23.2: Communication before and during the trial

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We have emphasized, in other chapters, the importance of adequate preparation before starting a trial. A very important aspect of these preparations includes meetings with community leaders, community advisory boards (CABs), and public meetings involving potential trial participants to explain fully the purposes of the trial and what it will involve. There should be ample time allocated at these meetings for questions, and indeed suggestions from those in the local community may lead to changes in the trial plan. It is also crucial to obtain permission from local and national officials for the conduct of the trial and to allocate sufficient time for discussions with those officials, who may also suggest modifications to the trial. Ideally, there will be representation from local and/or national officials on the trial steering committee, which is a good way of keeping them in touch and being able to call upon their advice at all stages of the trial.

Once the trial has started, to ensure the continuing collaboration from the trial participants, those in the community in which the trial is being conducted will need both information on the progress of the trial and the opportunity to comment throughout the trial. There will also be a need to keep the local health and government administration informed of activities. At a minimum, local and national officials should receive communication at least once a year; some may need this much more frequently (also see Chapters 7 and 9).

It is very important that any problems which are encountered during the conduct of the trial are rapidly identified by the trial investigators, and immediate steps are taken to make any necessary modifications to trial procedures and to explain to trial participants and community officials the reasons for any changes. Problems which are dealt with quickly are less likely to endanger the continued conduct of the trial than problems which are ignored for too long, with effective action either being delayed or not initiated. Regular meetings with the CAB should be a good conduit for early recognition of problems or issues being raised by trial participants or other members of the community.