Comparison between phase III randomized clinical trials and their preceeding phase II studies

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...

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...

Comparison of primary endpoints between publications, registries, and protocols of phase III cancer clinical trials

Background Decisions by leading journals to require trial registration and to make protocols of phase III randomized clinical trials (RCTs) publicly accessible were landmark events in clinical trial reporting. Materials and Methods We identified phase III cancer RCTs published between 2013 and 2015 in New England Journal of Medicine (NEJM), The Lancet, The lancet Oncology, JAMA and Journal of...

Design of Phase III Clinical Trials

Modeling Heterogeneity in Phase II Clinical Trials

Problem statement: The common assumption in non-randomized Phase II clinical trials is a homogeneous population with homogeneous response. This assumption is at odds with many trials today; a heterogeneous response due to the existence of subgroups. Approach: In order to examine the effects of heterogeneity on the trial outcome, a systematic platform is developed to quantify the range and class...