IN PARTNERSHIP
document almost impossible to achieve for all but the most simple of studies. This is a great shame (and cause of much frustration) because arguably a plain-language Protocol Synopsis is most needed for more complex studies. Some companies are ignoring the
recommendation. Some are exploring the use of a glossary to allow them to circumvent the two-page limit by adding explanations of terms and abbreviations to a separate document. Unfortunately, this not only risks uncoupling the glossary from the main text, but also requires the reader to do quite a lot of memory work and cross-referencing, just to be able to understand the document – surely the opposite of what any plain-language document, but especially the Protocol Synopsis, is trying to achieve. However, the authority must be applauded
for recommending a version of the Protocol Synopsis in lay language. The concept is sound why a study was done for the general public is needed and necessary. Additionally, the Protocol Synopsis could and should form a great basis for the Lay Summary of Clinical Trial Results document, and the plain language used in the Informed Consent Form could be brought to both documents, minimising effort and simplifying the messaging for the general public. A suggested page limit is a very sensible strategy to avoid long, convoluted, unclear documents (whether in plain language or not!), but I fear that having a strict limit disincentivises companies to even try to produce these documents in plain language – the task in many cases is just too daunting, if not unachievable. My hope is that the authority allows some
flexibility on this page limit. Surely it would be better to have a three-page Protocol Synopsis that is clear and understandable, than a two-page document that the public cannot understand?
References 1.
https://eur-lex.europa.eu/legal-content/EN/ TXT/?uri=celex%3A32014R0536. Accessed 12/10/2022.
2. dir_2001_20_en_0.pdf. Accessed 12/10/2022.
3.
https://health.ec.europa.eu/latest-updates/update-eudralex- volume-10-clinical-trials-guidelines-questions-and-answers- document-regulation-eu-2022-09-26_en. Accessed 12/10/2022.
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