The utility of partial cross-over designs in early phase randomized prevention trials

Control Clin Trials. 2004 Oct;25(5):493-501. doi: 10.1016/j.cct.2004.07.005.


In this note, we outline the benefits of a partial cross-over design for a class of experiments where the interest is the cumulative effect of dose versus placebo. The goal of our design strategy is to answer several complex question efficiently in a phase II setting with a minimal number of assumptions with an eye towards planning a phase III study.

Publication types

  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Clinical Trials, Phase II as Topic
  • Cross-Over Studies*
  • Double-Blind Method
  • Humans
  • Randomized Controlled Trials as Topic*