Journal of Biometrics & Biostatistics

Roberto Gomeni

Publications

• Research Article
  Adaptive Randomization Study Design in Clinical Trials for Psychiatric Disorders
  Author(s): Roberto Gomeni and Navin GoyalRoberto Gomeni and Navin Goyal
  
  Abstract Background: Uncontrolled placebo response has been one of the major culprits in the failure of randomized clinical trials for depression. A major drawback associated with the presence of high placebo response is the increased noiseto- signal ratio that in a majority of cases prevents the detection of treatment effect. The aim of this work was to propose an adaptive randomization study design based on band-pass filtering and evaluate this approach when compared to the traditional study designs. Results: Clinical trial simulations demonstrated that an adaptive randomization approach always outperformed the conventional study designs in improving the signal-to-noise ratio. The improvement directly correlated with the level of placebo response and the variability in response across centers. The proposed strategy does not warrant a.. Read More»
  DOI: 10.4172/2155-6180.1000187

  Abstract PDF