Abstract
Clinical trial design is an important part of robust evidence generation for pharmaceutical manufacturers submitting a health technology assessment (HTA). Factors such as randomisation, blinding, and comparator selection are typically considered fundamental, yet clinical trial site locations are not known to drive HTA decision making, despite being discussed anecdotally. The UK is widely considered a hub of clinical research, with UK-based clinical trial sites allowing early patient access to medical innovation. Considering the regulatory uncertainties arising from BREXIT on the operation of UK trial sites, and because the National Institute for Health and Care Excellence (NICE) does not explicitly call for mandatory UK-based research, this study was conducted to investigate the benefit of UK-based trial sites in securing a positive NICE HTA decision.
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