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International Clinical Trials

Won’t Someone Think of the Children


Please forgive me for breaking the ‘fourth wall’ in this initial paragraph, but it is important to understand the philosophy behind the content. In the very early noughties, I was advised by a highly respected paediatric clinical research specialist that ‘children are not little adults’. That absolute truism, whilst blindingly obvious, is repeatedly ignored by many of our compatriots in the world of clinical development. Over the last 20 years I have seen clinical protocols across most therapeutic areas, developed by organisations from the largest pharmaceutical companies to the smallest ‘virtual’ companies, that spectacularly ignore it. Even today, protocols cross desks that take no account of this most vulnerable of patient groups, their guardians, or their care givers. While we are seeing a reduction in the superfluous tests, samples taken, and investigations for academic interest with no potential clinical benefit to the child, there remains an intrinsic lack of thought in many protocols to the emotional impact clinical studies have on the ‘subjects’.

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Douglas Cookson is a 34-year veteran of the healthcare industry, having spent almost half his career in Large Pharma, biotech, and surgical/medical devices, and the rest specialising in clinical development. He has worked in the largest, as well as some of the best, niche CROs, CDMOs, and CTSOs providing unique insights into the development of new treatments. He is the Vice-President of Commercial Development at MRN (Market Leading DCT provider) and a member of the DTRA Leadership Council.

 
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