The final countdown: Lay Summaries are about to be mandatory

Are your teams well-prepared to produce fit for purpose Clinical Study Report Lay Summaries?

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Why attend?

Now that the European Commission has confirmed that the portal for upload of Clinical Trial Lay Summaries will open on 31 January 2022, the requirement for Lay Summary production is about to become mandatory. This is a unique chance for pharmaceutical companies to engage with the general public, but only if executed properly.

Over the last few years, we have seen both great and not-so-great examples of Lay Summaries as many companies have been preparing these on a voluntary basis. The take-home message is that this task is not as easy as everyone thinks, and well-thought-out templates and processes must be put in place if we want to make sure that Lay Summaries facilitate rather than hinder communication with the lay audience. This webinar will serve as a sanity check and will help you understand if your company’s Lay Summaries are really fit for purpose.

Lay Summaries have been causing concern and confusion in the industry since their first mention in 2014 as most regulatory documents tend to be written for a scientific audience. In contrast, the Lay Summary must explain the trial and its results in a way that is non-promotional, non-biased, comprehensive, and understandable to patients and members of the general public without scientific training. ​

​Although the pharmaceutical industry has some experience in writing for the public because of the preparation of Package Inserts and Patient Information, the Lay Summary presents some unique challenges in that it requires not just jargon-free language, but also presentation of data appropriate for the public. Explaining trial results can be very difficult considering that health numeracy levels in the general population are low. Technical terms such as numbers needed to treat, data tables and graphs that are commonly used in clinical research may not be so easy to understand for the public. There is also the issue of interpretation of the clinical relevance of primary, secondary, and exploratory analyses. This can be a challenge even for a scientifically literate audience. ​

In this webinar, Lisa Chamberlain James and Barry Drees, Senior Partners at Trilogy Writing & Consulting, will outline the main requirements of the regulations, explain the main challenges faced when writing a Lay Summary and show how to overcome these based on their experience. If you want to make sure that your company is well equipped to produce fit for purpose Lay Summaries and can effectively utilize the unique opportunity to engage with the general public, join Lisa and Barry for this discussion!​

Key Learning Objectives

  • Understand the main challenges of writing for the general public.
  • Understand the principal requirements of the Clinical Trials Regulation with respect to Lay Summaries.
  • Discussion of how to write for the general public.
  • Discussion of challenges related to Lay Summaries in particular and how to overcome them.

Speakers

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Lisa Chamberlain James
Senior Partner

Lisa Chamberlain James is a Senior Partner of Trilogy Writing & Consulting and has a special interest in drug safety and patient information. She has experience of both communications and regulatory medical writing and runs and assesses workshops for EMWA. She is a member of EMWA’s Educational Committee, Chair of the Communicating with Patients Special Interest Group, PV Special Interest Group, Med Comms Special Interest Group, a Fellow of the Royal Society of Medicine, and editor of the Medical Communications and Writing for Patients section of the journal Medical Writing.

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Barry Drees
Senior Partner

Barry Drees received his Ph.D. in molecular genetics at the University of California at San Francisco in the 1986. Following his postdoctoral work as a fellow of the National Institute of Health, he worked as a medical writer in the pharmaceutical industry at Hoechst/Aventis for 12 years, setting up a Phase I writing group and leading several regulatory submission teams. Barry is a frequent speaker on medical writing, statistics, and other scientific communication topics for Management Forum, DIA, and EMWA as well as various pharmaceutical associations. He is the former Editor-in-chief of The Write Stuff, the Journal of EMWA, and was the President of EMWA 1996-1997. He is currently a Co-founder and Senior Partner of Trilogy Writing & Consulting, continuing to personally lead submission teams as well as providing training for the industry around the world.

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