The pressure of public scrutiny – Kinapse on whether the EMA’s demands for Plain Language Summaries for clinical studies, that are understandable by anyone, tip sponsors over the edge?

From 2019, to comply with requirements for greater transparency around clinical research, encapsulated in the EU Clinical Trials Regulation 536/2014 (Article 37), life sciences firms will have to prepare plain language summaries (PLSs) of their clinical studies that can be understood by lay readers as well as clinical experts. For trial sponsors, this is a significant undertaking.

Challenges and concerns include:

•          Clinical teams and medical writing specialists struggling to understand what to include/leave out and how to pitch the summaries so that patients’ families and other people with no prior clinical knowledge/understanding of technical terms can appreciate the findings
•          Competing priorities of clinical and compliance teams – eg:

o   Real fear of litigation if over-simplified or potentially misleading summaries lead to people taking drugs inappropriately and suffering adverse reactions

o   Achieving a balance of including enough information (so not to overwhelm the reader) without ending up with a PLS that gives the wrong impression of a clinical study and its outcomes)

o   Worries about conclusions being taken out of context – ie if the wider trial context and findings are not adequately explained

o   Worries about being accused of ‘cherry-picking’ which findings and safety data to include if it can’t all go in the summary

•          Relative roles and responsibility

o   The EMA is not planning to review each PLS submission, so it will fall to sponsors/responsible persons to get this right

•          The need for a whole new set-up to support the PLS requirement – from training to standard operating procedures (SOPs) and document templates
•          The EMA’s expectation that patient advocacy groups will be involved in reviewing summaries to ensure they can be easily understood and are meaningful and of value to the target reader
•          The reliability of translations – with over 20 EU member states requiring summaries in their own local language, robust processes must be put in place to ensure that nothing important is lost or distorted in translation
•          How summaries will be managed and distributed to target audiences retrospectively – ie. for historical trial studies
•          Managing timelines: there are no planned fines for non-compliance with PLSs, but EMA is likely to require these additional documents from next year and there is a LOT of preparation involved to get this right – including process testing/document reviewing.: