A multi-source adaptive platform design for testing sequential combinatorial therapeutic strategies.

ABSTRACT: Traditional paradigms for clinical translation are challenged in settings where multiple contemporaneous therapeutic strategies have been identified as potentially beneficial. Platform trials have emerged as an approach for sequentially comparing multiple trials using a single protocol. The Ebola virus disease outbreak in West Africa represents one recent example which utilized a platform design. Specifically, the PREVAIL II master protocol sequentially tested new combinations of therapies against the concurrent, optimal standard of care (oSOC) strategy. Once a treatment demonstrated sufficient evidence of benefit, the treatment was added to the oSOC for all future comparisons (denoted as segments throughout the manuscript). In the interest of avoiding bias stemming from population drift,

SUBMITTER: Kaizer AM 

PROVIDER: S-EPMC6560363 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature