NIAID to establish intramural trial sites
Permanent funding will entice partners
The National Institutes of Health (NIH) has given the go-ahead to an ambitious project aimed at expanding the organization’s capacity to do research and clinical trials relating to TB, HIV, and malaria in developing countries, says Carole Heilman, PhD, director of the Division of Microbial and infectious Diseases for the NIH’s National Institute of Allergy and Infectious Diseases (NIAID).
The planned expansion will take the shape of either three or four new "International Centers of Excellence in Research" (ICER). The centers will be based in Uganda, Mali, and in one or two other as-yet-unnamed African nations.
Along with providing sites for trials and other research into the three public-health scourges, the centers will train in-country researchers, bring in laboratory and communication infrastructure, and provide intensive training for in-country clinicians and researchers, says Heilman.
Centers won’t have to reapply for funding
The ICERs (pronounced "icers") will be funded on a permanent basis, a feature that sharply distinguishes them from extramural projects funded by the NIH, such as Case Western Reserve University’s TB Research Unit (TBRU) in Uganda. The Case Western site, as well another smaller TB site in Brazil, must reapply for funding on a regular basis. The ICERs, by contrast, will essentially operate as permanently funded outposts of NIAID. That feature, along with their work force of in-country investigators and other highly trained staff, means they will be attractive to other potential collaborators, Heilman says.
TB experts inside and outside the NIH are hailing the announcement.
"We certainly welcome greater NIH involvement in this arena, and we are very excited about the prospect for collaboration," says Rick O’Brien, MD, chief of the research and evaluation branch of the Division of TB Elimination at the Centers for Disease Control and Prevention in Atlanta.
NIAID’s decision to expand its overseas intramural research capacity is important for TB research, says O’Brien. "It’s becoming harder and more costly to do TB clinical trials in the U.S. because patients are harder to find," he says. "It’s also harder for us to address the critical issues posed by HIV for TB treatment — again, because it’s harder to find HIV-infected patients here."
Ann Ginsberg, MD, PhD, chief of the NIH’s Respiratory Diseases Branch, agrees. "It will have a positive impact on TB in this country for two reasons," she says. "A growing percentage of TB cases here are among people of foreign birth, and that’s led to a consensus that we’ll never control the epidemic here until we control it in the rest of the world. Plus, it’s extremely hard to do efficacy trials here."
Though she declines to name specific dollar amounts, Heilman says the ICER project will be the primary beneficiary "of discretionary funds [at NIAID]."
Several events have led to the birth of the ICER concept, Heilman adds. "In the past, international and global research hasn’t been a top priority in the U.S.," she says. "Now we’re seeing the realization that global health is crucial to American interests — and not just from the perspective of public health, but in many other ways, including economic development and political stability."
In addition, the NIH has been working to define its role in contributing to the public health goals proposed at the past two G-8 summits. The agency has also worked to define its role in helping attain goals articulated by former President Bill Clinton in his May 2000 Millennial Vaccine Initiative.
The prototype for the ICER model is the NIH’s intramural site for malaria research in Mali, says Heilman. "It’s a great model, and one that’s very worthy of expansion," she says. "In Mali, we’ve spent a lot of time training investigators and building human capacity. Over the past 10 years, these researchers have become
recognized as top-notch by the international
scientific community. We’ve also put in a communication system and trained staff in good laboratory and clinical practices."
What makes the Mali model even more impressive is that the nation is the fourth-poorest country on earth. Despite its poverty, the government has evinced "a gritty determination and the strong belief that health care is important," she adds. Because the NIH is willing to commit permanent funding to the ICERs, it’s important that the countries chosen as sites express the same high level of commitment, she adds.
Case Western University’s TBRU site in Uganda will definitely be a key player in the ICER planned for that country, Heilman says. "On a recent site visit, we saw clearly that there are untapped opportunities for the TBRU," she says. "We will expand those opportunities."
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