RCT Simulations for Enhanced Tuberculosis Clinical Trial Design

EasyChair Preprint no. 11981

Abstract

Clinical trials, pivotal for evaluating medical interventions, are undergoing a shift with Clinical Trial Simulation (CTS). CTS optimizes trial design, providing a cost-effective, evidence-based approach to drug development and intervention testing. The primary objective of this study is to use the power of simulations to evaluate the effectiveness of behavioral interventions, specifically addressing alcohol, depression, and tobacco as risk factors, in enhancing tuberculosis treatment outcomes. Implementing a robust power analysis framework and introducing the concept of “resimulations”, our study enhances statistical rigor and reliability across various intervention scenarios. This offers a versatile approach applicable to diverse research areas, providing a comprehensive framework to design and simulate Randomized Controlled Trials (RCTs), enabling reliable robust clinical studies.

Keyphrases: Biostatistics, clinical trial design, Comorbidity, Intervention Testing, randomized controlled trials, Sample Size Optimization, simulations, Statistical Power Analysis, Tuberculosis

@Booklet{EasyChair:11981,
  author = {Aditya Mavle and Aarushi Wagh and Atharva Nagmoti and Nikhil Gupte},
  title = {RCT Simulations for Enhanced Tuberculosis  Clinical Trial Design},
  howpublished = {EasyChair Preprint no. 11981},

  year = {EasyChair, 2024}}