Challenges in the design and analysis of clinical trials — ASN Events

Challenges in the design and analysis of clinical trials (#142)

Arul Earnest 1
  1. Monash University, Melbourne, VIC, Australia

The field of clinical trials has evolved rapidly in the past decade, specifically in the development of novel methods to design and analyse trials. This presentation will highlight a few specific examples across phase 1 to phase 3 trials. Phase 1 trials are usually designed to find the Maximum Tolerated Dose (MTD) with some target toxicity rate. Current methods to determine MTD have limitations. This talk will highlight the application of a new Bayesian optimal interval (BOIN) design that aims to overcome some of these challenges. Missing data is a perennial problem for researchers, both within observational studies and in RCTs. The amount of missing data as well as the nature of missingness can pose a challenge in the analysis of such data. The multiple imputation approach will be highlighted in this talk.

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