For more than two decades, transparency has been an aspirational goal of the European Medicines Agency (EMA). The EU-regulation (536/2014) that has been effective since 2015, took transparency one step further. It mandates that all sponsors of clinical studies need to make the study results available, not only as a scientific summary but also as a summary “that is understandable for laypersons”. The plan is that the clinical study report, the scientific summary and the layperson summary are posted on the same location on the EU-portal. Thus, for the very first time, everybody will have access to the results of any clinical study in Europe. The web infrastructure, i.e., the EU-portal, is currently being developed and is likely to “go live” in autumn 2018.
Patient organizations and the pharmaceutical industry have warmly welcomed this development as it will enable patients to make more informed choices.
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Unfortunately, the guidance in the EU regulation on the content of lay summaries is scant. All the requirements are summarized in a 10 item bulleted list (Box 1). While some of these demands seem straightforward (name and contact details of the sponsor), other must-haves are either unclear or difficult to fulfil (inclusion and exclusion criteria, overall results, adverse reactions).
What’s more, the European Commission must have felt that guidance beyond the regulation was needed and, as a result, asked the Health Research Association (HRA) in the UK to draft an interpretation guide. The HRA draft of lay summary recommendations was reviewed by the European Commission and subsequently a “Consultation Document–Summary of Clinical Trial Results for Laypersons” was published in May 2016. The consultation period ended on 31 August 2016. Currently, the many comments are being evaluated and a final guidance document is expected “between the end of 2016 and mid-2017“.
The “Consultation Document” was a big step forward in clarifying what should go into a lay summary. It covers most aspects of the design, writing, and distribution of lay summaries. The topics include:general principles, health literacy, readability and use of plain language, numeracy, visuals, language, and communication of return of results to participants. In addition to the main text, two annexes are included. One annex is a kind of template for a lay summary and the other gives guidance on neutral language.
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The Consultation Document clarifies that the intended audience of lay summaries is the general public. Lay summaries should be understandable for people with low literacy skills, i.e. for people at or below the level of high school completion.
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By GlobalDataThe Consultation Document recommends that lay summaries should be written in such a way “that no prior knowledge of the trial” is needed to understand them. Importantly lay summaries should be short and succinct. At the same time, they should also include details on the purpose of the trial, why the study was carried out, why the comparator was chosen, and any critical changes made during the study. Furthermore, details should be provided on the primary endpoint, patient relevant secondary endpoints, key patient reported outcome measures (PROMS), or other quality of life indicators of interest to patients. Additionally, the safety data should be presented in detail. The Consultation Document requires, “The side effects should be laid out as they would be in a regular Patient Information Leaflet. The most serious adverse reactions need to be listed first, followed by all other side effects listed by frequency (starting with the most frequent) and not repeating the most serious side effects listed above. Frequencies should be given in numerical terms as well as percentages (X out of X patients [Xpercent]) following the principles of numeracy. […] The number of serious adverse reactions and deaths should be clearly stated together with any adverse events which have led to the early closure of the trial or the withdrawal of patients.”
There is no question that all of this information might be useful for the general public. However, one can’t help realizing that the entirety of the requirements in the Consultation Document constitutes a program for failure. How should all this information be comprised in a “short” document with “adequate white space”? And brevity is no small thing when it comes to the general public. For readers with low reading skills, reading is exhausting and therefore they are unlikely to even attempt a document that spans several pages. For health information it is established that the longer the document, the smaller and the better educated the group of people who will read it in full.
A similar issue arises with the recommendation to apply the “principles of numeracy”. The OECD defines numeracy as “the ability to access, use, interpret, and communicate mathematical information and ideas, to engage in and manage mathematical demands of a range of situations in adult life” (OECD 2012). Thus lay summaries should be written for people who find it difficult to deal with information expressed in numbers. However, the first principle of numeracy is to avoid numbers where possible. But how can this be achieved in a lay summary that needs to be factual in the description of a long list of endpoints, and that should providea large amount of numerical information on side effects?
In its present form, the Consultation Document amounts to a wish list that numerates many items that need to be covered in a lay summary. By invoking this long list of requirements, the initial purpose is endangered: providing help for the writing of lay summaries. A closer look at the various requirements shows that many objectives are in competition with one another (Table 1).
One would have hoped that the lay summary guidance document would not only list the requirements, but that it would also provide advice on how to prioritize the information. If sponsors aim for short lay summaries, they make them accessible for the intended audience. However, then not all information can be included. Conversely, if all information needs to be included, the resulting lay summaries will fail their intended purpose, i.e. they will be much less accessible for readers with low literacy skills. There is simply no having the cake and eating it!
As the final guidance document is currently being developed, one might hope that it will offer approaches on how to achieve the many competing objectives put forward in the draft Consultation Document.
Box 1:
*The views expressed in this article are solely those of the author's and do not represent Boehringer Ingelheim Pharma. Unlimited copyright is with the author
References
Rampey, B.D., Finnegan, R., Goodman, M., Mohadjer, L., Krenzke, T., Hogan, J., and Provasnik, S. (2016). Skills of U.S. Unemployed, Young, and Older Adults in Sharper Focus: Results From the Program for the International Assessment of Adult Competencies (PIAAC) 2012/2014: First Look (NCES 2016-039). U.S. Department of Education. Washington, DC: National Center for Education Statistics. Retrieved 29 Nov 2016 from http://nces.ed.gov/pubsearch.[Contains interesting data on literacy and numeracy skills for many countries in Europe and Asia].
EC Consultation Document: Summary of Clinical Trial Results for Laypersons, Recommendations of the expert group on clinical trials for the implementation of Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use. [This is the version that was made available for public consultation] https://ec.europa.eu/health/files/clinicaltrials/2016_06_pc_guidelines/gl_3_consult.pdf
REGULATION (EU) No 536/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. http://ec.europa.eu/health/files/eudralex/vol-1/reg_2014_536/reg_2014_536_en.pdf
Brauburger K, Sroka-Saidi K, Schindler TM: New European Clinical Trial Regulation:The Requirement for Lay Summaries and Its Impacton Medical Communicators. AMWA Journal, V30 N2, 2015, 60 -63.
[This paper summarizes the many issues with the 10-item bulleted list in the EU-regulation.]Contact: thomas.schindler@boehringer-ingelheim.com
