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Association Of Adaptive Early Phase Study Design And Late Phase Study Results In Oncology, Donna Elise Levy

Walden Dissertations and Doctoral Studies

This quantitative study assessed the association of the design methods used for early phase oncology studies (adaptive versus traditional) and the outcome of late stage clinical trials. Differences by cancer type and by drug classification were also assessed. The theoretical and conceptual frameworks used were the general systems theory and the design and evaluation of complex interventions, respectively. Units of analysis were individual oncology studies in the ClinicalTrials.gov database and Bayesian logistic modeling was applied on a random sample of 381 studies initiated after November 1999 to December 2016. When assessing study design and outcome, there were lower odds of …