Two-arm randomised futility trials: PD-stat - a futility trial of a potential neuroprotective treatment in people with Parkinson's disease

Two-arm randomised futility trials: PD-stat - a futility trial of a potential neuroprotective treatment in people with Parkinson's disease

Futility trials are efficient, early phase studies designed to eliminate potential interventions or treatments before moving into large and expensive, definitive phase III trials. In a futility trial, the null and alternative hypotheses are reversed in comparison with the usual superiority trial and are one-sided. The null hypothesis is that the intervention reaches or exceeds the required leve...

Futility stopping in clinical trials

Early stopping due to futility, also referred to as a go/nogo decision, during interim analysis has become an important feature of clinical trial designs. Current methods for futility stopping in literature are mostly based on conditional power or predictive power in conjunction with the theory of stochastic curtailment or group sequential design. They have certain drawbacks that have been note...

Medical futility: a futile concept?

A randomized, double-blind, futility clinical trial of creatine and minocycline in early Parkinson disease

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 ...

Medical futility treatment in intensive care units.

OBJECTIVE To investigate cases of potential medical futility treatment in intensive care unit (ICU). MATERIALS AND METHODS Retrospective review of 1567 charts of patients treated during the three-year period (2012 - 2014) in the ICU of the University Hospital Centre Split, Croatia, was conducted. More detailed analysis of the deceased patients' (n=429) charts was performed to identify cases o...