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International Clinical Trials

The Clinical Development Plan – The Importance of Getting it Right

“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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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 past 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.

After receiving her PhD in developmental neurobiology, Julia Forjanic Klapproth started her career as a medical writer in the regulatory group at Hoechst Marion Roussel (later Sanofi) in 1997. Since then, she has been President of the European Medical Writers Association twice (2001-2002, 2007-2009). In 2002, Julia co-founded Trilogy Writing & Consulting, a company specialised in providing regulatory medical writing. In addition to managing the company as President/ Senior Partner, she writes a wide array of clinical documents including study protocols, study reports, and is specialised in the clinical parts of CTD submission dossiers.
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