The ultimate objective of CE is to foster independent input into the research process by the community where it is conducted. However, CAB autonomy can be hard to achieve because reliance on the sponsor for funding and on researchers for information and training can contribute to a significant imbalance of power that is difficult for CABs to overcome. This is especially true in locations with no or limited experience with CE in clinical trials and/or a hierarchical social structure where civil society participation is not a regular practice.
Of the 13 STREAM sites, 11 had no or limited experience with CE in a TB trial and no pre-existing CAB. As a consequence, Sponsor involvement in CAB formation, CAB work planning and budgeting, and CAB capacity building was necessarily significant. This involvement likely reduced CAB independence and autonomy; however, the Sponsor concluded this was necessary to ensure CE activities were implemented, given the inexperience of some trial sites. In addition, in all but one case, funding for CE activities was funneled to CABs via the trial site, increasing CAB reliance on the study team. This was necessary because most CABs/CAB members were not separate legal entities or able to manage external donor funding.
To mitigate the impact of significant Sponsor involvement, an intensive CAB capacity building program was implemented, and CABs had significant freedom to choose and implement CE activities that responded to their local priorities and conditions. In addition, during the last year of CE activities, the Sponsor held a cross-site training series focused on longer-term CAB sustainability covering topics such as CAB integration into existing research structures and post-trial funding opportunities. Therefore, we are hopeful that STREAM’s investment in capacity and institution building will benefit future TB trials.