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March 28, 2008Clinical Trials

A predictive probability design for phase II cancer clinical trials

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Authors

DLDiane D. LiuThe University of Texas MD Anderson Cancer Center

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Implication

Methodology study demonstrates earlier trial termination for inefficacious cancer therapies, highlighting enhanced flexibility and reduced patient burden.

Key Points

  • Develop an adaptable phase II cancer trial design using Bayesian predictive probability that preserves rigorous statistical properties while allowing continuous patient monitoring.
  • Constructed a Bayesian predictive probability design incorporating minimax criteria to guide early trial termination.
  • Implemented a three-dimensional search algorithm to determine optimal design parameters for type I and type II error control.
  • Evaluated operating characteristics and performance under design deviations using exact computation and simulation studies.
  • Strictly controlled type I and type II error rates while enabling continuous outcome evaluation instead of rigid multi-stage checkpoints.
  • Yielded earlier termination and lower expected sample sizes under the null hypothesis when an experimental regimen proved ineffective.
  • Demonstrated robust operating characteristics when trial conduct deviated from original design specifications.

Cite This Study

Diane D. Liu (2008) studied this question.

synapsesocial.com/papers/6a8ba80298aeeda2ff892cd0https://doi.org/10.1177/1740774508089279
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Predictive Probability Early Termination Plans For Phase II Clinical Trials1979 · 143 citations
  2. 2Optimal flexible designs in phase II clinical trials1998 · 123 citations
  3. 3Optimal three-stage designs for phase II cancer clinical trials1997 · 140 citations
  4. 4Bayesian two‐stage designs for phase II clinical trials2002 · 100 citations
  5. 5Practical Bayesian Guidelines for Phase IIB Clinical Trials1994 · 250 citations