The Stroke Hyperglycemia Insulin Network Effort (SHINE) trial: an adaptive trial design case study.

ABSTRACT:

Background

The 'Adaptive Designs Accelerating Promising Trials into Treatments (ADAPT-IT)' project is a collaborative effort supported by the National Institutes of Health (NIH) and United States Food & Drug Administration (FDA) to explore how adaptive clinical trial design might improve the evaluation of drugs and medical devices. ADAPT-IT uses the National Institute of Neurologic Disorders & Stroke-supported Neurological Emergencies Treatment Trials (NETT) network as a 'laboratory' in which to study the development of adaptive clinical trial designs in the confirmatory setting. The Stroke Hyperglycemia Insulin Network Effort (SHINE) trial was selected for funding by the NIH-NINDS at the start of ADAPT-IT and is currently an ongoing phase III trial of tight glucose control in hype

SUBMITTER: Connor JT 

PROVIDER: S-EPMC4352277 | biostudies-literature | 2015 Mar

REPOSITORIES: biostudies-literature