The GFBR will hold a two-day meeting in Bangkok, Thailand, on 28-29 November 2017 on the theme of “the ethics of alternative clinical trial designs and methods in low- and middle- income country research”.
Alternative clinical trial designs and methods are increasingly being used in place of the conventional randomised controlled clinical trial 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, 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.
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 and proposals to participate in a panel on guidance and policy issues.
The GFBR is also seeking participants to attend the meeting, with places awarded on a competitive basis.
Full details on how to make an application are available on the GFBR website. The deadline for applications is 21.00 BST on 30 May 2017.