Lay summaries are a display of clinical study results intended for study participants and the general public. The aim of a lay summary is not only to enhance understanding of complex medical information, but also to increase transparency in clinical research. 1 This effort is supported by an increasing interest of study participants in study results and call for greater transparency. 2 ...
A PLS, also known as a Lay Summary, is a short document summarising the results of a clinical trial for people who are not scientists or medical professionals. ... Draft FDA Guidance on Provision of Plain Language Summaries. The Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard. Accessed September 13, 2023 ...
The European Clinical Trial Regulation now requires sponsors to provide a lay summary of clinical trials in a set time period following the trial end. To support sponsors, a guidance cocreated and endorsed by the European Commission aims to help implement organizational capabilities to write and share lay summaries.
Digital Curation Centre (DCC): How to Write a Lay Summary; HRA Public Involvement Guidance; Clinical trials: Summaries of Clinical Trial Results for Laypersons - 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 (2018). [N.B.
Due to new global regulations, lay summaries will soon probably become mandatory for all clinical studies. Medical writers should therefore be aware of the regulations and essential content of lay summaries. Using a case study of a published lay summary, this article discusses best practices, including the appropriate target audience, language, and
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 ...
The concept is sound – providing a simplified, easy-to-understand summary of how and why a study was done for the general public is necessary. Additionally, the Protocol Synopsis could and should form a great basis for the Lay Summary of Clinical Trial Results document, and the plain language used
Lay summaries (LSs) of scientific evidence are critical to sharing research with non-specialist audiences. This scoping review with a consultation exercise aimed to (1) Describe features of the available LS resources; (2) Summarize recommended LS characteristics and content; (3) Outline recommended processes to write a LS; and (4) Obtain stakeholder perspectives on LS characteristics and ...
The use of the clinical trial information system (CTIS) is now mandatory for all initial clinical trial applications in the European Union (EU), as of the 31st January 2023.. With this and the EU CTR, plain and lay language summaries are introduced at the start and the end of a clinical trial.. Plain Language Protocol Summary (EU CTR Annex I, D24) A plain language protocol synopsis helps any ...
•Lay Summaries are a legal requirement for all clinical trials with a trial site in the EU. •Lay summaries must be uploaded to EU portal 12 months after end of study (6 months for studies in children). •Content of the lay summaries must follow the legal requirements, should consider the available guidance, and be strictly non- promotional.
The lay summary describes a single study – there is no context of wider clinical development to enable the reader to properly evaluate the benefit-risk of the drug, and there is a danger that ambiguity in the CTR EU No 536/2014 regulation may result in similar misinterpretation. There are 10 suggested headings for the CTR lay summary; for
Pivotal studies or studies that were key for the approval of medicines; Pivotal studies for medicines where clinical development has been terminated globally. Plans are underway to expand lay summary development to include additional studies and to provide these summaries in additional languages in the future.
The European Union Clinical Trials Regulation (EU CTR) 536/2014 includes a requirement for the submission of lay summaries. Study participants, advocacy groups, and, to a lesser extent, the general public have called for greater transparency in their quest for information on clinical studies. As a c …
The new European Clinical Trials Regulation, published on 27 May 2014, requires sponsors to provide summary results of clinical trials in a format that is understandable to laypersons.
A plain language summary (PLS)—also known as a lay summary or trial results summary—is a piece of writing that briefly explains the who, what, when, where, why, and how of clinical trials. ... It plans to implement a new regulation this winter (2021/22). Known as the EU Clinical Trials Regulation (CTR) 536/2014, it will require sponsors of ...
Clinical Trial Lay Summaries – a unique chance for transparency The Clinical Trials Regulation (CTR EU No 536/2014) is directly applicable in all EU/EEA Member States and obliges clinical trial sponsors to prepare a summary of the results of every clinical trial for the non-specialist/ general public audience. Mandatory as of 31 January 2022, this […]
A brief outline of the design and results of clinical studies written using plain English is called a lay summary. These summaries (also called layperson summary, plain language summary, lay language summary, simple language summary, and trial results summary) are intended to make the clinical results of these studies understandable and accessible to patients and caregivers.
The European Union Clinical Trials Regulation (EU CTR) 536/2014 includes a requirement for the submission of lay summaries. Study participants, advocacy groups, and, to a lesser extent, the ...
