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The DURATIONS randomised trial design: Estimation targets, analysis methods and operating characteristics.

Matteo Quartagno1, James R Carpenter1, A Sarah Walker1

  • 1MRC Clinical Trials Unit, University College London Institute for Clinical Trials and Methodology, London, UK.

Clinical Trials (London, England)
|November 6, 2020
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Summary
This summary is machine-generated.

The bootstrap method is recommended for estimating optimal treatment durations in DURATIONS trials, offering reliable operating characteristics for power and type-1 error analysis in reducing treatment duration for bacterial infections and tuberculosis.

Keywords:
Durationsestimandestimation methodsoperating characteristics

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Area of Science:

  • Clinical Trial Design
  • Biostatistics
  • Pharmacometrics

Background:

  • Reducing treatment duration is crucial for tuberculosis and bacterial infections.
  • Standard non-inferiority trials have limitations.
  • The DURATIONS design randomizes patients to multiple duration arms to model duration-response curves.

Purpose of the Study:

  • To investigate the operating characteristics (type-1 and type-2 errors) of statistical methods for inference from the DURATIONS design's estimated curve.
  • To compare different methods for estimating the shortest non-inferior duration.
  • To explore generalizability to other estimation targets like risk ratios and event rates.

Main Methods:

  • Simulations were used to evaluate statistical methods.
  • Methods compared include model confidence bands, the delta method, and bootstrap.
  • Estimation targets included shortest non-inferior duration, absolute event rates, risk ratio, and curve gradient.

Main Results:

  • Bootstrap method demonstrated good operating characteristics for DURATIONS design-appropriate quantities (power, type-1 error).
  • Model confidence bands are not recommended.
  • The delta method showed inflated type-1 error in specific scenarios, especially when optimal duration approached randomized durations.

Conclusions:

  • The bootstrap method is reliable for estimating optimal durations in DURATIONS designs.
  • Researchers can confidently use bootstrap for designing trials to shorten treatment duration.
  • Bootstrap can estimate uncertainty for various estimation targets in DURATIONS trials.