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

Pharmaceutical Medicine https://doi.org/10.1007/s40290-020-00359-4 SHORT COMMUNICATION Plain Language Summaries of Clinical Trial Results: A Preliminary Study to Assess Availability of Easy‑to‑Understand Summaries and Approaches to Improving Public Engagement Michael Penlington1 · Harold Silverman2 · Ajithkumar Vasudevan3 · Priya Pavithran1 Accepted: 26 September 2020 © The Author(s) 2020 Abstract Background Easy-to-understand, stand-alone factual summaries of clinical trial results have the potential to improve public understanding of and engagement with pharmaceutical research. The European Clinical Trial Regulation (EU) No. 536/2014 is a major regulatory initiative that will result in a large number of such plain language summaries (PLSs) posted in the public domain. Today, however, little is known about the extent to which PLSs are written and are available to the general public. Objectives This preliminary study assessed (i) 20 top pharmaceutical companies’ positions on improving transparency and commitment to disclosing trial result summaries in an easy-to-understand format and (ii) the availability of such summaries in the public domain and the ease of locating them via general web searches. Methods The availability of PLSs in the public domain was estimated based on the number of EudraCT technical result summaries in four disease areas: chronic obstructive pulmonary disease, asthma, meningitis, and influenza. The likelihood of PLSs being easy to find through internet search engine queries by members of the public was assessed using Google. Results All 20 sponsors had committed to improve clinical trial transparency, 17 committed to sharing PLSs with trial participants, and 14 had at least one PLS available in the public domain. A total of 99 clinical studies in these four disease areas had technical summaries posted on EudraCT between 1 January 2017 and 30 June 2020. Of these 99, 14 studies had PLSs in the public domain. A total of 12 of 14 PLSs were directly captured by search engine. However, the sponsor trial identifier or EudraCT number had to be included in the search term to locate them. Generic search terms resulted in large volumes of non-relevant results. Conclusion Despite the progressive movement towards clinical trial transparency, easily accessible PLSs on clinical trials are currently scarce. The provision of a European mandate and framework for non-technical result summaries by Regulation (EU) 536/2014 will be a major step to bring about positive change. Plain Language Summary More patient and public involvement in healthcare research will help to speed the process of making new medicines. This is known by both the regulators and the healthcare industry. The healthcare industry wants to make more information on human research studies available to patients and the public. One way to help achieve this is to write simple summaries of clinical study results. Here, we use the term plain language summary (PLS) to describe them. The PLS allows people to understand human research studies more clearly. A new law will soon make it necessary to write a PLS for every clinical study done in Europe. But, today, is the PLS being used to inform the public about clinical research studies? And what is Digital Features To view digital features for this article go to https://doi.org/10.6084/m9.figshare.12997565. * Michael Penlington 1 GSK, Wavre, Belgium 2 GSK, Rockville, MD, USA 3 GSK, Bengaluru, India Vol.:(0123456789) M. Penlington et al. its potential? We found only a few researchers have already begun to write PLSs. PLSs on most studies are not available to the public. Even those PLSs on public websites are very hard to find through a Google search. To better understand the potential of PLSs we are doing more research. This research will look at what the public wants to know about these studies and how they will retrieve this information. Key Points The top 20 pharmaceutical companies have public positions committing to clinical trial transparency; 17 of them committed to sharing simple patient-focused summaries with trial participants, 9 indicated they would share such summaries with the public, and 14 of them had posted at least one of these in the public domain. Relatively few completed studies (14/99) with technical summaries posted in EudraCT in four major disease areas had publicly available patient-focused summaries. The few plain language summaries in the public domain are not easily detected by internet search engine, thereby limiting their utility as a vehicle to improve public health literacy on clinical trials. 1 Digital Features To view digital features for this article go to https://doi. org/10.6084/m9.figshare.12997565. 2 Introduction 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. Clearly, the industry still has some way to go before relevant information on every clinical trial becomes ubiquitously available to all. Reviews of posting requirements for technical research summaries on EudraCT and clinicaltrials.gov have revealed gaps in compliance [3–5]. Nonetheless, the clinical trial transparency movement has progressively evolved [6]. Initiatives promoting trial transparency have been announced by the FDA (the FDA Amendments Act of 2007), the European Medicines Agency (Directive [EU] 2001/20/EC), and journal editors [7]. Posting requirements from national authorities have increased, with some now requiring disclosure of the full protocols and clinical study reports [8, 9]. Initiatives on disclosure of technical clinical trial material have undoubtedly increased the availability of information to those working in clinical research. However, the information they present is typically complex and not easily understood by people who do not have a scientific or medical background [10]. In addition, these postings may not be easy to find without prior knowledge of the existence of specialized hosting portals. The utility of these technical documents for patients and the general public may therefore be limited. Consequently, there has been a push to establish policies and practices to facilitate patient and public involvement and participation in clinical research. In the European Union, Clinical Trial Regulation (Regulation [EU] No 536/2014) is a major step towards improving the transparency of clinical research, thereby potentially increasing engagement with patients and the public [11]. This regulation creates the Clinical Trials Information System (CTIS) for studies conducted within The Europea (...truncated)