Now, 120 years later, the major clinical trials networks of the western world -- that is, the half a dozen or so of these groups funded by the U.S. National Institutes of Health (NIH) -- are set to carve up Africa, Asia and much of the developing world for the purpose of testing treatments, vaccines, microbicides and behavioral prevention approaches.
Of course, both the NIH and the investigators involved will scream that I am being singularly unfair: the new emphasis on clinical research on HIV/AIDS in the developing world will be a partnership between American investigators and their African, Asian, South American, and Caribbean counterparts and will bring much needed resources to these regions.
These clinical trials networks are getting ready to apply for funding, or "re-compete," for their next five-to-seven year cycle of federal support. Bureaucrats at the Division of AIDS are now furiously crafting a Request for Application (RFA) to guide those applying for the $400+ million in AIDS clinical research funding. The networks have been in existence for well over a decade and the scientists who lead them inhabit key positions in the world of AIDS research. Despite earnest invocations of partnership, the same group of U.S.-based researchers that has been in charge of clinical research on AIDS for many, many years will still be pulling the strings as their studies move to the global South (and they will not share or relinquish control easily).
While this stands as a moral outrage, it is a scientific one as well. There are key questions that need to be answered about treating HIV in the developing world concerning how to best use antiretroviral therapy in these settings, the impact of co-infections like tuberculosis and malaria, and best ways to deliver treatment where little health care infrastructure exists. All of these questions and the trials needed to answer them are far from the kind of high-tech, university-based studies that have been the focus of the American clinical research establishment. In fact, the researchers best positioned to develop a clinical research agenda for the developing world are those working there now.
The re-competition of the NIH's clinical trials networks is set to establish a new colonialism in AIDS research that is as unilateral as the administration's foreign policy. After cries of outrage from treatment activists, the Office of AIDS Research at NIH and its director Dr. Jack Whitescarver responded by bringing in a set of outside experts to draft some principles to guide their efforts. Initial drafts of these principles look promising, but the real problem lies at the Division of AIDS at the National Institute of Allergy and Infectious Diseases (NIAID) where deep parochialism, arrogance and lack of vision threaten to squander a precious opportunity to revamp this huge clinical research system.
So what is to be done? First, whether it wants to or not, DAIDS needs to ensure that researchers from the developing world have control over the scientific agenda of studies to be conducted in their countries. It simply isn't good enough to have "representation" from the developing world on decision-making committees of the major clinical trials networks -- this is tokenism. Protocol design, administration and evaluation for studies conducted in the developing world can and should be conducted in the developing world -- there is no reason it has to happen in Denver, Seattle, Baltimore or Bethesda.
Second, DAIDS should sequester a quarter or more of its annual clinical research budget for non-network-supported studies with a rapid review process. This would allow outside groups to apply for support to answer critical questions that the networks will not or cannot address. Indeed, there are some kinds of studies, particularly the operational research that will be vital to shaping the AIDS treatment programs of many developing countries, which standing networks are poorly suited to perform. This would also allow smaller, key studies to be performed without the onerous delays in protocol implementation that the existing networks are notorious for.
Third, DAIDS needs to ensure strong, external oversight of its clinical trials networks. The NIH Office of AIDS Research should be entrusted to establish an AIDS Clinical Research Advisory Group made up of leading researchers unaffiliated with funded networks and with strong representation from developing countries to provide guidance to the networks on a regular basis.
Clinical research on HIV/AIDS is one of the key engines for improving the treatment and prevention of HIV infection -- the way it is conducted, by whom and what is studied have tremendous implications for the millions of us living with HIV/AIDS and those at risk. There are some momentous choices to be made in Bethesda this summer. Perhaps the leaders at the Division of AIDS will finally wake up to the enormous responsibility they now hold in their hands.
Back to the GMHC Treatment Issues May/June 2004 contents page.