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Driving Industry Impetus

ICT: What have the current expedited vaccine trends meant for patient data in Phase IV studies?

Tom Nichols: This could be a pivotal period for the increased use of postauthorisation safety studies (PASS). However, I think this is more from a perception point of view. Ultimately, if the first generation of COVID-19 vaccines are found to prove their positive benefit-risk balance, then an early approval plus proactive pharmacovigilance (PV) will be seen as a model to follow. Identifying risks is great for wider perception, as long as they are rare.

However, if major problems with the vaccines are found, this will lead to more caution when approving drugs early, with additional studies requested.

Neither would necessarily be the right decision to take, but understandable based on the current focus on optics.

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About the Author

Tom Nichols started his industry career in medical information, but soon realised that his passion was for PV. He has worked across the full PV spectrum from early phase clinical trials through to generics. Following a period heading up the PV function at a leading CRO, he decided his own consultancy and PV service provider, Drive Phase PV. He is an Honorary Fellow of the Pharmaceutical Information and Pharmacovigilance Association (PIPA), and has served on the committee for several years. In 2020, he stepped into the position of PIPA President.
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