Recent experiences with clinical trials closures (either scheduled or unexpected, due to unforeseen circumstances) have elicited a broad range of reactions from civil society groups and the media. When negative, these reactions can have a damaging impact on the conduct of concurrent and future trials.

At a Microbicides 2008 workshop, participants examined recent trial closure experiences to determine what supports would help people understand trial closures and their significance at the community level more clearly. They also explored the roles that advocates can play in helping to prevent rumor and mis-communication about trial results and research findings.

The participants at the session agreed that closure of a microbicide trial ahead of schedule is not, in itself, a failure. All past trials had contributed immensely to progress in the field. A balanced public view of trial results can be facilitated by: increasing the sense of community ownership of a trial; highlighting the importance of thorough safety trials for all potential candidates; assuring early and frequent reviews of unblinded trial data by Data Safety and Monitoring Boards (DSMBs); developing effective mechanisms for disseminating the DSMB recommendations within communities; and cultivating transparent and effective stakeholder engagement in the research process. The need to develop a true universal placebo for microbicide trials was also discussed.

Advocates have played significant roles in helping to address issues as the trials close. The international, regional and national advocacy communities have helped to assure continued interest in microbicide research, despite setbacks and seemingly negative news from the field. However, their ability to play this role could be greatly strengthened by building advocates’ scientific literacy and capacity. This would better prepared them to: serve as effective CAB members; engage actively with protocol development; and make targeted inputs into decisions about secondary trial endpoints and the standard of care provided at trial sites. The need for a dedicated funding windows to give smaller NGOs much-needed access to funding for capacity-building and other relevant relevant community work was also discussed, as was the need for independent community-level monitors (distinct from DSMBs), to assure transparency.

Advocates agrred that they are well situated to identify the steps needed to prevent misinformation which can erode community trust in the research enterprise because they are part of the communities they serve. They can also help to build trust between researchers and civil society stakeholders. Microbicide clinical trials can harness this potential by engaging community advocates early in the various clinical trial design and implementation

Morenike Ukpong and Anna Forbes