What is a Plain Language Protocol Synopsis (PLPS)?
Clinials were the first to use AI to generate a plain language synopsis (PLS) from a protocolCompleted in 2022, this innovation was in response to European Union Clinical Trial Regulation 536 EU which mandated that a a summary be “written in a manner that is understandable to laypersons”.
And now we have another first. Introducing the Next Evolution: The Plain Language Protocol Synopsis (PLPS) Clinials is now revolutionizing Clinical Trials with AI creating a Plain Language Protocol Synopsis (from a protocol)In the high-stakes world of clinical trials, clarity and inclusivity are essential. Clinials is breaking new ground with our AI-powered Plain Language Protocol Synopsis (PLPS), revolutionizing how stakeholders share and understand trial protocols.With PLPS, Clinials is enabling faster, clearer communication across all levels of a clinical trial. By simplifying complex protocols into easily understood language, we empower stakeholders to collaborate more effectively, reduce misunderstandings, and streamline decision-making. This innovation isn’t just about efficiency—it’s about making clinical trials more accessible and transparent, ultimately driving better outcomes for everyone involved.
Clinials’ PLPS
There is a move to have Plain language summaries a mandate worldwide. So how can we create these effectively?
In addition to its AI capabilities, Clinials is introducing a new feature that further enhances its commitment to accessibility and transparency: the Plain Language Protocol Summary (PLPS). Clinical trials are often accompanied by complex and technical documentation that can be difficult for patients and even some stakeholders to fully understand. This complexity can lead to confusion, lower participation rates, and decreased engagement.
The PLPS is designed to bridge this communication gap. By summarizing clinical trial protocols in plain, easy-to-understand language, the PLPS ensures that all participants, regardless of their medical or scientific background, can clearly comprehend the purpose, procedures, and potential benefits of the trial. This not only empowers patients to make informed decisions about their participation but also enhances trust and transparency throughout the trial process.
Clinials now makes this PLPS available during trial evaluation enabling stakeholder insights with a tool to evaluate studies efficiently before moving into planning and proposal writing.
What is the Plain language synopsis
The European Union Clinical Trials Regulation (EU CTR 536/2014) aims to harmonize rules for conducting clinical trials across the EU. It introduces procedures for trial authorization, subject protection, informed consent, and transparency requirements.
Annex 1 requests a two-page plain language protocol synopsis be uploaded during the initial trial application stage. The synopsis should include:1) Trial number and title 2) Rationale and hypotheses3) Main and secondary objectives4) Primary and secondary endpoints5) Trial design and duration6) Study population inclusion/exclusion criteria7) Interventions and background treatments 8) Ethical considerations – benefits, risks, burdens
Annex 5 outlines elements for the plain language summary of results, including trial information, participant population, investigational product, adverse reactions, overall results, outcome, indication, and additional information sources. The Good Lay Summary Practice (GLSP) guidance recommends involving patients in developing plain language summaries, but not ethics committees. Translations should be provided quickly after the source version. Separate pediatric versions can supplement the main summary. Potential benefits of plain language documents include facilitating recruitment, aiding patient-site staff discussions, and providing accessible information from the start. However, obstacles exist like tight timelines, especially for pediatric trials, and nuances between EU and UK regulations. Recommendations include getting creative with formatting, repurposing content across documents, providing a glossary page, working quickly but carefully, and leveraging efficiencies through consistency. Involving patient feedback and using readability tools can improve these documents. Approaches to avoid cherry-picking endpoints include only allowing primary endpoints, including pre-specified participant-relevant secondary endpoints, or having a standard policy on which endpoints to include. Decisions should be made early before data collection.
Why PLPS?
Business Development - Revolutionize your protocol review process: From hours to minutes
Protocol review - Revolutionize your protocol review process: From hours to minutes
Clinical trial sites - Expand your trial portfolio without expanding your team. Clinials makes it possible
Diverse Communication - Protocol summary in over 10 local languages
