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“By failing to prepare, you are preparing to fail.” – Benjamin Franklin
“Every battle is won or lost before it is ever fought.” – Sun Tzu, The Art of War, 5th century BCE
The wisdom of the ages, for thousands of years, has been that good planning is essential for the success of any project, and generally, the more complex the project, the more important the planning is for it. Many historical disasters can rightly be attributed to poor or non-existent planning.
Given the extreme complexity and difficulty of developing new pharmaceutical products, one would think that the planning for such an endeavour would be taken very seriously. Yet, somewhat surprisingly, it frequently is not. As medical writers specialising in regulatory submission dossiers, we have seen many clinical development programmes that are nearing their end and heading towards submission to authorities for marketing application, and, yet, seem to be lacking any real master plan. It is astonishing how little cohesive thought has sometimes been put into the series of studies performed, such that, at the time of submission, some key questions remain unanswered. As a result, writing the submission dossier is a bit like trying to weave together a piece of swiss cheese – we need to dance around the holes in the storyline, while still trying to defend and support the planned label claims.
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