion and exclusion criteria)
5. Investigational medicinal products used
6. Description of adverse reactions and their frequency
7. Overall results of the clinical trial
8. Comments on the outcome of the clinical trial
9. Indication as to whether further clinical trials are planned
10. Indication of where additional information can be found
When must the lay summary be submitted?
The lay summary was introduced with the implementation of EU Regulation 536/2014 (Clinical Trial Regulation) and is therefore mandatory for all completed clinical trials on medicinal products conducted under this regulation. Regardless of the trial outcome, the summary must be submitted in all member states within one year of the end of the clinical trial. For pediatric studies, it must even be available within six months of the end of the study.
What needs to be considered when creating a lay summary?
When developing a lay summary, it must be taken into account that the information is addressed to a general audience and therefore no prior knowledge of the study, medical terminology, or clinical research in general can be assumed. The layout and content must meet the needs of the general public in terms of style, language, and readability level.
A well-written lay summary is generally easily understood by young people aged 12 and above. For paediatric studies, a child-friendly version of the lay summary should be considered—meaning the presentation and style are adapted (with more illustrations or graphics) to help children understand the study results.
Patients or laypeople should be involved in reviewing the summary to assess the comprehension and value of the information. Authors with specific experience in writing in plain language for the public, who are also able to account for the scientific background and numerical comprehension, can be helpful in drafting lay summaries.
The EU Expert Group on Clinical Trials recommends providing these lay summaries in all languages of the countries where the study took place. The languages used for patient information sheets / informed consent forms serve as a guide here. Additionally, an English lay summary is recommended if it is not already included among the languages/countries. This is intended to facilitate better accessibility within the EU and globally.
Do readability tests need to be conducted for lay summaries?
By mandatory uploading of the summary to the EU portal, the relevant authorities and ethics committees are made aware of the availability of the lay summary and thus its content.
A readability check / comprehension review (readability user test) of the lay summaries by test subjects from the target population is recommended by the EU Expert Group on Clinical Trials and considered best practice. Legally, this requirement therefore falls under "soft law," meaning it reflects the expectations of the authorities, and any non-compliance should be well justified.
Where can I get support for my lay summary?
The development of lay summaries requires experience in writing for a general audience and a fundamentally different approach than writing for regulatory or scientific purposes.
The readability test identifies potential comprehension issues and subsequently determines whether resolving these issues leads to improvements.
This is a diagnostic, step-by-step process that is routinely used to evaluate the readability of package inserts for medicinal product .
Beate Beime Pharma Consulting has many years of experience in the processing and readability testing of package leaflets and can provide competent support with:
Drafting lay summaries with regard to layout and content
Conducting readability tests involving test subjects who have diverse
educational backgrounds, literacy experience, ages, and genders, and thus represent the general public.
Sources:
EU Regulation 536/2014
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
Good Lay Summary Practice Guidance