GFBR 2017: The Ethics of Alternative Clinical Trial Designs and Methods in Low- and Middle- Income Country Research
August 1, 2017
Alternative clinical trial designs and methods are increasingly being used in place of the conventional randomised controlled clinical trial (RCT) in low- and middle- income countries (LMICs). These approaches – including adaptive, cluster randomised and stepped wedge designs and controlled human infection models – offer a number of potential advantages, including accelerating vaccine or drug development and making the clinical trial process more socially acceptable. However, the ethical implications of these designs on risks and potential benefits to participants, consent, scientific rigour, trial efficiency (including study population size), have not been adequately addressed. These uncertainties are further compounded by current guidance which was largely written without special consideration of new trial designs, leaving researchers, research ethics committees and regulators with little support in how to evaluate, implement and run these often complex trials. There is a pressing need for the global bioethics and research community and regulators to find mutual ground for discussion and a shared understanding of the challenges and opportunities presented by these alternative approaches; only then will their full potential to address the health needs in LMICs be realised.
As part of the upcoming meeting, the GFBR is seeking case studies that bring attention to key ethical issues that have emerged when conducting alternative clinical trial designs and methods in LMIC settings. We will also be having panel sessions, including a panel on guidance and policy issues. We are seeking proposals that provide an overview and critique of existing guidance on alternative trial designs and methods and/or identify gaps in current guidance and propose solutions (e.g. design-specific guidance). We also welcome proposals that highlight the policy issues associated with the use of these designs and methods in a LMIC setting.
The GFBR is also seeking participants to attend the meeting, with places awarded on a competitive basis.