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Current status of Bayesian clinical trials for oncology, 2020

Abstract:

Background: Bayesian methods had established a foothold in developing therapies in oncology trials. Methods: We identified clinical trials posted on the ClinicalTrials.gov database focused on Oncology trials with a Bayesian approach in their design. Differences in study characteristics such as design, study phase, randomization, masking, purpose of study, main outcomes, gender, age and funding involvement according to Bayesian approach were assessed using Chi-squared or Fisher's exact tests. Results: We identified 225 studies with Bayesian components in their design addressing oncological diseases. The most common designs were Bayesian Toxicity Monitoring (26.4%), Model-based designs (36%) Model-assisted designs (8%). Statistical methods such as Bayesian logistic regression model (59.4%), Bayesian piecewise exponential survival regression (10.9%) and the Continual reassessment method (9.4%) were the most used. Conclusions: Bayesian trials are more common in the early phases of drug development specifically in phase II trials (43.6%). Cancer institutes or Hospitals funded most of the studies retrieved. This type of design has increased over time and represent an innovative means of increasing trial efficiency.