Wednesday, August 15, 2007

Communicating bad trial results to the media

An interesting article on SciDevNet called Trial practitioners must become media savvy drew my attention to this paper: South Africa's Experience of the Closure of the Cellulose Sulphate Microbicide Trial
In PLoS Medicine.

It is an interesting paper about the media reporting after the ceasing of a trial of a microbicide as a preventative measure for HIV in South Africa. Despite what looks like some fairly good efforts by the researchers to control the story, it escaped them and they report became overblown & misconstrued.

They given an excellent list of suggestions for the future of communication in these sorts of events:

* Emphasise community education.
* Explain and emphasise to the community that HIV seroconversion is the only way to measure effectiveness of new prevention technologies including microbicides (i.e., there are no surrogate markers of infection that can be used in trials).
* Educate the media and community about clinical trials, including regulatory procedures and good clinical practice guidelines followed by clinical trialists.
* Develop early drafts of press releases of all possible DSMC outcomes—positive, negative, and no effect—in partnership with local researchers and community representatives.
* Inform local ethics committees, drug regulatory authorities, and health authorities of trial outcome prior to press release.
* In drafting press releases, be sure to include the contribution of in-country investigators, community advisory boards, and other relevant bodies.
* Issue the press release in developing countries where the research is conducted. At the press conference, it is valuable to include the local principal investigator and representatives of the trial sponsor, ethics committee, and the local health authority.

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