Efficiency of study designs in diagnostic randomized clinical trials.

  title={Efficiency of study designs in diagnostic randomized clinical trials.},
  author={Bo Lu and Constantine Gatsonis},
  journal={Statistics in medicine},
  volume={32 9},
From the patients' management perspective, a good diagnostic test should contribute to both reflecting the true disease status and improving clinical outcomes. The diagnostic randomized clinical trial is designed to combine both diagnostic tests and therapeutic interventions. Evaluation of diagnostic tests is carried out with therapeutic outcomes as the primary endpoint rather than test accuracy. We lay out the probability framework for evaluating such trials. We compare two commonly referred… CONTINUE READING

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