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

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 clinical trial designs and methods in LMIC research was chosen as a topic for the 2017 Global Forum on Bioethics in Research (GFBR). The meeting opened a global dialogue about this emerging issue in research ethics and gave voice to the LMIC perspective. It identified the need to take a multidisciplinary approach and to develop capacity amongst researchers and research ethics committees and regulators to propose, review and regulate these novel designs and methods. Building skills and infrastructure will empower researchers to choose from a broad range of designs and methods and adopt the most scientifically suitable, efficient, ethical and context-appropriate of these. The need for capacity development is most pressing from the LMIC perspective, where limited resources create an urgency to seek the most efficient trial design and method. The aim of this paper is to encourage broad debate about this complex area of research. By opening up this debate, GFBR aims to promote the appropriate and ethical use of novel designs and methods so their full potential to address the health needs in LMICs can be realised.