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

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 summaries: A systematic review of theory, guidelines and empirical research

“…We identified 15 empirical articles on PLSs that evaluated one type of PLSs, for example by investigating how readers reacted to a certain PLS, or how easy they can be found. Researchers evaluated Cochrane PLS that address common health issues [ 11 , 57 ], summaries of studies from the Newcastle Cognitive Function after Stroke cohort [ 45 ], consumer summaries of Cochrane Musculoskeletal Reviews [ 23 ], lay summaries on how package sizes affect the consumption of food, alcohol and tobacco [ 28 ], lay summaries on open access journal articles [ 3 ], lay summaries of pragmatic pediatric clinical trials [ 19 ], lay summaries on HDBuzz, a knowledge translation website with a focus on research on Huntington’s disease [ 52 ], PLSs of clinical trials in general [ 21 , 93 , 94 ], PLSs of clinical trials in Japan [ 95 ] and PLSs posted as ‘eLife digests’ [ 8 , 66 ]. There was also one study that investigated how the commitment of volunteer PLS authors can be raised [ 96 ] and one study that developed and tested a PLS template in detail [ 78 ].…”