Implementing “Good Lay Summary Practice”

2022 marks the start of a new era in clinical trials in Europe with the implementation of EU Clinical Trials Regulation (CTR) and Clinical Trials Information System (CTIS) going live on 31 January 2022. Significant new rules have come into effect alongside a series of non-legislative initiatives, bringing the hope of more efficient processes and greater patient benefit. Crucially, the new EU CTR has a focus on increasing transparency and creating new opportunities for patient engagement, notably in requiring trial sponsors to publish their results in lay summaries – documents purpose-built to be accessible to everyone. The challenge in making lay summaries available to patients and the public – with their simultaneous demands for readability and rigorous accuracy - was the subject of a multi-stakeholder workshop in February 2022, organised by EFPIA and EFGCP, and featuring input from patients, sponsors (industry and academia), and EU representatives (European Medicines Agency and European Commission).

Although many trial sponsors have been routinely producing reports aimed at non-professional audiences, this is the first time Europe has created a legal requirement – and associated rules - to inform patients and the public about each clinical trial in a manner which is easily understandable. As DG Santé put it at the meeting, "CTR is introducing stronger organisation and coordination across Europe for the assessment and oversight of clinical trials – with an increase in transparency." Representatives underlined how the policy environment in Europe is switching towards patient focus and engagement, and transparency.

The new requirement for lay summaries is much more than a long-overdue courtesy to trial participants, who obviously deserve clear information about how far their engagement has contributed to the advancement of science. It is also much more than an avenue for satisfying incidental curiosity about the development of a medicine or a treatment. What the systematic provision of these summaries amounts to is new and a necessary tool for developing and reinforcing the trust on which health research depends. Reliable and accessible information geared to a broad audience becomes a mechanism for dispelling public concerns that trials are part of an opaque black-box procedure. The impartiality implicit in these summaries offers the public and patients an unprecedented chance to understand what's going on in research, and gives researchers a channel to better communicate results. As DG Santé conveys, supporting public confidence in clinical trial processes has a positive effect in the overall EU regulatory system for medicines. More systematic public disclosure of the aims and outcomes of individual trials is breeding public confidence, contributing in turn to a more conducive environment for continued research.

While the concept is simple, its implementation is far less evident. The intrinsic challenges of combining readability and scientific rigour are undeniable, and the administrative aspects of planning, producing, translating and disseminating these reports are complex and potentially onerous. Inadequate compliance would be counterproductive insofar as it would risk destroying the very trust that the system is designed to consolidate. Inefficient compliance would make the processes so costly and time-consuming as to imperil diligent observance of the requirement. That is why a broad range of stakeholders have recognized the need for guidance on the implementation of GLSP, and are working towards refining it.

This workshop was a crucial link in that process, and a natural extension of the work that has preceded it. While the legislation lays down regulatory provisions for Lay Summaries (LS), and the guideline fills out many of the principles, effective implementation will require a clear understanding of each of the detailed tasks and processes necessary to attain the goal of improved understanding among patients and public. That is why, as the new legislation has come into effect in January 2022, a wide range of stakeholders – from authorities, sponsors (industry and academia), patients and civil society - are collaborating to explore how they can best deliver on this new responsibility, through a concept known as Good Lay Summary Practice.