The content requirements of the Lay Summary of Clinical Trial Results are outlined in full in Annex V of the Regulation, but in contrast, the Protocol Synopsis is only mentioned in one line in Annex 1 (D.24), which states simply, “the protocol shall be accompanied by a synopsis of the protocol”. In response to requests for more guidance ...
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.
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 Providing a lay summary for all clinical trials – irrespective of ...
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. These documents are a way of sharing the results with the people who took part in the study. They may also be of interest to other people who want to know about a clinical trial.
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.
The lay summary for the final results should contain the following: Information on the clinical trial design (title, rationale, objectives, and. participants). Information on the investigational drug and trial procedures. Summary of the clinical trial’s overall results. A clear description of adverse reactions and their frequency.
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.
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 ...
The easy-to-read version of the clinical trial report is called a lay summary. This summary needs to be really understandable. According to the recommendations, lay summaries should be readable by a 12-year-old. In addition, these summaries are expected to be available in the local language of every EU country in which the study took place.
The European Commission (EC) has laid out recommendations on best practices for preparation, translation and dissemination of lay summaries of clinical trial information, intended both for trial participants and the general public, in a newly published document.
Plus, the availability of a lay summary in a patient’s native language is an important element of fair access to information, and so the translation of these documents to the local official language(s) of each of the countries affected is required. ... “In the past, when a sponsor submitted a clinical trial application, they would have the ...
Known as EU-CTR (European Union Clinical Trial Regulation 536/2014), these regulations require a Plain Language Summary (PLS) or “Lay” Summary for every clinical trial conducted in Europe. A PLS explains the trial and its results, and it’s written at a 4 th-8 th grade reading level, without scientific jargon. This new PLS requirement is ...
•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.
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 ...
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. Pharmaceutical and biotech companies publish the results of their clinical trials in peer-reviewed journals.
For teams conducting trials that incorporate decentralised, pragmatic or real-world elements, additional considerations are outlined in the draft Annex 2 of ICH E6 (R3 (.PDF)). This document updates the summary of the draft ICH E6 (R3) published on the CT Toolkit in August 2024, incorporating the latest changes from the final version.
