Closing Evidence Gaps in Clinical Prevention (2022) / Chapter Skim
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3 Clinical Prevention Research Enterprise
3 Clinical Prevention Research Enterprise
Pages 43-64
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This chapter reviews the important role the National Institutes of Health (NIH) serves in funding research relevant to the USPSTF, the contributions of other research funders, and the role of researchers.
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In addition, there are collaborative research teams consisting of intramural investigators and extramural researchers from multiple institutions and organizations. NIH has a multi-layered process for developing its funding priorities (see Box 3-1)
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Study sections can be either Standing Study Sections or special emphasis panels targeting a specific request for applications. NIH staff experts manage study sections.
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• Used to support a discrete, specified, circumscribed research project • NIH's most commonly used grant program • No specific dollar limit unless specified in funding opportunity announcement (FOA) • Advance permission required for $500K or more (direct costs)
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in an area representing their specific interests and competencies • Used when substantial programmatic involvement is anticipated between the awarding institute and center • One of many types of cooperative agreements • No specific dollar limit unless specified in FOA P01 Research Program Project Grant • Support for integrated, multi-project research projects involving a number of independent investigators who share knowledge and common resources • Each project contributes or is directly related to the common theme of the total research effort, thus forming a system of research activities and projects directed toward a well-defined research program goal • Specific dollar limit unless specified in FOA continued
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TABLE 3-2 Comparison of Grants and Contracts Grant Contract Assistance mechanism to support Legally binding agreement to acquire research for the public good goods or services for the direct use or benefit of the government Peer review of broad criteria Award based on peer review of stated evaluation factors, including technical criteria Limited government oversight and More government oversight and control control Reports Deliverables SOURCES: Adapted from NIH, 2016a; OER, 2020b. An NIH summary of funding by grant mechanism from 2011 to 2020 (excluding supplemental COVID-19 appropriations)
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Overall, more than 90 percent of 2016 prevention research was funded through the extramural research program, and approximately 14 percent was spent on clinical trials. The author noted challenges to
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Funding of U.S. Preventive Services Task Force– Relevant Clinical Prevention Research A recent analysis indicates that NIH is the largest single funder of the evidence cited in USPSTF reviews (Villani et al., 2018)
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Additional analysis showed that for the NIH-supported studies determined to be "key" for closing nine evidence gaps, three used contract mechanisms, three used only R grants, and three used a combination of funding, including intramural research funding. The Role of the Office of Disease Prevention ODP sits in the Division of Program Coordination, Planning, and Strategic Initiatives in the Office of the Director (Murray, 2020)
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Relevant categories for activities include the following: • active grants • active contracts • active Funding Opportunity Announcements • intramural research projects • meetings, workshops, and conferences • publications with new evidence • collaborations such as interagency agreements and committee or task force memberships A summary of 2018–2019 current activities documented in the 2020 I statement survey is found in Figure 3-1 and Table 3-3. For the 26 I statements included in the survey, 22 ICs report activities in 2018 and 2019.
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It is also important that studies on screening and interventions for cognitive impairment report harms and reasons for attrition of trial participants. I Statements Results at a Glance 2018–2019 Current Activities 2018 2019 Survey Summary 832 797 Grants 22 ICs 22 ICs 22 Participating ICs FOAs 249 194 26 I Statements 17 ICs 17 ICs Contracts 29 29 3 ICs 3 ICs Intramural Research 41 41 Other Projects 3 ICs 4 ICs Collaborations 2018 2019 Recent Meetings, Workshops, 17 24 Inter-Agency 1 1 5 ICs 6 ICs Agreements 1 ICs 1 ICs Conferences Publications with New 109 250 Scientific Interest 17 18 12 ICs 14 ICs Group Membership 5 ICs 5 ICs Evidence FIGURE 3-1 2020 I statement survey summary.
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A review of the listed RO1s suggests that research that was considered aligned with the I statement research needs ranges from "Olfactory Receptors for Semiochemical Detection in the Main Olfactory Epithelium" (3 RO1 DC014253-04) to "The UCSF Brain Health Assessment for the Detection of Cognitive Impairment Among Diverse Populations in Primary Care" (UG3NS105557)
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The committee hopes its taxonomy and the recommendations for its use, as described in Chapters 4 and 5, respectively, will offer a structured approach to categorizing research needs. OTHER CLINICAL PREVENTION RESEARCH FUNDERS While NIH is the single largest funder of biomedical research in the United States, other funders have an important role to play in clinical prevention research.
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. The Cancer Prevention and Control Research Network includes eight PRCs that conduct research on the "the dissemination and implementation of evidence-based programs proven to increase cancer prevention and control.
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. These 9 million records may be useful for addressing certain evidence gaps.
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For example, NIH has sponsored studies of how real-life factors, such as physician performance and patient adherence, influence the effectiveness of colonoscopy and fecal immunochemical testing in large-scale programs for colorectal cancer screening. NIH's Health Care Systems Research Collaboratory is another large-scale effort that engages organizations including clinics and hospitals in pragmatic clinical trials, aiming to generate real-world evidence on benefits and risks of treatment options (NIH, 2018a)
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. For example, in 2018 the American Cancer Society reported expenses of almost $148 million toward cancer research, second only to NIH (ACA, 2019; McKenzie et al., 2018)
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Such a team may require multiple institutions to include the researchers best equipped to design and conduct a study that generates the needed evidence. The inclusion of multiple institutions may also be needed to address evidence gaps in specific populations, such as racial/ethnic minorities and/or persons at high risk for the condition.
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Presented on March 16, 2021, at Meeting 4 of the Committee on Addressing Evidence Gaps in Clinical Prevention. https://www.nationalacademies.org/event/03-16-2021/addressing-evidence-gaps-in clinical-prevention-committee-meeting-session-2 (accessed November 2, 2021)
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2020. Closing evidence gaps in clinical prevention: A perspective from the NIH.
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2020a. NIH activities related to "insufficient evidence" statements of the US Preventive Services Task Force: Results from the 2020 annual survey of institutes, centers, and offices.
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