In partnership with Trilogy Writing & Consulting
Regulatory
Lean medical writing: Story not storage
The most difficult task an author can face is clearly summarising a complex and data-filled clinical regulatory document and explaining the data. Barry Drees, co-founder and senior partner of Trilogy Writing & Consulting, discusses the recent concept of ‘lean medical writing’ (LMW), and how it is being implemented and used in the pharmaceutical industry.
linical regulatory documents tend to be long and complex, and filled with data. Nevertheless, these documents also need to succinctly summarise and explain huge amounts of data, and this is perhaps the most difficult task an author can face. In particular, the difference between simply presenting data (storage) versus using it to make a compelling argument (story), as is necessary for the regulatory authorities, 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 is the purpose of LMW and how is it implemented? Although it might appear that LMW involves using fewer words or less data, I would like to propose that rather than just ‘thin’ medical writing, lean involves more than this. In addition, the nature of regulatory documents dictates that they must provide
C Clinical Trials Insight /
www.worldpharmaceuticals.net
comprehensive information, while also being readable and summarising a huge amount of information. This leads to the paradox that documents should be complete while also being readable. The solution to this is LMW, which includes good use of document hierarchy and navigational tools.
User-friendly reading
A large component of this problem is that authors appear to concentrate on making sure every detail is included and often repeated, rather than providing it in a format that can be understood. The results are huge, obtuse and extremely difficult to read documents that are user-unfriendly. In contrast, the aim of lean medical writing is to produce documents that have all the necessary information, but in a form that is easy to access, read and understand. So, first, how can we resolve this paradox and give reviewers access to all of the data collected, while also presenting concise and informative summaries. The
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