Trends in Clinical Research Including Asian American, Native Hawaiian, and Pacific Islander Participants Funded by the US National Institutes of Health, 1992 to 2018

1The landmark 1985 Report of the Secretary’s Task Force on Black and Minority Health (known as the Heckler Report) resulted in a national health focus on eliminating health disparities and concluded that Asian American, Native Hawaiian, and Pacific Islander (AA/NHPI) populations are healthier than all other racial/ethnic groups in the United States. The prevailing stereotype that AA/NHPI groups are model minority populations has resulted in data equity efforts negatively affecting AA/NHPI subgroups (eg, Vietnamese or Samoan). Data equity is the need for high-quality, disaggregated racial/ethnic data to capture disparities and underlying social factors associated with health needed to develop evidence-based solutions that inform public policies.

2Asian American, Native Hawaiian, and Pacific Islander populations represent more than 50 countries or cultures of origin and 100 different languages and are the fastest-growing racial/ethnic group in the United States., Data for AA/NHPI populations are typically grouped together, which can conflate or inflate the magnitude of health and health outcomes. For example, in aggregate, AA/NHPI adult rates of liver cancer incidence and mortality are double those of non-Hispanic white adults. However, when data are disaggregated, liver cancer incidence is 7 times higher and 9 times higher for Laotian men and women, respectively, compared with non-Hispanic white adults. Understanding the complexities of health by subgroup could be the difference between eliminating or worsening health disparities.,

3The health of AA/NHPI groups is further complicated when data are stratified by sociodemographic characteristics. In 2017, approximately half of AA/NHPI individuals were foreign born and recent immigrants entering the United States in 2000 or later. Asian American, Native Hawaiian, and Pacific Islander individuals were more likely to speak a language other than English compared with non-Hispanic white individuals. Despite the recognized heterogeneity across AA/NHPI subgroups, these populations remain understudied,,, and data collection, reporting, and dissemination issues,,, challenge the ability to understand health. Most federal databases are limited to simple distributions owing to small sample sizes for AA/NHPI groups. Furthermore, inconsistent implementation of racial/ethnic classifications and dearth of culturally appropriate instruments decrease our ability to understand exposures and health outcomes across subgroups.

4Between 1986 and 2000, Ghosh found that AA/NHPI participants were represented in 0.2% of all health-related grants from 7 federal agencies. Similarly, an average investment of 0.4% in AA/NHPI communities was found in the top 20 major US foundations. Taken together, there have been minimal financial investments in AA/NHPI populations by federal agencies and philanthropy, even though AA/NHPI individuals represent more than 5.0% of the total US population.

5During the past 2 decades, notable efforts by the federal government have emphasized reducing health disparities for AA/NHPI individuals., The National Institutes of Health (NIH) Revitalization Act of 1993, and Minority Health and Health Disparities Research and Education Act of 2000 established the National Institute on Minority Health and Health Disparities. Likewise, the NIH Health Disparities Strategic Plan and Budget prioritized eliminating health disparities in racial/ethnic minority populations. The 1997 Office of Management and Budget Directive 15 recognized AA/NHPI as 2 separate racial categories, and the Patient Protection and Affordable Care Act section 4302 expanded these data collection standards to include 7 AA and 4 NHPI subgroups., In 2009, Executive Order 13515 reestablished the Office of the White House Initiative on Asian Americans and Pacific Islanders that highlighted more AA/NHPI-focused investigations.

6Advancing an inclusive national agenda for AA/NHPI populations has become an intersecting priority for federal agencies., However, the impact of federal investments and legislation to ensure systematic processes and resources to eliminate health disparities in AA/NHPI groups is unclear. The purpose of this portfolio review is to examine the level of investment by the NIH that focused on clinical research in AA/NHPI populations.

7The NIH Research Portfolio Online Reporting Tools Expenditures and Results (RePORTER) system is an electronic database of federally funded projects dating from 1985 to the present and includes project information and abstracts. We focused on NIH grant programs because the agency is the largest funder of health research globally. Approval of this study was waived by the Oregon State University institutional review board because it did not involve human participants.

8We used NIH RePORTER to collect information on extramural NIH-funded clinical research projects conducted in the US and associated territories and funded between January 1, 1992, and December 31, 2018. The NIH defines clinical research as patient-oriented research, epidemiologic and behavioral studies, and outcomes and health services research. We defined unique projects as having the same grant number, which may include multiple years of funding. We excluded active projects because they have not completed the budget period or are projects with no-cost extensions. We included research project grants, centers, cooperative agreements, research career awards, training grants, and fellowships and performed an advanced text search for key words representing AA/NHPI countries or cultures of origin (eMethods in the Supplement).

9We exported projects matching the search criteria, screened project titles and terms for inclusion, and reviewed project abstracts for eligibility. We classified projects into 2 categories:

10AA/NHPI only, which includes only AA/NHPI participants, as grouped or disaggregated ethnicities (eg, project included Vietnamese and Chinese participants or Asian participants);

11AA/NHPI plus non-AA/NHPI, which includes AA/NHPI participants and additional racial/ethnic groups (eg, project included Asian, black or African American, and non-Hispanic white participants).

12Total AA/NHPI is the sum of the 2 categories. We excluded projects that did not fit the clinical research definition, did not explicitly include AA/NHPI participants, took place internationally, or had no project abstracts.

13We cataloged studies under specific criteria, including the primary target populations, AA/NHPI subgroups, health domain, and geographic region. Project health domains were coded using the NIH Research, Condition, and Disease Categorization (RCDC) system, which uses text data mining and NIH-defined terms to catalog projects into research areas. We coded whether projects were trans-NIH efforts (eg, funded by >1 of the NIH Institutes or Centers [ICs]) or funded under multiple funding opportunity announcements (FOAs). The first author (L.N.Đ.) identified the clinical research studies based on search criteria that were discussed with the last author (V.L.I.). We followed the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) protocol for the search strategy, study selection, and data extraction from project abstracts. The last author (V.L.I.) was consulted for study eligibility and categorization when necessary. The first author (L.N.Đ.) coded whether the FOAs specifically referenced AA/NHPI participants or health disparities populations. Geographic regions were based on NIH RePORTER regional grouping and US Census Bureau definitions.

14Descriptive analyses included NIH dollar investments over time, characteristics of AA/NHPI clinical research, and features of the funded organizations. We examined the proportions of AA/NHPI-related research using 2 denominators, total NIH expenditures and clinical research expenditures. We calculated the annual changes in funding amounts and new projects awarded between 1992 and 2018 using simple linear regression. We also compared funding amounts and projects awarded before 2000 and after 2000, to compare with the study period used by Ghosh. We defined statistical significance as P <.05. Data were managed in Microsoft Excel (Microsoft Corp) and we conducted statistical analysis using R statistical software version 3.5.0 (R Project for Statistical Computing).

15We obtained the total NIH expenditures from the NIH Office of Budget Mechanism Detail for Total NIH for fiscal years 1992 to 2018., Total NIH expenditures were defined as total research grants (not including small business innovation research/small business technology transfer grants) plus total research training. Clinical research expenditures for fiscal years 2008 to 2018 were obtained from the Estimates for Funding for Various RCDC.

16We identified 5460 records on NIH RePORTER based on our search criteria (Figure 1). After screening project titles and project terms, we removed 2637 duplicate records and reviewed 891 project abstracts for inclusion. We included 529 unique projects in this analysis.

17Total AA/NHPI projects were funded across 17 NIH ICs (Table 1). The top 5 funders collectively contributed almost 60% of the total funding dollars for AA/NHPI projects and were the National Cancer Institute ($231 584 664), National Institute on Aging ($108 365 124), National Heart, Lung, and Blood Institute ($67 232 910), National Institute on Minority Health and Health Disparities ($62 982 901), and National Institute on Mental Health ($60 072 779). The ICs awarding the greatest number of projects were the National Cancer Institute (n = 132), the National Institute on Mental Health (n = 62), the National Institute on Aging (n = 57), the National Institute of Child Health and Human Development (n = 48), and the National Institute of Nursing Research (n = 37). By funding mechanisms, the National Cancer Institute awarded the most research project grants (n = 102) and cooperative agreements (n = 14), the National Center for Research Resources awarded the most centers (n = 15), the National Institute on Mental Health awarded the most research career awards (n = 14), the National Institute of General Medical Sciences awarded the most training grants (n = 6), and the National Institute of Nursing Research awarded the most fellowships (n = 15).

18Total AA/NHPI projects were funded under 262 unique FOAs, in which 49 projects (9.3%) were trans-NIH efforts and 17 projects (3.2%) were funded under more than 1 FOA. Approximately 22.5% of the FOAs explicitly referenced AA/NHPI populations under the funding opportunity description and 29.4% of the FOAs referenced health disparities population terms (eTable 1 in the Supplement).

19Table 2 shows the allocation of NIH dollar amounts by funding mechanisms and grouping category. The NIH funded a total of $775 536 121 toward 529 research projects, with 60.8% of total AA/NHPI funding allocated to research project grants ($471 406 495), 18.3% to centers ($141 828 462), 15.8% to cooperative agreements ($122 809 956), and less than 5.1% to research career awards ($24 458 837), training grants ($10 821 202), and fellowships ($4 211 169). More than two-thirds of the total AA/NHPI projects awarded were research project grants (n = 360), followed by centers (n = 57), research career awards (n = 41), fellowships (n = 39), cooperative agreements (n = 25), and training grants (n = 7).

20Amounts of AA/NHPI-only funding were greater for overall research project grants, cooperative agreements, and fellowships but lower for center, career, and training grants compared with AA/NHPI plus non-AA/NHPI funding amounts. Projects that were AA/NHPI only received less in total funding dollars ($234 319 617) but had a greater mean funding per project ($1 354 449) compared with AA/NHPI plus non-AA/NHPI projects. Looking at R01 grants, the AA/NHPI-only R01 budget ($214 141 949) was less than the AA/NHPI plus non-AA/NHPI R01 budget ($217 973 811), but the mean per project was more for AA/NHPI-only R01s ($2 185 122). Mean project funding was greater for AA/NHPI only for research project grants ($1 574 372), centers ($3 399 835), and fellowships ($115 365) compared with AA/NHPI plus non-AA/NHPI research project grants ($1 267 844), centers ($1 995 453), and fellowships ($91 359).

21Table 3 shows the project health domains and funded organizations type and regional distribution. The most common health domains were cancer (n = 116), mental health (n = 74), cardiometabolic disease (n = 51), cardiovascular disease (n = 30), and substance abuse (n = 24).

22There were 161 unique grantee organizations funded. More than 76% of total AA/NHPI funding was concentrated in 5 organization types, including domestic higher education ($187 192 280), schools of medicine ($182 857 757), research institutes ($110 419 596), organized research units ($57 352 298), and schools of arts and sciences ($51 397 258). The greatest number of projects were awarded to schools of medicine (n = 128), followed by research institutes (n = 73), schools of arts and sciences (n = 64), domestic higher education (n = 59), and schools of nursing (n = 48).

23By geographic region, 63.5% of the total AA/NHPI funding amount ($492 415 443) and more than half of the total AA/NHPI projects (n = 267) were awarded to organizations located in the Western region, followed by 16.6% of the total AA/NHPI funding ($128 958 357) awarded to 107 projects in the Eastern region. More than 62.6% of the total AA/NHPI projects were conducted in 5 states, California (n = 170), Hawaii (n = 47), New York (n = 44), Washington (n = 35), and Illinois (n = 35), with more than 50% allocated to California ($316 509 458).

24Almost 60% of the total AA/NHPI projects (n = 303) mentioned an AA/NHPI subgroup (eg, the project abstract explicitly mentioned Vietnamese participants). More than 75.0% of AA/NHPI-only projects (n = 200) specified an AA/NHPI subgroup compared with 38.0% of AA/NHPI plus non-AA/NHPI projects (n = 103). Among AA/NHPI-only projects, the subgroups most represented were Chinese (n = 71), Korean (n = 42), Vietnamese (n = 37), Filipino (n = 21), and Japanese (n = 19) for AA participants, and Native Hawaiian (n = 18), Samoan (n = 7), Marshallese (n = 4), Chamorro (n = 3), and Tongan (n = 3) for NHPI participants. For AA/NHPI plus non-AA/NHPI projects, Chinese (n = 62), Filipino (n = 20), Japanese (n = 18), Native Hawaiian (n = 15), and Vietnamese (n = 11) populations were referenced most often.

25Figure 2A shows the dollar amounts for AA/NHPI clinical research grants over time. Total AA/NHPI dollars ($775 536 121) composed 0.17% of the overall NIH expenditures ($451 284 075 000) between 1992 and 2018, and 0.18% ($677 479 468) of the NIH research budget after 2000. In all, AA/NHPI-only and AA/NHPI plus non-AA/NHPI dollar amounts made up 0.10% ($362 547 841) and 0.09% ($314 931 627) of the total NIH expenditures after 2000, respectively (eTable 2 in the Supplement). There was a statistically significant positive trend in total AA/NHPI funding dollars between 1992 and 2018 (estimated dollar amount, $12 860 000; 95% CI, $9 215 000-$16 504 000; P <.001), but the proportion of the total NIH budget has only increased from 0.12% before 2000 to 0.18% after 2000, with no difference in funding before vs after 2000 (eTable 3 in the Supplement). Compared with funding before 2000, there was a statistically significant increase in funding amounts after 2000 for AA/NHPI-only projects (estimated dollar amount, $92 962 000; 95% CI, $13 756 000-$172 167 000; P =.02), while funding amounts for AA/NHPI plus non-AA/NHPI significantly decreased after 2000 (estimated dollar amount, −$115 265 000; 95% CI, −$183 009 000 to −$47 521 000; P <.001) (eTable 3 in the Supplement).

26Total AA/NHPI research constituted 0.38% of the clinical research budget in 2018 and made up 0.36% of the NIH clinical research budget between 2008 and 2018 (eTable 4 in the Supplement). Spending for AA/NHPI-only projects made up 0.20% of the clinical budget in 2018 and had an average of 0.21% over the same period.

27Figure 2B shows the number of new projects awarded over time. No statistically significant trend was observed in total new AA/NHPI projects awarded over time. There was a statistically significant increase in total AA/NHPI projects awarded after 2000 compared with projects awarded before 2000 (estimated number of projects, 9.89; 95% CI, 2.77-17.01 projects; P =.01) (eTable 5 in the Supplement). By grouping category, there was a statistically significant increase in projects awarded after 2000 for AA/NHPI only (estimated number of projects, 4.72; 95% CI, 0.65-8.79 projects; P =.02) and AA/NHPI plus non-AA/NHPI (estimated number of projects, 5.17; 95% CI, 0.06-10.27 projects; P =.05) groups.

28Despite federal legislation and initiatives prioritizing data disaggregation and advancing health disparities research, we found that 0.17% of the overall NIH budget was allocated to 529 AA/NHPI-related clinical research projects over 2 decades. Our findings match the study by Ghosh that found AA/NHPI individuals represented 0.2% of the total health-related federal expenditures. Since the Ghosh study, the number and amount of AA/NHPI-only grants increased, but they still accounted for only one-fifth of 1% of NIH’s clinical research budget. The funding allocated to total AA/NHPI research remained less than one half of a percent for both the overall NIH budget and clinical research budget. Furthermore, there was a lack of diversity in the investment in terms of ICs and geographical regions. More than half of the research funding was concentrated in 3 ICs, consistent with the leading causes of death for AA/NHPI individuals in the United States. Funding was concentrated in California and Hawaii, corresponding to the top states of residence for AA/NHPI individuals. Similar to prior reports,, negligible investment was seen toward states with the fastest-growing AA/NHPI populations. The current investment patterns, or lack thereof, could result in worsening health disparities in AA/NHPI populations because of prolonged disparate funding of health research.

29Minimal increases in inclusion of racial/ethnic minority participants across all NIH research have been reported. Enrollment for AA participants in extramural NIH-defined phase 3 clinical trials increased from 2.5% (n = 7451) in 2011 to 12.1% (n = 19 172) in 2016, while NHPI participants decreased from 0.3% (n = 1011) to 0.2% (n = 271) during the same period. This increase in clinical trial participation by AA participants did not translate to increased data disaggregation. We found that AA/NHPI populations continue to be classified as a homogeneous group and there was unequal representation of AA subgroups. Dishearteningly, the decline in NHPI participants enrolled in NIH clinical trials matched our findings. Native Hawaiian and Pacific Islander participants were almost absent from the grants found in our search.

30Treating AA/NHPI populations as homogeneous assumes cultural beliefs and experiences are the same, which could potentially influence and prolong misleading clinician stereotypes and unconscious biases about patients. Immigration- and acculturation-related factors influence English language proficiency, health and digital literacy, and preferences of clinical care and treatment. The magnitude of these factors varies across and within AA/NHPI subgroups, and differentially affects the generalizability of clinical research as well as the significance of downstream clinical applications. Disaggregated analyses have the potential to inform clinical and public health programs if significant differences are found between groups. Understanding cultural difference within AA/NHPI populations could emend the cycle of poor patient-clinician communication and patient health outcomes.

31Findings from our study have implications for future administrative and programmatic efforts, namely (1) intentional use of FOAs, (2) workforce diversity, (3) data disaggregation with data harmonization, and (4) access to data.

32One reason for poor investment by NIH in AA/NHPI research could be that investigators are not submitting grant applications focusing on these populations. Our research could not asses the number of applications submitted that included AA/NHPI populations. However, we reviewed FOAs and we could differentiate funded grants that were in response to a specific FOA. Approximately half of grants in this analysis (393 of 529) were linked to a FOA. However, less than a quarter of FOAs specifically referenced AA/NHPI populations and only one-third of the FOAs referenced health disparities populations. Our finding suggests that FOAs need to be more intentional in referencing health disparate populations.

33The low rate of funded research among AA/NHPI populations could be because of the low prevalence of AA/NHPI researchers. Our findings could not evaluate the race/ethnicity of principal investigators. However, only 5% of the total AA/NHPI funding was awarded to research career awards, training grants, and fellowships, but more than three-fifths of that amount was allocated to research project grants. Systematic challenges for minority investigators include mentoring differences, securing funding, and achieving academic tenure.,,,, For example, Ginther et al reported that Asian investigators were less likely to receive an R01 award on the first or second submission compared with their white counterparts. Enhancing investments in the research pipeline at the early career stages could improve the biomedical workforce diversity and could improve the number and success of funded research studies. In addition, improved workforce diversity could increase participation of AA/NHPI individuals in health research.,, Minority populations are more likely to understand and participate in research if they are able to identify or feel a connection with researchers.,,,,

34In our study, more AA/NHPI-only projects specified AA/NHPI subgroups compared with AA/NHPI plus non-AA/NHPI projects. This finding suggests that AA/NHPI-only projects may be prioritizing culturally appropriate inclusion and recruitment strategies as well as disaggregated data, while AA/NHPI plus non-AA/NHPI projects may focus more on studying a disease in general. More focused AA/NHPI research could improve the status of disaggregated data and accuracy of AA/NHPI health profiles, particularly if there is better harmonization of questionnaires and data collection protocols. For example, the Mediators of Atherosclerosis in South Asians Living in America (MASALA) study was modeled after the Multi-Ethnic Study of Atherosclerosis (MESA). Because MASALA and MESA had matching data collection protocols and collected disaggregated racial/ethnic data, the prevalence of diabetes is now comparable between specific subgroups of Asian individuals, Latino individuals, and white individuals.

35Federal agencies must provide public-use data files and reports by disaggregated race/ethnicity to improve transparency and evaluation of research priorities. Eliminating health disparities requires that there is sufficient AA/NHPI data to understand what is happening and to intervene in a meaningful way. Future studies should evaluate research rigor of funded projects, such as the proposed enrollment of racial/ethnic minority participants as comparison with enrollment reported in publications. Funding trends should be assessed to document whether they have kept pace with population growth and whether they are addressing and anticipating health disparities. Other federal agencies and philanthropic organizations should document their funding for AA/NHPI groups.

36This study has limitations. First, this study summarized extramural funding awarded through the NIH and does not include other federal agencies or philanthropy. Search queries focused on research project grants, training, and fellowships as funding mechanisms because they focus on investigator-initiated research. The applicability of our review is limited to the project information available on NIH RePORTER, so relevant projects may have been excluded during the screening and eligibility protocol.

37We do not know what proportion of NIH funding should be spent on racial/ethnic minority populations or what the research priorities should be. We assume that research funding in racial/ethnic minorities will lead to improved health outcomes because more disaggregated health data will improve our understanding of whether health disparities exist and result in evidence-based interventions for at-risk and high-risk AA/NHPI subgroups. Total AA/NHPI projects covered 10 of 11 Healthy People 2020 health disparities areas that report AA/NHPI data. However, it is ambiguous how much investment and how many projects are needed to reach the Healthy People 2020 goals, or when an arbitrary level of improved health has been achieved.

38In addition, information on the inclusion of racial/ethnic subgroups in clinical research are not publicly available. Minority health and health disparities funding data are available on the RCDC summary table, but do not follow the standardized RCDC process for annual estimates. The clinical research budget line is only available starting in 2008. The proportions may be underestimated for the total NIH expenditures (ie, this denominator includes nonhuman subjects research) and overestimated for clinical research expenditures (ie, this denominator may not have included secondary data analyses). We also reported comparisons between total funding amounts and project means for AA/NHPI only and AA/NHPI plus non-AA/NHPI; however, the more meaningful comparisons may be comparisons with NIH total funding amounts by grant mechanism and mean funding per NIH project, respectively.

39We found disproportionate long-term investments from the NIH to eliminating health disparities in AA/NHPI populations. Inclusion for these underrepresented populations in the federal agenda and disaggregated data allows for more useful data to reveal the health status of AA/NHPI subgroups and helps to dispel the model minority stereotype. Overt direction from federal entities, dedicated federal funds for health disparities research, and parallel efforts to increase diversity in the biomedical workforce will be critical to advance health equity. This portfolio review can be used to address underlying systematic barriers and inform future health disparity research opportunities.