Input throughout Research Cycle

Research will be more relevant and acceptable if CABs/community members have input throughout the research cycle.

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.

Even when the clinical trial has ended, CE still continues and paves the way for other studies. CABs have experience in advocacy and can influence policy change, assist improving the lives of participants, show how research can be done in our community, and [eliminate] stigma.

STREAM CAB Member

Recommended best practices

Foster CAB involvement and sustainability across the research cycle through the following measures:

  • Invite CAB members to be part of local institutions involved in research agenda-setting

  • Invite CAB members to be members of research ethics committees

  • Donors should fund CE before a trial begins so that local community input can be sought as part of trial design

  • The sponsor should seek input from existing CABs as part of the design/protocol writing process. At a minimum, invite Global TB CAB input on the relevance and design of multisite TB trials before finalization with central regulators (e.g., the FDA or EMA)

  • A results dissemination plan should be developed by the sponsor, PIs, and CABs to ensure trial results are accessible to participants and community members

  • Develop capacity for advocacy by CABs

  • Develop capacity of CABs to receive and manage non-trial funding to enable CE activities to continue “between” trials