Assessing outcomes in prostate cancer clinical trials: A twenty-first century tower of babel
Clinical Trials, Phase II as Topic
Outcome assessment policies are highly variable in phase 2 studies of castration-resistant prostate cancer patients, despite published guidelines designed to standardize authentication of disease progression. The estimated error in PFS can exceed 6 weeks per cycle, exclusively because of variations in the assessment schedules. Comparisons of PFS times from different studies must be made with circumspection.