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A first step towards best practice recommendations for the design and statistical analyses of pragmatic clinical trials: A modified Delphi approach

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Pragmatic clinical trials (PCTs) are randomized trials implemented through routine clinical practice, where design parameters of traditional randomized controlled trials are modified to increase generalizability. However, this may introduce statistical… Click to show full abstract

Pragmatic clinical trials (PCTs) are randomized trials implemented through routine clinical practice, where design parameters of traditional randomized controlled trials are modified to increase generalizability. However, this may introduce statistical challenges. We aimed to identify these challenges and discuss possible solutions leading to best practice recommendations for the design and analysis of PCTs.

Keywords: practice; clinical trials; trials modified; best practice; pragmatic clinical; practice recommendations

Journal Title: British Journal of Clinical Pharmacology
Year Published: 2022

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