Layperson Summaries

What is a Layperson Summary?

Layperson Summaries (LS) are descriptions in everyday language of the design and results of clinical studies.⁵ These summaries (also called Lay Summaries, Plain Language Trial Summaries [PLTS] or Trial Results Summaries) are intended to make the clinical results of these studies understandable and accessible to participants, healthcare providers, researchers, and the general audience. The use of non-technical language and infographics, provide clear information to complex concepts and data to be more easily understandable. 

Lay summaries not only help to demystify the clinical study process, but they also provide the main results of clinical studies specifically to people with low health literacy.⁴ By giving access to study results to participants, you acknowledge patient’s participation and the value of their contribution to medical research and public health. This in turn can promote trust and enhance public engagement in clinical trials.³ 

These Lay summaries will also be a requirement for all clinical trials running in European Union(EU) soon, and it is already a requirement for some studies already running in the region. More information on the requirements can be found in the next section.

Is a Layperson Summary needed for my trial?

European Union (EU) pharmaceutical legislation known as the Clinical Trials Regulation entered into application on 31 January 2022. The EU Clinical Trial Regulation 536/2014 (EU-CTR) is replacing the European Union (EU) Clinical Trial Directive 2001/20/EC (EU-CTD) that has governed the conduct of clinical trials in the EU since 2004. The EU-CTR is designed to simplify and harmonise clinical trials in the EU, to increase transparency and safety for clinical trial participants and to restore the EU’s clinical research competitiveness.<sup>1

‍</sup>Under theRegulation, clinical trial sponsors can use the Clinical TrialsInformation System (CTIS) from 31January 2022, but are not obliged to use it immediately.¹ The transition period is 3 years, starting from 31^st of January 2022. More specifically:

• Until 30 January 2023, CTIS is optional. Sponsors can run a clinical trial under the Clinical Trials Regulation or under the Clinical Trials Directive
  
• From 31 January 2023, CTIS will be mandatory for sponsors who want to start a new clinical trial in the EU/EEA
  
• From 31 January 2025, CTIS will be mandatory for all trials, new and ongoing. Clinical trials approved under the Clinical Trials Directive and continue running will need to comply with the Clinical Trials Regulation. Sponsors must record information in CTIS.
  

After a transition period of 3 years, the submission of Layperson summaries to the CTIS will be mandatory from 31 January 2025 onwards for all clinical trials, both ongoing trials and new ones, as illustrated in the picture below. The aim of these summaries is to promote greater public awareness and understanding of clinical trials.³

For the first time, it is a mandatory requirement to provide a lay summary for all clinical trials. According to the regulation, irrespective of the outcome of a clinical trial, within one year from the end of a clinical trial (6 months for paediatric studies) in all Member States concerned, the sponsor shall submit to the EU database a plain language summary of the results of the clinical trial.² More specifically, sponsors must submit a lay summary that will then be accessible to public through the CTIS.

Why choose ClinBAY?

The creation of a Layperson summary might be time-consuming and costly. According to the guideline of Good Lay Summary Practice, to achieve the appropriate lay-level readability and graphical presentation requires special writing and design skills. For that reason, to reach optimal results, it is useful to engage experienced medical writers and graphic designers to create statistical infographics to tell the story behind your data.

Here at ClinBAY, the overall goal of our experts is to provide a visual representation of the clinical trial results to be easily understandable along with an accurate, clear and concise summary text. Our 15-year experience as Biometric CRO helps us to provide high quality Lay Summaries at a cost-effective price to our customers.

References

• EuropeanMedicines Agency. Clinical Trails Regulation.
  https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trials-regulation
  
• THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION. Regulation (EU) No536/2014 of the European Parliament and of the Council of 16 April 2014 onclinical trials on medicinal products for human use, and repealing Directive2001/20/EC (Text with EEA relevance) 2014. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014R0536
  
• EU CTR:How to write a good Lay Summary of clinical study results. EU CTR:How to write a good Lay Summary of clinical study results (clinfo.eu)
  
• Barnes A, Patrick S. Lay Summaries of Clinical Study Results: An Overview. PharmaceutMed. 2019;33(4):261-268.
  https://doi.org/10.1007/s40290-019-00285-0
  
• GoodLay Summary Practice Microsoft Word - GLSP_EudraLex_Submittedto CTEG_24Sep2021_FINAL-B4 (europa.eu)
  
• THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION. Annex V ofRegulation (EU) No 536/2014: CONTENT OF THE SUMMARY OF THE RESULTS OF THECLINICAL TRIAL FOR LAYPERSONS. 2014.