Sample size calculation for clinical trials in which entry criteria and outcomes are counts of events. ACIP Investigators. Asymptomatic Cardiac Ischemia Pilot.

@article{McMahon1994SampleSC,
  title={Sample size calculation for clinical trials in which entry criteria and outcomes are counts of events. ACIP Investigators. Asymptomatic Cardiac Ischemia Pilot.},
  author={Robert Patrick McMahon and Michael A Proschan and Nancy L. Geller and Peter H. Stone and George S Sopko},
  journal={Statistics in medicine},
  year={1994},
  volume={13 8},
  pages={859-70}
}
In many chronic diseases, therapy aims to prevent or reduce the frequency of episodes of a disease manifestation, for example cardiac ischaemic episodes or epileptic seizures. Entry criteria for clinical trials typically include a minimum number of episodes within a baseline period, and regression to the mean should be anticipated. The distribution of the number of episodes at follow-up, the statistical power for treatment comparisons, and the difficulty of recruitment will depend on the entry… CONTINUE READING