Open and Honest Communication

Meaningful CE requires regular, open and honest communication between CABs and PIs/Sponsor.

In any clinical trial, researchers have important knowledge and information that the community stakeholders do not, and the same is equally true for community stakeholders. Researchers understand the disease and the trial, but community stakeholders understand whether communities and participants think the trial is relevant and acceptable to the community. Therefore, to optimize trial implementation and impact, there must be regular and open two-way communication between the study team and the community. This will also build trust between researchers and community members, which will have important long-term benefits for future research.

Ensuring regular and open communication is not always easy, particularly if stakeholder roles and responsibilities are unclear. In addition, variations in cultures and norms across sites and countries add complexity to establishing a uniform trial communication plan. For study team members, who are already very busy, informing community members about trial progress is sometimes seen as a burden, without obvious benefits. As well, researchers can be concerned about sharing confidential information with CABs and community members.

Knowledge and literacy about community engagement in research increased among medical staff and TB people. Trust [on] both sides was increased.

STREAM CAB Member

In STREAM, all sites held regular (usually semi-annual) general CE meetings as a mechanism to update key stakeholders, including STREAM CABs, about trial progress. However, a number of CABs preferred more frequent updates, which sometimes did not occur. In addition, the scope of information PIs were willing to share was sometimes circumscribed. For example, at one site, the protocol for the trial was not shared with the CAB due to confidentiality concerns, even though it was publicly available. 

In addition, quarterly meetings between CABs and the study team took place at most sites. It was hoped those meetings would be a forum for study teams to learn from CAB members about community suggestions for improving trial implementation and acceptability. Our experience, however, was that CAB/community input was both solicited and given less frequently than we would have liked. It is likely this resulted from limited study team buy-in to community involvement, limited community experience with clinical trials, and cultural norms.

Recommended best practices

Build institutions and processes that ensure regular and open two-way communications between researchers and CAB/community members through the following measures:

  • Before the trial begins, a communications plan should be developed and agreed by the sponsor, PI, and CAB setting out how and when trial information will be shared

  • The sponsor should encourage study teams to seek out CAB input on trial implementation challenges and protocol amendments

  • The sponsor should ensure sites implement at least quarterly meetings between study teams and CABs

  • CAB coordinators should be regularly informed of study progress and invited to the annual investigators’ meetings and other sponsor/researcher meetings where important design/implementation decisions are made. CABs are a key stakeholder entitled to trial updates whose input is needed

  • The sponsor should provide clear guidance to PIs regarding which trial documents can (and should) be shared with CAB members