Learn how to write a clear and concise lay summary of your research for a general audience. Find guidance, examples and resources for clinical trials and other types of studies.
Retrieving ANY Patient-Focused Clinical Trial Result Summaries Through Search Strategies. When the search was extended to any patient-focused summary on individual clinical trials, a large volume of search hits was retrieved (Table 3). None of these searches yielded a clinical trial patient-focused summary within the top 50 hits.
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 Version 2. Document history: Date of discussion of the revised version by the expert group on Clinical Trials . 5 February 2018
A Plain Language Summary (PLS) is required in the European Union (EU) and European Economic Area (EAA) by the Clinical Trials Regulation (EU) No. 536/2014 (CTR). ... 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 ...
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 ): Clinical trial identification
future trials,1 and that at the end of a trial they no longer feel valued.2 Informing patients of trial results may not only provide a more positive experience for patients but also improve low clinical trial (CT) recruitment rates. EU legislation In the EU, the CT regulation (Regulation (EU) No 536/20143), stipulates that a layperson summary
Clinical Trials Ontario and Clinical Trials BC have developed a template with helpful instructions and suggested wording which is intended to be “plug and play” and easily branded by your organization. ... for lay summary of early phase dose-finding clinical trial results provides context and a template for writing a lay summary of results ...
Clinical trial summary CL3-05682-109 We would like to thank all the patients who participated in the study. As clinical study participants, they help ... This lay summary presents only results for the the main goal of the study. Other results can be found in the scientific study summary on .
Lay Summary Before and After Examples . Example 1. Lay Summary . This project comprises a focused effort to understand the evolution of prostate cancer. It will provide a detailed understanding of the molecular heterogeneity of the disease, link that heterogeneity to clinical outcome, and develop improved clinical tools for patients and clinicians.
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.
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.
Example 2: Babies born preterm have to often undergo several painful procedures after birth. Exposure of these infants to repeated pain and stress may lead to poor outcome. Sedatives provide pain and stress relief to these babies. Sedation is an important part of care for babies in the intensive care unit.
This lay summary helps the public, including trial participants, understand the results of a trial. Lay summaries will be publicly available. The EU CTR (39) specifies the requirement for a lay summary of clinical trial results. The EU CTR Q&A document, Section 6 provides further details and Annex V of the EU CTR lists the require d 10 elements ...
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 ...
• Explain how the trial will do this, over how long and with how many clinic visits etc. • Do not use ‘death’ as an outcome; where possible refer to quality of life. • Make sure your lay summary has a lay title. Language Don’t use jargon; use simple words and cut out unnecessary ones. For example: • efficacy of X – how well X works
Lay summary documents (or plain language summaries) are reports that convey clinical trial results in a simplified format for study participants and the general public [51,52].
a For example, dose ranging, safety and efficacy, placebo controlled: name and explain in plain language.. b Rather than “side effects,” the terms “adverse reactions” or “adverse events” are preferred by many trial sponsors and in the new regulations.. 3. Ready, Set, Write (in Plain Language) Writing in an approachable, conversational style can be the most creative and challenging ...
