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Medical and scientific writing: Time to go lean and mean.

The Lean Six Sigma methodology for process improvements and driving efficiency is old, but lean writing was adopted late by the pharmaceutical world in terms of size of the documents. The documents were lean earlier, and then became voluminous, and now we are about to complete a full circle in this regard, i.e., coming back to the lean documents again using e-formats and hyperlinking. Furthermore, writing has become more and more precise over time. The need for this lean and mean medical and scientific writing arose from voluminous research globally, both industry and academia which are abuzz with skyrocketing regulatory and scientific submission volumes. The quantum of literature is so much that reviewers or information seekers firmly believe that going through even selected and relevant literature has become highly challenging. Considering this, there has been much insistence on downsizing the medical writing documents, which could be tempting enough to be leveraged for scientific publications as well. Here, we present the need for lean and mean medical writing, discuss this concept in relation to the pharmaceutical industry, and how to apply this to key documents. Furthermore, presented is the proposed algorithm for lean and mean clinical study reports and manuscripts. These thoughts are aligned to the recently established concept of data transparency, and can be easily achieved by web links between the protocols and clinical trial results disclosed publicly, and the corresponding manuscripts.

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