Journal
NATURE REVIEWS DRUG DISCOVERY
Volume 18, Issue 10, Pages 797-807Publisher
NATURE PUBLISHING GROUP
DOI: 10.1038/s41573-019-0034-3
Keywords
-
Funding
- Harvard/MIT Center for Regulatory Science
- University of Pittsburgh
- PREPARE consortium
- Berry Consultants
- REMAP-CAP
Ask authors/readers for more resources
Researchers, clinicians, policymakers and patients are increasingly interested in questions about therapeutic interventions that are difficult or costly to answer with traditional, free-standing, parallel-group randomized controlled trials (RCTs). Examples include scenarios in which there is a desire to compare multiple interventions, to generate separate effect estimates across subgroups of patients with distinct but related conditions or clinical features, or to minimize downtime between trials. In response, researchers have proposed new RCT designs such as adaptive platform trials (APTs), which are able to study multiple interventions in a disease or condition in a perpetual manner, with interventions entering and leaving the platform on the basis of a predefined decision algorithm. APTs offer innovations that could reshape clinical trials, and several APTs are now funded in various disease areas. With the aim of facilitating the use of APTs, here we review common features and issues that arise with such trials, and offer recommendations to promote best practices in their design, conduct, oversight and reporting.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available