Assumptions of Expected Benefits in Randomized Phase III Trials Evaluating Systemic Treatments for Cancer
Background In designing phase III randomized clinical
trials (RCTs), the expected magnitude of the benefit of the experimental
therapy
(δ) determines the number of patients required
and the number of person-years of follow-up. We conducted a systematic
review
to evaluate how reliably δ approximates the
observed benefit (B) in RCTs that evaluated cancer treatment.
Conclusions Investigators consistently make overly
optimistic assumptions regarding treatment benefits when designing RCTs.
Attempts
to reduce the number of negative RCTs should
focus on more realistic estimations of δ. Increased use of interim
analyses,
certain adaptive trial designs, and better
biological characterization of patients are potential ways of mitigating
this problem.
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