Next Steps on Refining the NIH HIV Clinical Research Enterprise

By Carl W. Dieffenbach, Director of the Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health

As 2018 unfolds, the National Institute of Allergy and Infectious Diseases (NIAID) continues to plan the future of HIV clinical trial research for the next decade. Every seven years, the National Institutes of Health (NIH) re-evaluates and competitively renews its funding for the HIV clinical research networks operating in the United States and internationally. By establishing a forward-looking agenda to guide this process, NIH is determining the focus and priorities of its HIV networks through 2027. 

In 2017, NIAID asked for your input on the future of HIV clinical research, and many individuals and organizations responded. I was especially heartened to hear from people concerned about future prevention and treatment options for themselves and others, advocates working around the world to advance research and health, seasoned and early career researchers, and many others who are part of the diverse research community. Thank you to all who shared thoughts with us.

As we have received feedback, we have considered new opinions and, where appropriate, made adjustments to respond to concerns. We heard views on the importance of continuing a robust pediatric research agenda, which remains a priority for NIH. We listened to expert opinions on the proposed structure of an HIV vaccine research network, describing the scientific and technical intricacies involved in this particular area of research. We heard from many individuals concerned about future research on prevention options for women, and for people for whom a daily pill or long-acting injectable may not be desired forms of prevention. An array of issues affecting multiple research areas were raised. We value this opportunity to hear new perspectives, learn and reflect on them, and engage with the community on issues that are important to all of us.

The HIV research community is large and diverse, with strong and sometimes contradictory voices. As in science, different analyses of the same data can yield conflicting conclusions. Ultimately, NIH must pursue a research agenda that relies on the best scientific evidence to reduce the burden of the pandemic, particularly for people disproportionately affected by HIV. This research must continue to be conducted in accordance with the highest bioethical and scientific standards. In addition, we seek to increase the efficiency and effectiveness of clinical trial operations to get the most from limited funding while always ensuring participant safety.

The current proposal for refining the HIV clinical research network was presented at the NIAID AIDS Research Advisory Committee (ARAC) on January 29; the proceedings can be viewed online. ARAC members and the audience heard presentations that outlined the proposed structure of seven Funding Opportunity Announcements (FOAs) on HIV prevention, pediatric, therapeutic, and vaccine networks; laboratory centers, statistical and data management centers; as well as the clinical trial units. Following the presentations, comments by several attendees were heard. The conversation was robust, reflecting the thoughtfulness and passion we have seen the research community express during the past year. When it came time for ARAC to vote, the nearly unanimous recommendation was to proceed with the current proposal.

Now, NIAID is preparing the FOAs based on the concepts presented at ARAC, taking into consideration valuable and insightful feedback received from the meeting. When the writing process is complete, the FOAs will be made public for fair and open competition in early calendar year 2019. Awards are expected to be made in late CY2020. Thank you again for your participation in this process to refine the HIV clinical research enterprise.

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