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Lean Medical Writing: Story Not Storage



Clinical regulatory documents tend to be long, complex, and filled with data. However, as a regulatory reviewer famously said about clinical documentation: “I usually do not see good documents. What we seem to get are pages and pages that are not directly related to the question. It is hard to find the time to go through all of that stuff.” Nevertheless, these documents also need to clearly and succinctly summarise and explain huge amounts of data, and this is perhaps the most difficult task that an author can face. In particular, the difference between simply presenting data (storage) vs using them to make a compelling argument (story) is necessary for the regulatory authorities, however, is often not understood or practiced. This is a general problem in clinical writing where an encyclopaedic style seems to be the standard.

Against this long tradition is the fairly recent concept of ‘lean medical writing’ (LMW), which is becoming increasingly widespread throughout the pharmaceutical industry. What exactly is the purpose of LMW and how is it implemented and used? Although it might appear from the name that LMW involves just using fewer words or less data, I would like to propose that rather than just ‘thin’ medical writing (fewer words and less data), lean involves much more than this. The nature of regulatory documents dictates that they must provide comprehensive information, while also being readable and summarising a huge amount of information. This leads to the paradox that such documents should be complete while at the same time also being readable. The solution to this is LMW, which includes good use of document hierarchy and navigational tools.

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About the Author

Barry Drees received his PhD in Molecular Genetics at the University of California, US. Following his postdoctoral work as a fellow of the National Institute of Health, he worked as a Medical Writer at Hoechst/Aventis for 12 years. Barry is a frequent speaker on medical writing, statistics, and other scientific communication topics for a number of associations and companies in the pharma industry. He is a former President of the European Medical Writers Association (EMWA) and is a former Editor-in-Chief of the EMWA journal. He is currently a Co-Founder and Senior Partner of Trilogy Writing & Consulting, continuing to personally lead submission teams and provide training for the industry around the world.
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