The global forum on bioethics in research meeting, "ethics of alternative clinical trial designs and methods in low- and middle-income country research": emerging themes and outputs.

ABSTRACT: Alternative clinical trial designs and methods are increasingly being used in place of the conventional individually randomised controlled trial (RCT) in high-income and in low-income and middle-income country (LMIC) research. These approaches - including adaptive, cluster-randomised and stepped-wedge designs and controlled human infection models - offer a number of potential advantages, including being more efficient and making the clinical trial process more socially acceptable. However, these designs and methods are generally not familiar to researchers, research ethics committees and regulators and their ethical implications have not received sufficient international attention from the bioethics, research, and policymaking communities working together. The ethics of alternative clinica

SUBMITTER: Hunt A 

PROVIDER: S-EPMC6921436 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature