The AIDS Research Program of the National Institutes of Health (1991) / Chapter Skim
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The shaping and implementation of such a program will require a series of steps that are described in the remainder of this report. These steps should have several positive results: strengthened management structures and processes for planning, coordinating, evaluating, and reallocating the AIDS research activities supported by the various NIH components and for ensuring their quality and cost-effectiveness; fuller development of some promising research areas; an increased overall level of support for See Appendix D for a complete list of abbreviations and acronyms.
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, a national advisory council (the AIDS Program Advisory Committee) , an executive committee of senior program officials (the NIH AIDS Executive Committee)
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I-he situation calls not only for stronger program planning but for stronger evaluation efforts and close linking of planning and evaluation results to the budget allocation process. Recommendation 2.2: AIDS program evaluation processes should be strengthened and linked closely to planning and budgeting processes to ensure that, first, questions of the highest priority are addressed adequately at all times; second, all studies being supported are still relevant and are as productive and efficient as possible; and third, resources are redeployed, sometimes across institutes, in response to research advances and breakthroughs or as time and experience indicate that some programs are more and some less successful than others in achieving their goals.
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Recommendation 2.3: The AIDS Program Advisory Committee should take a larger role in providing bread policy advice and program oversight and should include among its activities the development of the five-year AIDS research plan and annual updates. It should also conduct an annual renew of the programs and budgets developed to implement the plan.
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ELEMENTS OF THE NIH AIDS RESEARCH PROGRAM In Chapter 2, the committee's main concern was to review the structures and processes for managing the NIH AIDS research program—how it is planned, implemented, coordinated, and evaluated to ensure that all high-priori scientific questions are being addressed without gaps or overlaps, that programs are well designed and effective and efficient in achieving their goals, and that administrative support by NIH is adequate. The committee believes these questions are especially pertinent at this time, as the program shifts to a long-term managerial mode in response to the size, complete, and endurance of the HIV/AIDS epidemic, the large size and completed of the NIH AIDS program itself, and the overall constraints on the federal budget.
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Vaccines Recent advances in HIV vaccine research give considerable cause for optimism about prospects for an HIV vaccine, although many scientific obstacles remain to be overcome. This progress, given the enonnous benefit of a successful vaccine for prevention of HIV infection, warrants vigorous expansion of the HIV vaccine program.
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S research, NIH should coordinate the research plans of the various categorical NIlI institutes investing in vaccine development with the long-term plans of the National Center for Research Resources for developing and supporting animal models. NIH officials and extramural researchers were unanimous in asserting that poor access by investigators to high-quality reagents has hindered HIV vaccine research.
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Recommendation 3.9: The NIH AIDS program should increase its support for behavioral research, especially for basic behavioral research (e.g., research designed to understand the etiology or underlying causes of behaviors and evaluate the effectiveness of interventions to modify particular health-related behaviors) on behaviors relevant to the transmission of HIV, including but not limited to human sexual development and practices and (in coordination with ADAMHA)
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long experience in developing therapies in collaboration with drug companies and academic health centers has provided valuable lessons for organizing the development and clinical testing of new AIDS drugs. The committee believes NIH should focus its AIDS-related drug development resources on promising drugs that would not otherwise be developed by the pharmaceutical industry, and on assistance for drug sponsors that do not possess adequate resources to complete the studies required for submission of an IND application.
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_ determination of the efficacy of zidovudine (AZT) in the treatment of children with AIDS; · establishment of a national clinical trials program capable of testing new anti-HIV and anti-OI therapeutic agents; recruitment of many talented investigators into AIDS clinical research; · extension of the use of ANT for persons with early and asymptomatic infection and a better understanding of the drug's most effective and safe dosage ranges; and · initiation of dozens of important clinical trials that promise to provide essential information about treatment with a wide array of antiviral and anti-OI drugs.
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The committee believes that NIH-~ndust~y collaborations are appropriate and can benefit the development of anti-HIV and anti-OI drugs. Recommendation 3.17: NIH should ensure maximum coordination of its clinical trials with the pharmaceutical industry by meeting regularly to resolve conflicts over rights to data ownership and access to patients and investigators at AIDS clinical trials unit (ACTU)
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's large pool of patients. The committee believes that the intramural clinical trials programs at NCI and NIAID possess excellent researchers and resources that have allowed them to achieve important advances in the development of new AIDS therapies.
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Recommendation 3.24: NIH should establish a mechanism for better coordination of extramural and intramural clinical trials and consider shifting more responsibility for phase 1 studies to the intramural program. Information Dissemination The extreme sense of urgency surrounding the results of AIDS clinical trials has placed great pressure on the agency to obtain and release usable trial data rapidly.
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(Research advances with implications for prevention, diagnosis, and treatment are raising new and urgent questions about early dissemination, which were addressed in the section on clinical trials [recommendations 3.25 and 3.263.) The committee commends this work but encourages NTH to solicit input from the
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Funding of AIDS Research The committee reviewed carefully the size and composition of the NIH AIDS budget, aware of a general perception that the epidemic is receding and that the current level of effort is adequate. The committee finds, however, that the epidemic of HIV infection and AIDS remains a severe global public health emergency that is causing a growing burden of illness and death and placing severe stresses on the nation's health care system.
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Recommendation 4.4: The NIH associate director for AIDS research and the AIDS Program Advisory Committee should renew all RFAs and RFPs for AIDS research to
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The committee endorses as well special efforts to solve problems specific to the AIDS program, such as recruitment and retention of medical officers in the NIH AIDS treatment research (clinical trials) program.
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This consolidation will facilitate communication between the intramural and extramural programs and coordination of the multiple institutes, centers, and divisions involved in AIDS research activities. The committee endorses NIH's effort to take a systematic, sustained approach to upgrading and maintaining the campus infrastructure, which will benefit the AIDS program as well as non-AIDS research.
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