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The Importance of Plain Language Communication in Clinical Research

A Q&A session with EFGCP Chairman of the Board, Ingrid Klingmann

This is part of our Patient Engagement series, where Lionbridge Life Sciences experts discuss the history and current status of participants in clinical studies and patients in the healthcare system.

In 2021, Lionbridge became a Corporate Member of the European Forum for Good Clinical Practice (EFGCP) due to our dedication to transparent and accessible communication across the life sciences industry and patient communities.

Recently, Pia Windelov, Lionbridge’s Sr. Director of Regulated Life Sciences Solutions Portfolio, interviewed Ingrid Klingmann, Chairman of the Board of EFGCP.

In this Q&A, we focus on the importance of communication and plain language within clinical research for an assortment of stakeholders in the healthcare sector.

Pia: Welcome Ingrid; thank you very much for being here. At Lionbridge, we are excited about our partnership with EFGCP because we have a shared passion for implementing transparent, effective communication across patient groups, life science industry, ethics committees, and regulators. You and I have already had the pleasure of working together on the Roadmap Initiative to Good Lay Summary Practice (GLSP). Under EFGCP and EFPIA leadership, we developed multi-stakeholder recommendations on how to develop lay language summaries of clinical trial results under the new EU Clinical Trial Regulation. On October 4, the GLSP was published on EudraLex - Volume 10 as a clinical trials guideline adopted by the Clinical Trials Expert Group under the European Commission.

Can you describe how you envision EFGCP’s role and mission when it comes to results communication and transparency across clinical research, regulators and patient communities?

Ingrid: Transparency on clinical trial results will only be meaningfully improved if Lay Summary production and dissemination are practically feasible. Both patients and the public need to be able to easily find and understand the information. In response to consensus about the need for a concrete global infrastructure for patient-centric Lay Summary preparation and dissemination, over 60 organisations joined forces in the “Roadmap Initiative to Good Lay Summary Practice” (GLSP). Collectively, the group represents all involved stakeholders.

It started with collecting and discussing existing Lay Summary expertise. Then, we jointly developed the most suitable approaches to be presented in a Quick Guide and Handbook, facilitating what will become a legal requirement with start of the Clinical Trial Regulation on January 31, 2022. In collaboration with the European Commission’s Directorate Santé “Expert Group on Clinical Trials” (CTEG), these recommendations have now become an element of the regulatory framework for clinical trials presented in EudraLex Volume 10.

This was only the first step towards enabling reliable transparency on clinical trial results. Equally important will be the introduction of these recommendations into the work processes of industry and academic sponsors and the patient engagement community.

The Roadmap Initiative member organisations also decided to go into the dissemination phase jointly under the leadership of EFGCP and EFPIA. This means that we will create and execute a work plan for raising as broad as possible awareness of the new standard. We will organise webinars and workshops for the general public and individual stakeholder groups to discuss GLSP implementation, possible challenges and areas of further improvement. And we will develop training programs focusing on the needs of the different stakeholders. With support from our colleagues in the U.S., we hope to initiate a quantum leap in clinical trial result transparency.

PW: Lionbridge is a language services and technology provider, and our clients often look to us for compliance and industry guidance on language requirements under the new EU reforms on clinical trials (EU CTR) and medical devices (EU MDR and EU IVDR). I believe they ask us due to a general lack of guidance from regulators and because language remains a national matter determined by each individual EU Member State. Do you think we will see more guidance or standards from regulators that can help industry in the development and dissemination of plain language communication?

IK: Access to information in national language is an EU Member State responsibility. It is unlikely that attempts will be made by the EU Commission to regulate this area beyond the approach presented in the GLSP: if decisions need to be made like joining a clinical trial, the information (in the Patient Information Sheet) needs to be provided in a language the patient can understand and therefore, information on the results should be available in the same languages.

A close-up of a medical provider reviewing someone's chart.

PW: What are some of the challenges you see in creating effective and non-promotional communication of clinical trial results and medical device performance to trial participants and the general public? This question must be relevant across the healthcare ecosystem due to the upcoming EU databases for clinical trials and medical devices which are being established as part of the new regulatory EU reforms.

IK: While we can and have come to agreed standards for content of the Lay Summaries and their development, we worry whether the Lay Summaries reach patients and the public. Upload into the EU Database is legally required for trials with medicines, respectively medical devices. However, there is no defined location for result summaries from all other types of clinical studies, and we are not sure that patients and the public will proactively try to search for results from medicines and device trials in these complicated EU databases.

Another challenge is the short preparation period foreseen by the new legislation. This will make it very difficult to prepare Lay Summaries that are fully fit for purpose. Ideally, Lay Summaries should have patient involvement in their development, as well as professional user testing of the master version and translations.

A third point concerns the content: The Lay Summary should present the results from the primary research question and from patient-relevant secondary objectives. But how do we define “patient-relevant”? This ambiguity leaves room for “cherry-picking” presentations of favourable results. Our GLSP recommendations give advice on how to avoid this, but there is no guarantee that sponsors will reliably apply those recommendations.

"GLSP recommends that trial sponsors start planning the Lay Summary and its translations before study start and at the time of preparation of the trial protocol and Patient Information Sheet/Informed Consent Form."

PW: It is generally acknowledged that communication to plain language or non-scientific audiences such as trial participants, patients and the general public is most effective in local or native language. However, as a language services provider, Lionbridge often comes across clients that manage translations as a last-minute undertaking and with limited budget allocations or funding. Do you see this approach changing in the future, given the increasing focus on transparency and results communication under the new regulatory reforms in EU for clinical trials and medical devices?

IK: I am afraid that this will remain an issue for quite some time. GLSP recommends that trial sponsors start planning the Lay Summary and its translations before study start and at the time of preparation of the trial protocol and Patient Information Sheet/Informed Consent Form. This is to ensure upfront agreement on how to present the results and to use the same language approach in the Patient Information Sheet and in the Lay Summary. Such early planning will be helpful in managing the very short regulatory timelines for results disclosure after trial completion. But it is also a matter of budget: Early planning should protect budget for the Lay Summary and its translations. Especially in publicly funded trials this will be a challenge because the Lay Summary preparation and dissemination may occur well after the end of the funding period. The current funding schemes do not foresee funding of project activities after the end of the project period.

PW: As chairman of the board of the EFGCP, you interact closely with regulators, industry, academic institutions and patient groups. Where do you see progress, and conversely, obstacles, across these different stakeholders in creating transparent communication? How do you think plain language communication will evolve over the coming years?

IK: Large pharma companies have already established the process of developing Lay Summaries for results from clinical trials in adults, much less though for results from paediatric trials. But smaller companies and academic researchers will practically have to start from scratch. They have very limited experience and resources for preparation, translation and dissemination of Lay Summaries.

One of the key elements of GLSP is the involvement of patients into the development, translation and dissemination process. This aspect is difficult to achieve in the very squeezed preparation timeframe and without budget. The legal requirement for creating and disseminating patient-centric Lay Summaries is a very good reason for raising awareness about the need and especially the benefits of reliable result transparency but it will require a huge international effort from all stakeholder groups to make result transparency a routine service to our patients and the public.

Spherical arrangements of small twinkle lights.

PW: When working with clients in MedTech and Pharma industries, Lionbridge regularly comes across clients who seek our advice on how to carry out readability testing in local language for plain language summaries. It is therefore my impression that there is a gap in regulatory guidance on suitable readability methodologies. Do you agree with this observation? It seems to me that EU should be frontrunners in creating effective readability solutions due to our many languages in the region. Why do you think regulators may have limited focus on readability testing despite the multilingual nature of the European Union?

IK: I agree but I don’t think that we will be able to solve this via EU guidance. The most suitable readability testing standard will have to be proposed, discussed, agreed upon and implemented as a result of collaboration between the sponsor and patient communities.

"It will require a huge international effort from all stakeholder groups to make result transparency a routine service to our patients and the public."

PW: Patients, trial participants and caregivers are increasingly seeking information on their own due to the general availability of health-related information and social platforms where information is freely shared. Do you think we will see more regulatory intervention on the use of social media platforms and how communication is shared by drug or device manufacturers on such platforms?

IK: Despite intensive discussions and a proposal from the Roadmap Initiative members, the final GLSP version does not give guidance on how to handle Lay Summary dissemination through social media platforms. Opinion building and decision making amongst regulators, ethics committees and sponsors have not yet come to a level that would allow giving general recommendations. Many aspects have to be taken into consideration. Covering this topic might be a subject for the next version of the GLSP recommendations.

PW: Health literacy is a challenge in the EU as well as in other regions. However, it is my impression that health literacy and plain language communication still have limited attention among industry players and regulators. Is this an accurate observation and why do you think this is the case?

IK: Improving health literacy is a tremendously long-term task because it requires raising the interest of the public in health issues. The coronavirus pandemic has shown us that a quantum leap in public interest is possible. A large portion of the public suddenly is interested in new vaccines and COVID-19 treatments, how they are developed and authorised, which trials have been performed and what their outcomes were. We have seen how critical it is to have experts who can explain research and results to the public to fulfill information needs. Lay Summaries, when prepared, translated and disseminated according to the agreed patient-centric GLSP standard, can become a very powerful tool to provide relevant information on all types of clinical research to an increasingly interested and knowledgeable audience.

An overview of relevant acronyms.
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Pia Windelov
Pia Windelov