Abstract
Why most randomized phase II cervical cancer chemoprevention trials are uninformative: lessons for the future.
Highlights
Title Why most randomized phase II cervical cancer chemoprevention trials are uninformative: lessons for the future
Factors that need to be considered in the design of cervical chemoprevention trials are as follows: the natural history of the disease in the absence of any intervention, the optimal range of anticipated clinical response to the randomly assigned intervention, and the validity and predictiveness of the primary and secondary outcome measures [14,15,16]
The likelihood that phase II cervical chemoprevention trials will be uninformative can be minimized with careful attention to critical features of study design: enrollment of a sufficient number of patients to permit the study to reveal differences in response rates; careful selection of the type and dose of chemopreventive agent, based on results from preclinical studies and phase I and IIa clinical trials; accurate classification of patients’ disease status, both at enrollment and at study end; and selection of appropriate primary and secondary outcome measures
Summary
Title Why most randomized phase II cervical cancer chemoprevention trials are uninformative: lessons for the future. Why Most Randomized Phase II Cervical Cancer Chemoprevention Trials are Uninformative: Lessons for the Future
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