Ethical research must be both relevant and acceptable to the community where it is conducted. Community stakeholders are uniquely placed to comment on whether a proposed trial addresses a question that is important to the community, whether the trial design and implementation plan conform to cultural norms, and how best to communicate trial results to ensure policy change. Therefore, it is important for sponsors to consult CABs (as community representatives) before, during, and after a trial to ensure the trial addresses the health priorities of the community; trial documentation and procedures are culturally appropriate; and community members are equipped to advocate for better programs and policies.
In common with many other regulatory trials, STREAM faced significant challenges involving CABs/community members at the design phase. Although input from the global TB CAB was solicited and incorporated, input from community members at trial sites could not be sought before the sponsor finalized the trial design with the US Food and Drug Administration (FDA). This is because US FDA interactions occurred before sites were selected and site initiation (including CE) began. There will be different challenges related to donor funding cycles and priorities at the other end of the research cycle – translation of results into improved programs and policies. Advocacy and policy change based on STREAM results will continue long after results are available and donor funding ends. As a consequence, community-led advocacy at STREAM locations – for example, to amend national guidelines to incorporate shortened regimens and ensure availability of bedaquiline at reasonable prices – can only take place if STREAM CABs/CAB members continue to operate independently after STREAM funding ends.