Meta-analysis of randomized phase II trials to inform subsequent phase III decisions

Meta-analysis of randomized phase II trials to inform subsequent phase III decisions

BACKGROUND If multiple Phase II randomized trials exist then meta-analysis is favorable to increase statistical power and summarize the existing evidence about an intervention's effect in order to help inform Phase III decisions. We consider some statistical issues for meta-analysis of Phase II trials for this purpose, as motivated by a real example involving nine Phase II trials of bolus throm...

Author's response to reviews Title:Meta-analysis of randomised Phase II trials to inform subsequent Phase III decisions Authors:

Using meta-analysis of Phase II trials to predict Phase III trial results

Methods We consider a meta-analysis of nine randomised Phase II trials comparing the efficacy of two therapies for acute myocardial infarction. Results for four outcomes were collected: intracranial haemorrhage, stroke, reinfarction and total mortality. We apply univariate and multivariate random-effects meta-analysis methods, and use the obtained summary results to derive 95% prediction interv...

Design issues of randomized phase II trials and a proposal for phase II screening trials.

Future progress in improving cancer therapy can be expedited by better prioritization of new treatments for phase III evaluation. Historically, phase II trials have been key components in the prioritization process. There has been a long-standing interest in using phase II trials with randomization against a standard-treatment control arm or an additional experimental arm to provide greater ass...

Novel methodologic approaches to phase I, II, and III trials.