Communities must seize the initiative and collaborate with governments and researchers in developing vaccine trials, according to Ronaldo Mussauer de Lima, who addressed Tuesday's bridging session on overcoming obstacles to human trials. Political, economic, ethical, technical, human and social barriers must be addressed, and solutions found by both sponsoring and host countries, before trials may proceed.

Using vaccine trials as examples, de Lima noted, the question of whether placebos should be used raises ethical concerns, but a lack of a placebo arm could adversely affect study design. Another thorny issue is withholding post-exposure prophylaxis to participants of vaccine trials. Doing so is ethically unacceptable, and not doing so would confound the results of the trial. Sponsor and host countries must reach consensus on these issues, as well as such questions as who should be able to veto a trial, or whether treatment should be provided to participants who contract HIV during its course.

NGOs can help increase community commitment to vaccine trials, de Lima said, through providing education and information, as well as by attending international vaccine planning workshops to glean the best, most up-to-date information. When the public or governments see trial participants as mere guinea pigs, NGOs can help foster understanding of the trial process, de Lima added. Governments themselves can facilitate trials through political and financial support, and through sponsoring national meetings to bring key players together. In the end, de Lima stressed, governments, researchers and communities from both the North and the South must work as proactive team players, to bring urgently-needed vaccine trials to the places they are most needed.

this story can also be found in The Bridge, the onsite print newspaper

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