Lay Summaries of Clinical Study Results: An Overview

Abstract

The European Union Clinical Trials Regulation (EU CTR) 536/2014 includes a requirement for the submission of lay summaries. Study participants, advocacy groups, and, to a lesser extent, the general public have called for greater transparency in their quest for information on clinical studies. As a complement to other forms of clinical study disclosure such as registry postings and scientific publications, lay summaries may aid in the transparency of a sponsor's clinical study results, thereby promoting trust, partnership, and patient engagement throughout the clinical study process. The data transparency field is changing rapidly; therefore, data owners should strive to stay abreast of the changes and deliver meaningful tools to their study participants and the public. Points to consider when developing lay summaries of clinical study results include regulatory drivers, the target audience, communication of complex data in a lay manner, and efficient processes for the development of lay summaries within one's company. Plain Language SummaryThere is a rule in Europe that clinical studies (experiments in humans) must have a summary written in plain language. Summaries written in plain language help people who are not scientists or doctors understand complex medical information. People who participate in clinical studies, and others, may want to know information about clinical study results. Lay summaries are a way to share clinical study results, but they do not replace other ways that information is shared. Lay summary writers must think about how they can help readers understand the information. It is hard to describe the results of clinical studies in a way that everyone can understand. This article gives some ideas to think about when writing lay summaries. * Amber Barnes amber.barnes@ucb.com 1 UCB Bioscience, RTP, 8010 Arco Corporate Drive, Raleigh, NC 27617, USA Key PointsLay summaries of clinical study results are a complement to other forms of clinical study disclosure that aid in the understanding of complex clinical study results.The initial requirement for lay summaries began as a result of the EU Clinical Trial Regulation; however, evolving regulations and policies around the globe are shaping the future of clinical study disclosure.Ensuring patient value should be of paramount importance when developing lay summaries.

Open to the public: paywalls and the public rationale for open access medical research publishing

“…Lay summaries accompanying publications may help to make open access research more navigable by members of the general public [52]. Recognizing the importance of lay summaries for public transparency and communication of clinical trial results, the European Medicines Agency has made the provision of lay summaries a requirement through the European Union Clinical Trials Regulation (EU CTR) 536/2014 [53]. This regulation will require a lay summary for all registered European Union clinical trials.…”

Straight From the Scientist’s Mouth—Plain Language Summaries Promote Laypeople’s Comprehension and Knowledge Acquisition When Reading About Individual Research Findings in Psychology

“…On a more finegrained level, one may, however, question if high trust in science is desirable in all circumstances-especially if there is uncertainty with regard to the robustness of scientific findings in a certain discipline. Since plain language summaries are a way of achieving higher transparency of the research process (Barnes & Patrick, 2019;Kuehne & Olden, 2015), we argue that they may provide a way to earn trust for those studies that actually deserve it. A recent study corroborates this argument (Carvalho et al, 2019): scientific articles that provided plain language summaries had a higher methodological quality compared to articles that did not.…”

Plain Language Summaries of Clinical Trial Results: A Preliminary Study to Assess Availability of Easy-to-Understand Summaries and Approaches to Improving Public Engagement

“…Understandable, easy-to-read summaries of clinical research have been recognized as providing greater transparency to those interested in learning about clinical trial results [ 2 ]. As such, the PLS may become an important component in the movement to increase public awareness and subsequently stimulate engagement in clinical research.…”

“…Patients, advocacy groups, and the general public are demanding greater transparency of information on clinical studies [ 1 , 2 ]. Sharing objective, easily accessible, unbiased research information in a timely manner complements other initiatives to build trust, partnership, and engagement throughout the clinical study process [ 2 ]. Ultimately, improvement in public health literacy and trust between the pharmaceutical industry and the public will help develop new medicines [ 1 ] and vaccines.…”

“…Preliminary evidence from our own unpublished data (in preparation) on vaccines and the accounts of others [ 15 ] suggest that clinical research is seen as important for the development of new medicines and vaccines. Despite growing public interest in clinical research and the pending European clinical trial regulation, little is known about the availability and accessibility of such documents in the public domain [ 2 ].…”