Selected article for: "clinical trial and final approval"
Author: Qingyang Xu; Shomesh Chaudhuri; Danying Xiao; Andrew W Lo
Title: Bayesian Adaptive Clinical Trials for Anti-Infective Therapeutics during Epidemic Outbreaks
  • Document date: 2020_4_14
    • ID: 20hk99h4_2
    Snippet: In recent years, Bayesian adaptive RCT protocols have been increasingly used to expedite the clinical trial process of potentially transformative therapies for diseases with high mortality rates (Berry, 2015) . Currently, these protocols have mainly been applied within the oncology domain, such as I-SPY for breast cancer (Barker et al., 2009 ) and GBM AGILE for glioblastoma (Alexander et al. 2018) . These studies use Bayesian inference algorithms.....
    Document: In recent years, Bayesian adaptive RCT protocols have been increasingly used to expedite the clinical trial process of potentially transformative therapies for diseases with high mortality rates (Berry, 2015) . Currently, these protocols have mainly been applied within the oncology domain, such as I-SPY for breast cancer (Barker et al., 2009 ) and GBM AGILE for glioblastoma (Alexander et al. 2018) . These studies use Bayesian inference algorithms to greatly reduce the number of patients needed to assess the therapeutic effects of a drug candidate, without lowering the statistical power of the final approval decision, as measured by Type I and II error rates. As a result, therapeutic candidates can progress more quickly through the regulatory process and reach patients faster and at lower cost.

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