2021 Clinical Data Disclosure, Transparency and Plain Language Summaries

19 May 2021

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Monday 10 May to Wednesday 12 May

A focus of the 2021 Clinical Data Disclosure, Transparency and Plain Language Summaries virtual conference was on the forthcoming implementation of the EU Clinical Trial Regulation (EU CTR) and the launch of the Clinical Trial Information Service (CTIS).  However, the important role of different forms of plain language summaries (PLS) in sharing study information was of primary interest to us. Best practice for content development, process and dissemination of regulatory trial results summaries (TRS) was discussed, along with the evolving role of PLS, including PLS of publications (PLSP).

The EU CTR will be launched in January 2022 with study information, including on TRS, uploaded to the CTIS. Joyce Hauze (Mallinckrodt Pharmaceuticals) stressed the need to proactively involve colleagues from Patient Advocacy when drafting study protocols, to ensure that appropriate decisions are made on study endpoints in regulatory documents, which will have trickle-down effects on TRS development and other public-facing approved documents.

Approaches to improving research transparency were highlighted by Andrew George (Health Research Authority), who advocated that transparency should be:

  • easy – by making it simple for researchers to register their research
  • clear – by presenting information that is easily understood
  • accessible – by making information easily accessible for the public.

The impact of Brexit and COVID-19 on transparency and disclosure was discussed by Nirpal Virdee (Certara). It is expected that the increased collaboration with study sponsors for parallel review and approval will continue post COVID-19, with increased information sharing and joined-up initiatives having a lasting effect that will strengthen partnerships between regulators and sponsors. Emphasizing the importance of patient engagement to build trust with the public, the Medicines and Healthcare products Regulatory Agency (MHRA) is piloting placing patient engagement at the heart of clinical studies for all new active substances and new indications, in a voluntary approach that follows recommendations from the Cumberlege review. 

Oxford PharmaGenesis’ own Sarah Griffiths presented alongside Kim Edwards from the Center for Information and Study on Clinical Research Participation (CISCRP) on the use of PLSP. These are free-standing secondary manuscripts of published papers that are written for a lay audience. In the context of COVID-19, the need to build trust and transparency effectively with the public via scientific communications has never been more crucial. The speakers highlighted that people can only make an informed choice if they can both access and understand the information they are given. PLSP have the capacity to build trust and transparency via:

  • reliability – based on peer-reviewed, published content
  • clear and concise content – to meet the audiences’ health literacy needs; clarity on content supports inclusion
  • accessibility – for people to find and read easily.

Good lay summary practice recommendations from the European Forum for Good Clinical Practice will be released during the summer of 2021. Various aspects of these recommendations were a hot topic during Wednesday’s session. Thomas Schindler (Boehringer Ingelheim) concentrated on the direct and indirect dissemination of TRSs, reporting of secondary endpoints and the reporting of interim results. It is hoped that the Clinical Trials Expert Group will allow the use of multiple channels for study participants to access study results because the CTIS is difficult to access and navigate. Similarly, it is hoped that CTIS will support translations of summaries into native languages and the capability for interim results to be posted on the platform; this is of particular relevance to oncology studies, where approvals are often based on interim results and studies are of long duration, so end-of-study summaries may have limited value to participants.

An engaging panel discussion took place on secondary endpoints for TRS that build in ‘managed redundancy’, with layers of information highlighting the most patient-relevant functional endpoints. Currently a range of considerations are used, based on emerging practice, for the inclusion of secondary endpoints in TRS. Algorithms have been developed by some clients to select the appropriate level of information in a TRS, which are founded on the endpoints included in the study report and the statistical rigour with which they are analysed. It was noted that it is important to clearly differentiate primary from secondary results in any TRS, via presentation and text adaptations.

A highly informative presentation was given by Jessica Valencia of Novartis on paediatric TRS. Use of colour, graphics, diverse/identifiable characters, concise language and content based on reading age, and the need to audience-test every summary were all highlighted.

Anne-Marie Hamoir provided an update on the development of PLS guidance from Patient Focused Medicines Development, with a ‘how to’ guide being launched over the summer. Following this, a call to action was given by Iwona Bucior (Bristol Myers Squibb) to revolutionize peer-reviewed publications through the use of PLSP to communicate key findings and results in order to boost transparency and engagement; detailed methodology and results could potentially be presented within appendices. It is a novel concept that is intended to provide more concise, engaging and interactive data presentation than currently. It will be interesting to see how this rapidly evolving field may adjust and if the patient voice in publications becomes more commonplace, along with an expanded use of PLSP in driving change. Compliance barriers and a lack of guidelines were noted as challenges that require collaborative efforts to resolve.

The meeting ended with an interesting panel discussion on the role of patient authors and PLSP. To a comment about the potential for the cherry picking of studies or publications that would have PLS or PLSP developed, Hetal Patel (Boehringer Ingelheim) advised that the selection process is akin to publication planning, and it should be worked into that standard approach. As well as PLS being valued and welcomed by patients and caregivers, it was noted that they are equally utilized by specialist and non-specialist healthcare professionals. The panel acknowledged that training is required for the writers of any plain-language materials, but also for reviewers to ensure they understand the rationale for the content and intended audience; for this, internal informal education is key.

The panel was in agreement that engaging patients in document development can bring added value, should start early and should not be tokenistic. Importantly, planning is key and should also be started early because a one-size fits all approach may not always work. Above all, by improving clarity of communications, inclusion can be supported – no matter the intended audience – a maxim we at Oxford PharmaGenesis strongly believe in.