Over the course of the past two decades the National Institute of Allergy and Infectious Diseases (NIAID) has developed an extensive set of networks to conduct clinical trials related to HIV/AIDS. These networks have helped to develop effective treatments for AIDS, identify strategies to prevent mother-to-child transmission, and expand the proven methods for preventing acquisition of the virus.
During the past 18 months the leadership at NIAID has been actively discussing whether it might be possible to leverage this extensive infrastructure, which has been developed with AIDS-appropriated dollars, for the purpose of expanding our clinical trials capacity for infectious diseases other than HIV. Following a series of consultations with members of the infectious diseases community, NIAID announced that when we re-compete the HIV/AIDS networks in 2013 we will also issue an RFA for a non-HIV infectious diseases “leadership group” that will be responsible for developing a clinical trials research agenda (to be paid for with non-AIDS dollars) that will be implemented in part by using the existing clinical trial infrastructure originally built for HIV/AIDS and related research. In addition, it is anticipated that non-HIV infectious diseases clinical research that might emanate from the Leadership Group would also utilize other clinical trial infrastructure available to them. NIAID has scheduled a town hall meeting on March 7, 2011, with the original intent of soliciting input from the infectious diseases community about the most important issues that should be incorporated in this research agenda.
Over the past two months NIAID has received a great deal of feedback regarding our proposed plans. First, we have heard that many are not clear on the definition of a non-HIV infectious diseases “leadership group” since this is not something that NIAID has used before within the non-HIV community. Second, some have expressed concern that it seems inconceivable that the entire non-HIV infectious diseases research agenda could be incorporated in a single leadership group while the NIAID Division of AIDS has announced that it will have five separate leadership groups for HIV/AIDS alone. Overwhelmingly, we have heard the sentiment that it is impossible for the infectious diseases community to define a research agenda that encompasses more than 290 pathogens in multiple diverse patient populations. As we have listened to this feedback, it has become apparent that we should more explicitly define the purpose of the March 7 town hall meeting in order to address these concerns.
The first thing that we need to make clear is that it is not our intent that a new infectious diseases leadership group will be the sole mechanism for conducting clinical research on non-HIV infectious diseases. Importantly, it is not meant to represent “leadership” for the entire infectious diseases research agenda. It will provide leadership for a restricted component of the broader infectious diseases research agenda. Therefore, on March 7th we plan to review some of the roughly $250 million dollars worth of clinical research that is currently supported by the NIAID Division of Microbiology and Infectious Diseases and outline how the new initiative will provide an additional mechanism for conducting infectious diseases clinical research using, out of practical necessity, a restricted component of a broader infectious diseases research agenda using a multi-site network.
Second, as mentioned above, it has not been our intent to have the clinical research agenda of the new leadership group encompass every aspect of all infectious diseases. Rather, we have been actively soliciting opinions about what the highest priorities are. The feedback that we have received about priorities has been remarkably consistent. So much so that we can now indicate that the primary responsibility of the new leadership group will be to develop and implement a strategic series of clinical trials to address bacterial antibiotic resistance. In addition, we would want this leadership group to have the potential and capability to respond rapidly to emerging infectious diseases (such as an outbreak of SARS or pandemic influenza). We will reiterate these priorities at the March 7th meeting and look forward to feedback from those who attend. Given the budgetary constraints at NIAID, it does not seem possible to expand the scope of the research agenda beyond these relatively narrow limits at this time. However, as resources become available in the future, we envision holding additional consultations with the community about other research priorities that might be implemented within this leadership group, or through additional infectious diseases leadership groups with other interests and areas of expertise.
Third, it is clear that we need to spend some of the time on March 7th defining what we mean by a “leadership group”. In part we will do this by describing how the leadership groups funded by the NIAID Division of AIDS have functioned in the past, although it is not essential that a non-HIV infectious diseases group conform exactly to this model. What we are ultimately looking for is a team of experts who can, in cooperation with NIAID staff, design and implement a strategic research agenda, not just a single clinical trial, that comprehensively addresses the clinical research priorities in the areas of bacterial antibiotic resistance and emerging infectious diseases.
We appreciate the lively and productive interactions that we at NIAID have had with the infectious diseases community thus far. We look forward to continuing this dialog on March 7th and in the future meetings.