Last Updated: February 1, 2019 11:11AM
Takeaways from the 3rd Annual Lay Summaries Summit, 24-25 September, Philadelphia
The 3rd Annual Lay Summaries Summit was held in Philadelphia in September, and Lionbridge was the only Language Service Provider to attend. This surprised us, as lay language summaries of research results are as much a linguistic exercise as a scientific one. At Lionbridge, it’s part of our collective DNA to stay abreast of the driving forces in the industry, so we can best serve as a compliance partner for our pharma clients.
How can you engineer for change within your organization? Here are some of our key takeaways from the Summit that may help.
The lay of the land
What are lay language summaries, and why are they relevant to pharma companies?
As succinct recaps of a clinical study’s main results, lay language summaries convey what happened and why in simple terms that an average person of average literacy can understand. Pharma companies should take special note of lay language summaries’ importance; under the new EU Clinical Trial Regulation (EU No. 536/2014), lay summaries will soon (read: most likely by 2020) become a legally enforced regulatory requirement for trial sponsors conducting interventional trials in the EU.
More than any other industry, the pharma sector is subject to public scrutiny surrounding ethical behavior, scientific credibility, and compliance. Given this shadowy backdrop, adequately sharing clinical results with the public is no trivial task for a trial sponsor. Nonetheless, the public expects—and needs—transparency on clinical research results, and trial participants appreciate summaries in plain language at the trial’s conclusion. Unsurprisingly, a 2017 global survey conducted by CISCRP on public and patient perceptions of clinical research indicated that more than 91% of the public would value a summary of clinical trial results, yet only 51% of those who participated in a clinical trial in the past actually received a trial summary or results update. We know this gap needs to close: sponsors need to return meaningful clinical results to trial volunteers and public audiences.
Discussions at the Summit pointed to the need for:
1. Forthright transparency: Although Summit attendees expressed concern regarding the best way to ‘do the right thing’, they universally committed to bring increased transparency and disclosure on clinical research results to trial volunteers and the global population-at-large. Returning clinical results to clinical trial participants is not a novel concept; indeed, this form of follow-up can boost interest in clinical trials, build trust in the research community, and facilitate patient retention during clinical trial execution.
2. Utmost integrity: Transforming scientific results into appropriate lay language communication without sacrificing or unintentionally skewing results is difficult. As a trial sponsor, you cannot afford to lose scientific validity or be accused of skewing results or “cherry-picking” outcomes in the process. Communicating clear results in easily digestible language requires staffing, training, and funding. In addition, it may be hard to achieve commitment from investigators to distribute summaries at the end of the trial. It’s thus imperative to form a plan that encourages summary distribution.
3. Responsible data disclosure: Summit participants working in clinical research discussed the sensitivity surrounding the disclosure of trial results before a drug is authorized, and how results in a pivotal phase III trial may impact external stakeholders including investors, prescribing physicians, payers and patients. Sharing—responsibly—is paramount.
Key takeaways from a language perspective
1. Translation of lay summaries into local language is a critical step in effective communication of clinical trial results. High-quality translations are necessary, and all local language versions should align with the master summary while incorporating unique principles of cultural literacy. Returning results is about more than transparency and information-sharing: it’s about communication. Some trial sponsors may choose to centralize translations through a single language service provider to retain control of the translation process and avoid multiple versions or inconsistencies across local language summaries.
2. Lay communication is a learning process, and sharing best practices is beneficial.Pilot studies presented at the Summit evidenced the existence of a learning curve toward effective communication of research results in plain language and indicated that experience-sharing makes a lot of sense. The benefits of incorporating a language service provider to the annual lay summit to collectively discuss linguistic challenges and determine how to optimize translations are obvious.
3. Guidance is available, but there is a missing piece. Annex V in the EU Clinical Trial Regulation provides a list of 10 items that must be included in the summary of the result for laypersons. MRCT (the Multi-Regional Clinical Trials Center and Brigham Women’s Hospital and Harvard) and an EU expert group (coordinated by the European Commission) have published guidelines on how to develop lay summaries in a non-scientific, non-promotional, and non-biased manner. The guidelines are helpful and build on principles of health literacy, numeracy, and a patient-centric approach to communication. These resources, though, do not include detailed guidance on translating the summary into culturally-appropriate terminology. This is one area where a language service provider can help.
Making simple sense of science
Authoring lay summaries of scientific content requires language skills as well as experience with clinical trials and medical terminology. Scientific and plain language results are two very different types of communication, and there is no linguistic correlation between the semantics or the syntactics of a scientific and a plain language text.
Whereas scientific writing primarily focuses on presenting objective content to peers in a scientific community, patient-centric communication attempts to help a heterogeneous lay audience gain understanding in a language and style that presumes no medical knowledge or academic jargon. The exercise therefore requires a combined skill set of scientific and linguistic capabilities.
At Lionbridge, we offer this full skill set. We are ready to help trial sponsors author and translate plain language summaries of clinical trial results that comply with the new EU Regulation and best practices of MRCT and the EU expert group.
Our life sciences translation team is proud to support our clients as they successfully address new compliance requirements that will shape how the pharmaceutical world communicates. Please reach out to us to learn more.