A potential therapeutic strategy for patients who respond (or have stable disease) on a fixed-
duration induction therapy is to receive maintenance therapy, typically given for a prolonged …

We review how overall survival (OS) comparisons should be interpreted with increasing
availability of effective therapies that can be given subsequently to the treatment assigned in …

Comparisons of post‐relapse survival (PRS) and post‐progression survival have been used
to measure efficacy in some cancer clinical trials. These comparisons are an attempt to …

An increasing number of putative anticancer targets and drugs have been identified with
many of these expected to be growth inhibitory. Clinical development of these agents in the …

Phase II oncologic clinical trials for agents that are mainly growth inhibitory and benefit only
a selected patient population are challenging. The randomized discontinuation trial design …

Purpose: Selecting an experimental arm for a Phase III trial is based on the results of Phase
II investigations. Historical results show that this paradigm leads to the failure of many …

Phase II trials serve an important role in oncologic drug development by screening single
agents or combinations of agents in a single disease entity for signs of efficacy that would …

Background: There is often a finite progression-free interval of time between one systemic
therapy and the next when treating patients with advanced cancer. While it appears that …

Time-to-event end points are the most frequent primary end points in phase III oncology
trials, both in the adjuvant and advanced settings. The evaluation of these end points is …

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 …