Best Practices Guide to Clinical Trial Lay Summaries
Lay summaries are easy-to-understand briefs for complicated, technical clinical trials, and health information. Patients and anyone with an interest can access the results regardless of background, reading level, and age. Pharmaceutical companies and contract research organizations (CROs) looking to translate their clinical trial results are advised to adhere to the new EMA Regulation (EU-CTR) No 536/2014 following the European Union (EU) clinical trial sponsors handbook, Good Lay Summary Practice (GLSP).
The GLSP handbook includes recommendations on preparing, writing, translating, and disseminating clinical trial results via summaries in lay language.
Continue reading to learn more about the GLSP handbook and how you can ensure compliance with this latest regulation.
Good Lay Summary Practice Handbook Overview
The application of the clinical trials regulation (Regulation (EU-CTR) No 536/2014) on January 31, 2022, will lead to major changes in the current methods of conducting clinical trials in the EU.
The regulation integrates the supervision and assessment processes for clinical trials across the EU through a Clinical Trials Information System or CTIS.
The CTIS contains the centralized EU database and portal for clinical trials the regulation foresees. In collaboration with the European Commission and the Member States, the European Medicines Agency (EMA) is responsible for organizing and maintaining the CTIS.
The regulation’s application will repeal the current EU Clinical Trials Directive (EC) No. 2001/20/EC, including the national legislation used to implement the directive. This also applies to trials authorized under the previous legislation, provided they are ongoing three years after the regulation was applied.
Member States will still be responsible for overseeing and authorizing clinical trials, while the EMA manages the CTIS and supervises publishing content on the public website, following transparency rules, unless additional exemptions apply in order to protect personal data and confidential communication. Essentially, CTIS provides one entry point for submitting clinical trial data within the EU, which gets stored in the system.
Under the new clinical trial regulation, there are two additional sets of requirements implemented by the EMA. These requirements apply to the functional specification for disclosure exceptions:
- Features that support making information public and,
- Disclosure rules that describe the practical implementation of the transparency rules.
The GLSP Handbook
The Good Lay Summary Practice (GLSP) handbook, released during October 2021, provides recommendations to help pharmaceutical companies and CROs prepare, create, translate, and disseminate clinical trial results summaries in plain language.
Essentially, the GLSP handbook provides practical advice and best practices for implementing lay summary guidelines for comprehension.
Creating lay summaries addresses the mandatory requirement under Regulation (EU-CTR) No. 536/2014 of the European Parliament and the Council of April 16, 2014, on medicinal products for human use clinical trials.
Lay summaries also promote transparency for all trial participants and the general public.
The GLSP handbook generally recommends organizing your lay summary process in four stages: planning, development, translation, and dissemination.
Translations are a Key Part of the Good Lay Summaries Practice Process
Translations are recommended by the EU Expert Group on Clinical Trials. At a minimum, the Lay Summary should be provided in the local language(s) of each of the countries where the trial takes place. The GLSP handbook outlines two additional (optional) steps highlighting the practice process for translation: back translation and equivalency or comparative review.
Below is a quick breakdown of the step-by-step translation process recommended by the GLSP handbook, including the two optional steps.
- Planning. The source file (or master lay summary or LS) needs to be analyzed prior to initiating the translation process. This is crucial to identify biased language, potential risk areas of regulatory compliance, and ambiguity. Translation planning can also help establish everything, including checklists, specific instructions, glossaries, and the necessary tools or reviews for the translation process.
- Forward translation. This refers to translating a source text (the master LS) into a target language (or languages).
- Back translation (optional). Back translation is translating a target text (the forward translation results) into the original source language (the same language as the master LS). This quality control step is designed to reveal language drifts or discrepancies from the translation process.
- Comparative review (optional). This step requires a third resource to perform a comparative review between the back-translated and master LS to spot and examine the source and translation discrepancies. The comparative review stage is where the forward translation can be revised to resolve issues and get to the most faithful translation of the LS.
- Final quality assurance inspection. Run a final and thorough inspection after including the desktop publishing and other production quality steps for the final file.
- Delivery and certification. The final output is the translated LS, including translation certificates (if the sponsor wants to work with a language service provider and get translation certification).
Language, and in turn, lay summary translation, is often a complex process. It requires expertise, proper planning, and control to help minimize potentially poor, inaccurate, and costly outcomes.
As such, the GLSP handbook recommends considering budget implications, including factoring in the costs associated with translation at the proposal stage.
Remain Compliant with Clinical Trial Lay Summary Updates
A huge part of clinical trial lay summary regulations compliance is ensuring a high-quality and accurate translation process.
That’s where Welocalize comes in.
We are well-positioned to service lay summaries because we have a unique, tried, and tested workflow that ensures comprehension. Our centralized process, besides giving you full transparency, includes not only the 2 additional suggested steps, but adds a Final Read to ensure the readability level is suitable for the final output of the translated lay summary.
Get in touch with us for advice or more information, to ensure your lay summaries are fully compliant with the new EMA regulation.