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Innovative Clinical Trial Designs — Welcomed By Regulators But What About The Payers?

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There is a well-recognized long-standing decline in R&D productivity in the pharmaceutical industry which has driven exploration of new approaches to the clinical development of pharmaceuticals (Scannell, 2012). These include innovative randomized controlled trial designs, such as adaptive, umbrella, basket, and pragmatic studies.

There will be pragmatic attitudes amongst payers regarding the use of innovative clinical trial designs however there will also be skepticism; for many HTA bodies this is new and uncertain territory.