9.6 Summary

This chapter reviews various types of adaptive-randomization designs in clinical trials. When used appropriately, adaptive designs may improve the efficiency and reduce the cost of a trial. Also, the information from the recruited patients can be maximally utilized, and the risk to the patients can be substantially reduced.
However, in practice, randomized trials are still dominated by the conventional fixed-randomization scheme due to the following concerns:
  • Patients may not be balanced on certain covariates, especially those with possible time trends.
  • Hypothesis tests during interim monitoring and at the trial completion are unconventional and difficult.
  • Delayed outcomes may affect the practical implementation of ...

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