The modern debate on whether—and why—physicians and hospitals can refuse patient or family demands for treatment on grounds of “futility” will be reaching its 20 anniversary this year (Blackhall, 1987). The early debate focused on the use of CPR, for good historical and clinical reasons, and CPR probably remains the primary target of hospital policy. But the reach of the arguments over futility...

BACKGROUND AND PURPOSE Most large, randomized phase III efficacy trials of therapeutic agents in ischemic stroke have failed to find treatment benefit. We determined whether some phase III studies could have been avoided if preceded by smaller single-arm phase II studies to evaluate the futility of proceeding to phase III. METHODS To provide examples of the application of phase II methodology...

In the editorial “The Evolution of Clinical Trials in Oncology: Defining Who Benefits from New Drugs Using Innovative Study Designs” [1], Goldberg et al. nicely discuss many changing aspects of clinical trial design in oncology. However, I believe their title is misleading. No study will define “who benefits” but only who might benefit. For example, human epidermal growth receptor 2 overexpress...

Background: Creatine and minocycline were prioritized for testing in Phase II clinical trials based on a systematic evaluation of potentially disease modifying compounds for Parkinson disease (PD). Objective: To test whether creatine and minocycline alter the course of early PD relative to a predetermined futility threshold for progression of PD in a randomized, double-blind, Phase II futility ...

Background: Creatine and minocycline were prioritized for testing in Phase II clinical trials based on a systematic evaluation of potentially disease modifying compounds for Parkinson disease (PD). Objective: To test whether creatine and minocycline alter the course of early PD relative to a predetermined futility threshold for progression of PD in a randomized, double-blind, Phase II futility ...