National Institutes Of Health Funding Research Articles

Distinguishing between translational science and translational research in CTSA pilot studies: A collaborative project across 12 CTSA hubs.

The institutions (i.e., hubs) making up the National Institutes of Health (NIH)-funded network of Clinical and Translational Science Awards (CTSAs) share a mission to turn observations into interventions to improve public health. Recently, the focus of the CTSAs has turned increasingly from translational research (TR) to translational science (TS). The current NIH Funding Opportunity Announcement (PAR-21-293) for CTSAs stipulates that pilot studies funded through the CTSAs must be "focused on understanding a scientific or operational principle underlying a step of the translational process with the goal of developing generalizable solutions to accelerate translational research." This new directive places Pilot Program administrators in the position of arbiters with the task of distinguishing between TR and TS projects. The purpose of this study was to explore the utility of a set of TS principles set forth by NCATS for distinguishing between TR and TS. Twelve CTSA hubs collaborated to generate a list of Translational Science Principles questions. Twenty-nine Pilot Program administrators used these questions to evaluate 26 CTSA-funded pilot studies. Factor analysis yielded three factors: Generalizability/Efficiency, Disruptive Innovation, and Team Science. The Generalizability/Efficiency factor explained the largest amount of variance in the questions and was significantly able to distinguish between projects that were verified as TS or TR (t = 6.92, p < .001) by an expert panel. The seven questions in this factor may be useful for informing deliberations regarding whether a study addresses a question that aligns with NCATS' vision of TS.

Bibliometric and social network analysis of a Clinical and Translational Resource awardee: An Oklahoma experience 2014-2021.

Social Network Analysis is a method of analyzing coauthorship networks or relationships through graph theory. Institutional Development Award (IDeA) Networks for Clinical and Translational Research (IDeA-CTR) was designed to expand the capability for clinical and translational research to enhance National Institutes of Health funding. All publications from a cohort of clinical and translational scientists in Oklahoma were collected through a PubMed search for 2014 through 2021 in October 2022. For this study's bibliometric portion, we pulled the citations from iCite in November of 2022. There were 2,391 articles published in 1,019 journals. The number of papers published by year increased from 56 in 2014 to 448 in 2021. The network had an average of 6.4 authors per paper, with this increasing by year from 5.3 in 2014 to 6.9 in 2021. The average journal impact factor for the overall network was 7.19, with a range from 0.08 to 202.73. The Oklahoma Shared Clinical and Translational Resources (OSCTR) network is a small world network with relatively weak ties. This study provides an overview of coauthorship in an IDeA-CTR collaboration. We show the growth and structure of coauthorship in OSCTR, highlighting the importance of understanding and fostering collaboration within research networks.

Training and Accompaniment Model for Expanding ADRD Research in LMICs – The Atlantic Fellows for Equity in Brain Health Experience

AbstractBackgroundOften, global health programs are designed to train individuals from low‐ and middle‐income countries (LMICs) with training provided in more resourced regions. Subsequently, the trainees return to their home community with limited additional resources. When research is funded, capacity‐building is rarely prioritized and partnership for core administrative and study management needs is absent. A program of ‘accompaniment’ where programs partner with trainees after their training period is less frequent and could alter the landscape of research capacity building for dementia.MethodsThe Atlantic Fellows for Equity in Brain Health program provides both a one‐year in‐residence learning experience and seeks to accompany fellows as they return to their home community. Resources and activities in the post‐training period include funding for small pilot projects, networking and community building, training in grants management, support for logistic and administrative activities related to grants, partnering with grant and manuscript writing and assistance with data collection and management.ResultsOver seven years, Atlantic Fellows have received 137 Pilots Awards ($25k each) for activities in 41 countries. Many of these awards serve as launching pads for future funding. For example, the Multi‐Partner Consortium for Dementia Research in Latin America (ReDLat) grew out of a Pilot awarded to an Atlantic Fellow from Latin America uniting 14 research centers across six Latin American countries aiming to identify the unique genetic and social determinants of health that drive Alzheimer’s disease and related dementias. Work is underway and includes prominent capacity building activities with more than $12M in committed from global partners. More than 1454 individuals have been enrolled. Eleven Atlantic Fellows are directly involved in the project. Other examples include work in Brazil that has now been transformed into US National Institutes of Health funding. New work is currently launched in East Africa leading to competitive research applications under review.ConclusionsAn intentional model of accompaniment can achieve substantial impact on dementia research in LMICs.

A multi-institutional study from the US ROPE consortium examining factors associated with endocrine surgery exposure for general surgery residents

BackgroundPrior analyses of general surgery resident case logs have indicated a decline in the number of endocrine procedures performed during residency. This study aimed to identify factors contributing to the endocrine operative experience of general surgery residents and compare those who matched in endocrine surgery fellowship with those who did not. MethodsWe analyzed the case log data of graduates from 18 general surgery residency programs in the US Resident Operative Experience Consortium over an 11-year period. ResultsOf the 1,240 residents we included, 17 (1%) matched into endocrine surgery fellowships. Those who matched treated more total endocrine cases, including more thyroid, parathyroid, and adrenal cases, than those who did not (81 vs 37, respectively, P < .01). Program-level factors associated with increased endocrine volume included endocrine-specific rotations (+10, confidence interval 8–12, P < .01), endocrine-trained faculty (+8, confidence interval 7–10, P < .01), and program co-location with otolaryngology residency (+5, confidence interval 2 –8, P < .01) or endocrine surgery fellowship (+4, confidence interval 2–6, P < .01). Factors associated with decreased endocrine volume included bottom 50th percentile in National Institute of Health funding (–10, confidence interval –12 to –8, P < .01) and endocrine-focused otolaryngologists (–3, confidence interval –4 to –1, P < .01). ConclusionSeveral characteristics are associated with a robust endocrine experience and pursuit of an endocrine surgery fellowship. Modifiable factors include optimizing the recruitment of dedicated endocrine surgeons and the inclusion of endocrine surgery rotations in general surgery residency.

Characteristics of Clinical Trials in Sepsis Registered in Clinicaltrials.Gov between September 2007 and June 2023- a Cross Sectional Analysis

Purpose: To perform an analysis of trends and characteristics of Sepsis studies registered in ClinicalTrials.gov (CTG). Methods: The clinical studies related to sepsis registered on ClinicalTrials.gov (CTG) from September 27, 2007 to June 30, 2023, were identified using Advanced Search feature in ClinicalTrials.gov. The search terms also included bloodstream infections and toxemia. Trial characteristics were assessed by relative frequency calculations. Odds ratio and 95% confidence intervals were determined for the key characteristics. Results: September 27, 2007 to June 30, 2023, a total of 3,88,228 studies were registered in CTG, Of these, around 0.68% (2,628 studies) were conducted for sepsis disease, There were 56.01% (1472 studies) interventional and 43.99% (1156) observational studies. While comparing the proportion of Interventional studies in sepsis to the overall studies registered in CTG it was found that the proportion of interventional studies in sepsis was lower (OR 0.39; 95 % CI: 0.3618 to 0.4224; P &amp;lt; 0.0001). On further assessment, the proportion of registry studies in sepsis was higher compared to overall studies registered in CTG (OR 1.73; 95 % CI: 0.3618 to 0.4224; P &amp;lt; 0.0001). In sepsis, a total of 438 studies (16.67%) received funding from the industry, while 142 studies (5.4%) were funded by the National Institute of Health (NIH) and other U.S Federal agencies (FA). Majority of the studies, 78.86% (485) were funded by all others, including individuals, universities, research organizations etc. The proportion of sepsis studies funded by the industry and the NIH and other FA were lower in comparison with the all studies registered in CTG, with the industry funding 28.91% and the NIH funding 7.36%. Of all registered studies. Out of ongoing 615 studies in sepsis, 13.82% (85) studies are funded by the industry, 8.29% (51) were funded by the NIH and other U.S Federal agencies, and 78.86% (485) studies are funded by all others. Interestingly, there was slight decrease in the proportion of ongoing studies (indicator of recent studies) funded by the industry in comparison with all registered studies for sepsis (13.82 % vs 16.67 %), however, this difference was not statistically significant (OR 0.8; 95 % CI 0.6239 to 1.0306 and P = 0.0846), However, there was a significant increase in the funding rates by NIH and FA (OR 1.58; 95 % CI 1.1350 to 2.2081 and P &amp;lt; 0.0001). Overall rates of studies funded by others remained similar between the all the sepsis studies and the ongoing sepsis studies. The proportion of early phase studies, phase 1 (OR 0.3627; 95 % CI: 0.3012 to 0.4367; P &amp;lt; 0.0001) and phase 2 (OR 0.6581; 95 % CI: 0.5800 to 0.7466; P &amp;lt; 0.0001) were significantly lower compared to all clinical studies registered in CTG. Interestingly, proportion of late- phase clinical studies, both phase 3 (OR 1.2154; 95 % CI: 1.0668 to 1.3846; P = 0.0034) and phase 4 (OR 1.1927; 95 % CI: 1.0668 to 1.3846; P = 0.0184) were significantly higher compared to all studies registered in CTG. Conclusion: There were fewer intervention trials in the context of sepsis when compared with all clinical studies registered in CTG. Additionally, funding from the industry and NIH and FA was also lower in sepsis studies compared to overall studies. Further, overtime proportion of the studies funded by industry is reduced though not statistically. Reflection of this is seen in low number of early phase studies. A detailed analysis of the studies with trends and outcomes will be discussed in the main article.

A 10 Year Analysis of Gender Distribution in National Institutes of Health Funding for Non-Malignant Hematology

Introduction: Historically, there has been an underrepresentation of women in the field of hematology. Consequently, this makes them less likely to receive academic research grants. Here, we present a ten year retrospective analysis of the Research Project Grants (R01) awarded by the National Institutes of Health (NIH) through the fiscal years of 2012-2022. The grants were categorized by various NIH agencies. This temporal analysis examines gender disparities under the field of non-malignant hematology research. Methods:Data was extracted for the fiscal years 2012-2022 focusing exclusively on R01 grants awarded and categorized by the various NIH agencies. Data was leveraged using the NIH RePORTER tool, Tidyverse, and janitor packages in R. The dataset incorporated key grant parameters such as grant ID, agency code, activity code, abstract text, project title, fiscal year, activity status, award amount, organization, and principal investigator's(PI) name. In order to distinguish a PI's gender, PI's first names were processed using the gender package in R, which provided a gender-wise distribution of recipients. For statistical analyses, proportions of females with accepted R01 grants were compared between 2012 to 2022; this proportion analysis was also done among each NIH agency. Further, linear regression and associated statistical tests were used to identify whether there was significant change in grants received by either gender over this time period. Results: A total of 250,031 R01 grants were awarded by the NIH during the fiscal years of 2012 to 2022. Females (n=82,152: 32.9% (95% CI 0.41-0.43) received fewer grants than males (n=167,879: 67.1%, (95% CI 0.50-0.55). Across 2012 to 2022, there was no significant change in R01 grants awarded among men (16,221 to 15,601, p-value= 0.52). In contrast, there was a significant difference for females in the R01 grants awarded across 2012 to 2022 (6,865 to 9,339, p-value &amp;lt;0.001). In 2012, the National Institute of General Medical Sciences (NIGMS), National Institute of Neurological Disorders and Stroke (NINDS), and National Institute of Biomedical Imaging and Bioengineering (NIBIB) awarded less than 25% of the total grants to females. By 2022, of all the agencies, the NBIB remained the agency with the most extensive gender gap with females being awarded only 23% of grants. In contrast, the National Institute of Minority Health and Disparities (NIMHD) and the National Institute of Nursing Research (NINR) were the only agencies in 2012 to award more grants to females with approximately 52% and 74% of grants respectively. In 2022, the NINR and NIHMD continued to show more grants awarded to females versus males. In addition to those agencies, by 2022, the National Institute of Child Health and Human Development(NICHD) and National Center for Complementary and Integrative Health (NCCIH) joined the NINR and NIHMD in awarding more than 50% of grants awarded to females that year. Conclusion: This analysis highlights continued gender disparity as only 33% of total R01 NIH grants were awarded to females during the fiscal years 2012-2022 in non-malignant hematologic research. Although, it is noted that while some agencies have made strides towards gender parity, others continue to have a significant gap. While this remains a systemic and multifaceted issue, identifying these areas of gender disparity will enable targeted efforts to bridge this gap and advance gender equality.

The Rich Get Richer: The Matthew Effect in Open Payments

IntroductionThe Matthew Effect refers to a pattern of accumulated advantage, specifically how social status can lead to increased wealth and recognition. The Physician Payments Sunshine Act of the Affordable Care Act requires industry payments and the affiliated hospital to be publicly available through the Open Payments Database (OPD). The US News and World Report (USNWR) publishes a ranking of best medical school (research) programs yearly. The Blue Ridge Institute for Medical Research (BRIMR) ranks medical schools annually by the amount of funding from the National Institutes of Health (NIH). Whether medical school–affiliated hospitals with higher social ranking and more NIH funding receive more industrial support is unknown. This study aims to evaluate the relationship between open payment of medical school–affiliated hospitals and USNWR and BRIMR ranking. MethodsWe performed a cross-sectional analysis of the OPD for the fiscal year of 2021. Hospital industry payment information was collected for affiliated hospitals in general and research categories. NIH funding data and program rankings were collected from BRIMR and USNWR, respectively. All data were collected for the fiscal year of 2021. The open payments of schools ranked in the top 50 for USNWR (n = 50) and BRIMR (n = 49) were compared to the schools not ranked in the top 50 using SPSS with chi-squared and Mann–Whitney U tests. A multivariate linear regression was performed to evaluate the association between open payments, USNWR ranking, and BRIMR ranking. ResultsA total of 91 medical schools were included in this study. The top 50 ranked medical schools by BRIMR were found to have a higher median of total open payment ($5,652,628 versus $2,558,372, P < 0.001), open payment in research ($4,707,297 versus $1,992,597, P = 0.003), and general open payment ($1,083,018 versus $392,045, P < 0.001). When ranked by USNWR, the top 50 ranked medical schools were found similarly to have a higher median of total open payment (P < 0.001), open payment in research (P < 0.001), and general open payment (P < 0.001). USNWR ranking was an independent predictor of more total open payment (Coefficient 0.016, 95% confidence interval 0.002-0.029, P = 0.026) and research open payment (coefficient 0.018, 95% confidence interval 0.002-0.034, P = 0.028). USNWR ranking was not found to predict general open payments. BRIMR ranking was not associated with open payment in total, research, or general. ConclusionsHospital open payments were associated with the social reputation of their medical schools. NIH funding was not associated with open payments. A Matthew effect exists in current industry payments to medical school–affiliated hospitals.

Scholarly Productivity of US Medical Schools Before and During the COVID-19 Pandemic.

The coronavirus disease 2019 pandemic profoundly disrupted scientific research but was accompanied by a rapid increase in biomedical research focused on this new disease. We aimed to study how the academic productivity of US medical schools changed during the pandemic and what structural characteristics of medical schools were associated with trends in scholarly publication. Annual totals of publications for each US Doctor of Medicine-granting medical school were extracted for 2019 to 2021 from the Scopus database, and schools were categorized a priori as experiencing a sustained increase in publications, a transient increase in publications, or no increase in publications. Bivariate tests compared school characteristics among these three groups. Of 139 Doctor of Medicine-granting medical schools, 79% experienced sustained growth in publications from 2019 to 2021, 6% experienced transient growth, and 14% experienced no growth. Sustained growth in publications was associated with being affiliated with a research-intensive university, larger faculty size, the presence of an Emergency Medicine residency, having higher baseline National Institutes of Health funding, and experiencing higher coronavirus disease 2019 infection rates in the local community during the early months of the pandemic. Among predominantly White institutions, a higher diversity of female faculty was associated with a higher likelihood of experiencing transient rather than sustained growth in publications. Our results demonstrate that scientific output increased during the pandemic at most medical schools, despite significant barriers to research experienced by individual investigators. Further attention is needed to enhance equity in research opportunities, considering diverging trends in productivity between more- and less-advantaged schools, however.

National Institutes of Health Funding Gaps for Principal Investigators

Early-stage and established investigators compete for a limited supply of funds from the National Institutes of Health (NIH). Regardless of their previous funding success, many principal investigators (PIs) encounter a funding gap in which they no longer receive ongoing funding from the NIH. To determine incidence rates of PI-level funding gaps, the mean funding gap length, and whether these 2 metrics are associated with previous funding success. This study was conducted using data from NIH RePORTER. Historical datafiles for fiscal year (FY) 2011 to FY 2021 were aggregated to generate 2 master datafiles for this period: all NIH awards and only R01 awards. PIs with no funding in FY 2011 or FY 2021 were removed. PIs were sorted by FY 2011 total funding amounts and grouped by quarter of amount. A total of 39 944 unique researchers were awarded 220 131 NIH awards, of which 103 753 were R01 awards. For all NIH awards, there was an overall linear increase from top quarter to bottom quarter in the percentage of PIs who had at least 1 year without funding (from 27% to 75%), percentage of these gap PIs who had at least 2 consecutive years without funding (from 56% to 68%), and mean maximum consecutive years without funding for gap PIs (2.2 years to 3.1 years). For only R01 awards, there was an overall linear increase from top quarter to bottom quarter in the percentage of PIs who had at least 1 year without funding (50% to 74%), percentage of gap PIs who had at least 2 consecutive years without funding (59% to 71%), and mean maximum consecutive years without funding for gap PIs (2.4 years to 3.1 years). In this cohort study of NIH-funded investigators, PIs with higher NIH funding were less likely to experience a funding gap. Additionally, when these PIs encountered a funding gap, this period without funding was shorter; however, among all PIs, funding gaps typically lasted 2 to 3 years. These associations were found inclusive of all NIH awards and when analysis was limited to only R01 awards. These findings may be useful to PIs and academic institutions as they prepare, structure, and project research resource allocations.

The Anesthesiology Physician-Scientist Pipeline: Current Status and Recommendations for Future Growth-An Initiative of the Anesthesia Research Council.

The limited number and diversity of resident physicians pursuing careers as physician-scientists in medicine has been a concern for many decades. The Anesthesia Research Council aimed to address the status of the anesthesiology physician-scientist pipeline, benchmarked against other medical specialties, and to develop strategic recommendations to sustain and expand the number and diversity of anesthesiology physician-scientists. The working group analyzed data from the Association of American Medical Colleges and the National Resident Matching Program to characterize the diversity and number of research-oriented residents from US and international allopathic medical schools entering 11 medical specialties from 2009 to 2019. Two surveys were developed to assess the research culture of anesthesiology departments. National Institutes of Health (NIH) funding information awarded to anesthesiology physician-scientists and departments was collected from NIH RePORTER and the Blue Ridge Medical Institute. Anesthesiology ranked eighth to tenth place of 11 medical specialties in the percent of "research-oriented" entering residents, defined as those with advanced degrees (Master's or PhDs) in addition to the MD degree or having published at least 3 research publications before residency. Anesthesiology ranked eighth of 11 specialties in the percent of entering residents who were women but ranked fourth of 11 specialties in the percent of entering residents who self-identified as belonging to an underrepresented group in medicine. There has been a 72% increase in both the total NIH funding awarded to anesthesiology departments and the number of NIH K-series mentored training grants (eg, K08 and K23) awarded to anesthesiology physician-scientists between 2015 and 2020. Recommendations for expanding the size and diversity of the anesthesiology physician-scientist pipeline included (1) developing strategies to increase the number of research intensive anesthesiology departments; (2) unifying the diverse programs among academic anesthesiology foundations and societies that seek to grow research in the specialty; (3) adjusting American Society of Anesthesiologists metrics of success to include the number of anesthesiology physician-scientists with extramural research support; (4) increasing the number of mentored awards from Foundation of Anesthesia Education and Research (FAER) and International Anesthesia Research Society (IARS); (5) supporting an organized and concerted effort to inform research-oriented medical students of the diverse research opportunities within anesthesiology should include the specialty being represented at the annual meetings of Medical Scientist Training Program (MSTP) students and the American Physician Scientist Association, as well as in institutional MSTP programs. The medical specialty of anesthesiology is defined by new discoveries and contributions to perioperative medicine which will only be sustained by a robust pipeline of anesthesiology physician-scientists.

Academic productivity and NIH funding for anesthesiology departmental chairs: A 15-year comparison

Study objectiveThis study evaluated whether there were improvements in the number of departmental National Institutes of Health (NIH) training grants and the academic productivity of departmental chairs in terms of NIH research funding and PubMed-cited publications when compared to chairs of the same departments in 2006. DesignEach chair was identified from the Society of Academic Associations of Academic Anesthesiology & Perioperative Medicine's Association of Academic Anesthesiology Chairs and entered into the NIH Research Portfolio Online Reporting Tools (RePORTER), PubMed, SCOPUS, and the National Provider Identifier Registry. MeasurementsThe number and funding amounts of training grants awarded to the department in 2010, 2015, and 2020 were obtained as well as the department's national ranking and total dollar amount for NIH funding in 2020. For the current chair cohort, total publications and m-quotient (h-index corrected for active research years) were recorded along with each chair's history of NIH grant funding. These data were compared to a previous study of anesthesiology chairs that reviewed funding and publications through 2006. Main resultsWe analyzed data from 100 academic departments of anesthesiology and compared their scholarly activity relative to data gathered in 2006. In 2020, 52 of 100 departments of anesthesiology had evidence of NIH funding. There were not statistically significant (P > 0.05) differences in grants funding obtained by chairs between 2006 and 2020 with the exception that more chairs in 2006 had program or center grants. Median publications for chairs significantly increased from 35 in 2006 to 55 in 2021 (IRR = 1.5, 95% CI = 1.2–2.0, P = 0.003). Nineteen percent of chairs were female, which did not significantly differ from the proportion of women in the 2006 paper (15%, χ2 = 0.57, df = 1, P = 0.452). Of the male chairs, 90% were professors whereas 63% of female chairs were professors (χ2 = 8.8, df = 1, P = 0.003). Female chairs had fewer publications than male chairs (IRR = 1.8, 95% CI = 1.2–1.8, P = 0.002); however, m-quotients were not significantly different between men and women (P = 0.602). ConclusionsWhen compared to 2006, department of anesthesiology chairs had more publications in 2021; however, NIH funding rates remained unchanged. The specialty had 19% female chairs, and those chairs had fewer publications than their male counterparts, though sex differences were attenuated using metrics that account for disparities in career length.

Academic career progression in AANS/CNS Spine Section award recipients.

The American Association of Neurological Surgeons (AANS)/Congress of Neurological Surgeons (CNS) Joint Spine Section awards highlight outstanding abstracts submitted to the AANS/CNS Section on Disorders of the Spine and Peripheral Nerves by trainees interested in spine surgery, although the academic trajectory of awardees has not been studied. The aim of this study was to assess the academic career progression of prior recipients of the Journalistic and Academic Neurosurgical Excellence (JANE), Mayfield, and Kuntz research awards. Prior JANE, Mayfield, and Kuntz award recipients were identified using awardee records accrued between 1984 and February 2022. Awardee sex, country of residence, specialty, subspecialty focus, and current academic appointment status (if applicable) were searched online. Awardee h-indices and number of peer-reviewed publications were assessed via Google Scholar profiles (or Scopus if unavailable) and PubMed, respectively. Receipt of federal research funding as principal investigator (PI) was determined using the websites of the National Institutes of Health, the National Science Foundation, and the Department of Defense Congressionally Directed Medical Research Programs. The abstract-to-publication rate was assessed. A total of 7 JANE awards, 57 Mayfield awards, and 149 Kuntz awards were identified. Of the JANE awardees, all recipients were male. Of the 4 unique JANE awardees who completed training, 2 (50.0%) held academic appointments at the time of the study. All of the JANE abstracts were published in peer-reviewed journals. The mean h-index of all JANE awardees was 28 and the mean number of publications was 126. None of the awardees have received federal research funding. Of the Mayfield awards, 98.2% were awarded to males. Of the 43 unique Mayfield awardees who completed training, 20 (46.5%) held faculty appointments at academic medical centers. All of the Mayfield abstracts since 2011 were published in peer-reviewed journals. The mean h-index of all Mayfield awardees was 26 and the mean number of publications was 82. Five Mayfield awardees received National Institutes of Health funding as PI, and 7 awardees received Department of Defense funding as PI. Of the Kuntz awards, 95.3% were awarded to males. Most awards were given to current residents and fellows (46.3%). Of the 55 unique Kuntz awardees who completed training, 31 (56.4%) held faculty appointments at academic medical centers. The abstract-to-publication rate of the total Kuntz abstracts was 70.5%. The mean h-index of all Kuntz awardees was 15 and the mean number of publications was 58. Five Kuntz awardees (3.4%) received federal research funding as PI. Many recipients of the JANE, Mayfield, and Kuntz Joint Spine Section awards have successfully translated award abstracts into peer-reviewed publications. Furthermore, approximately one-third of the awardees are active in academic neurosurgery, with some having secured federal research funding.

Including Community Partners in the Development and Adaptation of Intervention Strategies to Prevent Initiation or Escalation of Opioid Misuse.

Current literature lacks clear examples of how to engage with communities in the development of opioid misuse interventions for diverse populations and across various settings. The National Institutes of Health (NIH) Helping to End Addiction Long-term® Initiative (HEAL) Prevention Cooperative (HPC) research projects work collaboratively with communities to develop and adapt their opioid misuse interventions to increase both feasibility and sustainability. Ten HPC projects were selected to receive NIH funding and are required to have partnerships with communities where their intervention is being conducted. This paper applies the Centers for Disease Control and Prevention (CDC)-adapted Public Participation Framework to examine the levels of community engagement used by each of these 10 HPC projects (Clinical and Translational Science Awards Consortium Community Engagement Key Function Committee Task Force on the Principles of Community Engagement, 2015). Using this framework, this paper illustrates the range of community engagement approaches and levels that the HPC projects rely on to develop, adapt, and adopt opioid prevention interventions across diverse populations and settings. This paper also lays a foundation for future examinations of the role of community engagement in intervention implementation and effectiveness and the level of community engagement that is necessary to improve intervention effectiveness.

Establishment of a Private Foundation-Academic Partnership to Promote Careers of Early-Stage Investigators Examining the Influence of Sex and Gender on Health and Health Care.

Biological sex and gender-based constructs contribute significantly to the diversity of disease outcomes and treatment responses across the life course. To promote research considering sex and gender, the National Institutes of Health (NIH) Office of Research on Women's Health (ORWH) launched the Specialized Centers of Research Excellence (SCORE) on sex differences program. The Career Enhancement Core (CEC) of the Johns Hopkins SCORE on Sex and Age Differences in Immunity to Influenza (SADII) partnered with the Foundation for Gender-Specific Medicine, which matched NIH funding to support seed grants. Over 3 years we awarded 12 (10 were women faculty) seed grants to early-stage investigators. One year after the award, the seed grant awardees highlighted their progress, including publications, grant applications, and abstracts. All awardees noted challenges with their progress related to the COVID-19 pandemic and supply chain delays and shared suggestions for improving the programming of the CEC. They also highlighted the multiple ways the awards had helped them gain pilot data toward larger grants, build collaborative relationships, and present at the annual SCORE symposium. We describe a model and evidence supporting a private-academic collaboration to support the careers of early-stage investigators conducting research related to sex and gender.

Revealing the concealed: A tribute to Donald L. Morton, MD.

Donald L. Morton, MD, epitomized one of America's dream scenarios: a person evolving from the humblest of origins to become an international celebrity in his profession, leading the world in the discipline of surgical oncology. His pioneering accomplishments in various roles have been well documented. Scientists, clinicians, students, and patients benefited from his contributions to the management of malignant diseases, particularly melanoma. His many attributes in pursuing the goal to cure malignant diseases are well known. Browsing the scientific literature reveals an almost unmatched publication record and continuous National Institutes of Health funding. He revealed dozens of original concealed ideas, not least of which is the tumor-draining regional lymph node, now called the sentinel lymph node (SLN). When others gave up on the original promise of immunotherapy, he saw the future, the clinical promise which has lately materialized in the control of previously untreatable malignancies. He regarded the fellowship-training of more than 100 surgical oncologists as one of his biggest achievements. In this article, we celebrate the human side of a man with creative courage and far-reaching insight.

NIH funding for patents that contribute to market exclusivity of drugs approved 2010-2019 and the public interest protections of Bayh-Dole.

Previous studies have shown that National Institutes of Health (NIH) funding contributed >$187 billion for basic or applied research related to the 356 drugs approved 2010-2019. This analysis asks how much of this funding led to patents cited as providing market exclusivity, patents that would be subject to the provisions of the Bayh-Dole Act that promote and protect the public interest. The method involves identifying published research in PubMed related to the approved drugs (applied research) or their targets (basic research). NIH-funded projects (grants) funding these publications and patents arising from these projects were both identified in RePORT. Patents cited as providing market exclusivity were identified in DrugPatentWatch (which incorporates FDA Orange Book). NIH funded basic or applied research related to all 313 FDA-approved drugs 2010-2019 with at least one patent in DrugPatentWatch. This research comprised 350 thousand publications (9% applied research; 91% basic research) supported by 341 thousand fiscal years (project years) of NIH funding and $164 billion in NIH project year costs (17% applied research; 83% basic research). These NIH projects also produced 22,360 patents, 119 of which were cited in DrugPatentWatch as protecting 34/313 drugs. These patents were associated with 769 project years of NIH funding (0.23% total) and project year costs of $0.95 billion (0.59% total). Overall, only 1.5% of total NIH funding for applied research and 0.38% of total NIH funding for basic research was associated with patents in DrugPatentWatch. This analysis shows that very little of the NIH funding for research that contributes to new drug approvals leads to patents that provide market exclusivity and are subject to the provisions of the Bayh-Dole Act that promote the public interest in practical applications of the research, reasonable use and pricing, and a return on this public sector investment. This suggests that the Bayh-Dole Act is limited in its ability to protect the public interest in the pharmaceutical innovations driven by NIH-funded research.

Scholarly activity following National Institutes of Health Women’s Reproductive Health Research K12 training—a cohort study

National Institutes of Health funding to address basic reproductive health for common female conditions remains disproportionately low, in part because of low success rates of grant applications by obstetrician-gynecologists. This study aimed to evaluate the scholarly productivity of individuals supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development Women's Reproductive Health Research K12 career development award, created to advance careers of obstetrician-gynecologist physician-scientists. We performed a cohort study of individuals who completed at least 2 years of Women's Reproductive Health Research training by June 30, 2015, and had at least 5-year follow-up. Earliest training start date was December 1, 1998. Primary outcomes from public data sources (National Institutes of Health RePORTER, PubMed, iCite) were (1) number of total and R01 National Institutes of Health grants as principal investigator; (2) numbers of total and first and last author publications; and (3) median and highest publication impact factor measured by the relative citation ratio. Secondary outcomes from an email survey subcohort were total number of research grants, federally funded grants, and number of National Institutes of Health grants as coinvestigator; institutional promotions and academic appointments, national and National Institutes of Health leadership roles; and career and mentorship satisfaction. Outcomes were recorded at 5, 10, and 15 years postgraduation, and aggregate anonymized data were divided into 3 groups using Women's Reproductive Health Research completion dates: June 30 of 2005, 2010, and 2015. Temporal trends were assessed. Results were stratified by gender, number of awarded grant cycles (1-2 vs 3-4), and specialty type. Analyses used Fisher exact or Pearson chi-square tests, and Mantel-Haenszel tests of trend. The distribution of the cohort (N=178) by graduation completion date was: on or before June 30, 2005 (57 [32%]); July 1, 2005 to June 30, 2010 (60 [34%]); and July 1, 2010 to June 30, 2015 (61 [34%]). Most participants were female (112 [64%]) and maternal-fetal medicine trained (53 [30%]), followed by no fellowship (50 [28%]). Of the 178 participants, 72 (40%) received additional National Institutes of Health funding as a principal investigator, 45 (25%) received at least 1 R01, and 23 (13%) received 2 to 5 R01s. There were 52 (31%) scholars with >10 first author publications, 66 (39%) with >10 last author publications, and 108 (63%) with ≥25 publications. The highest relative citation ratio was a median of 8.07 (interquartile range, 4.20-15.16). There were 121 (71%) scholars with relative citation ratio ≥5, indicating >5-fold greater publication impact than that of other National Institutes of Health-funded scientists in similar areas of research. No differences by gender, institution, or temporal trends were observed. Of the full cohort, 69 (45.7%) responded to the survey; most self-identified as women (50 [73%]) and White (51 [74%]). Our findings suggest that the infrastructure provided by an institutional K award is an advantageous career development award mechanism for obstetrician-gynecologists, a group of predominantly women surgeons. It may serve as a corrective for the known inequities in National Institutes of Health funding by gender.

Spending on Phased Clinical Development of Approved Drugs by the US National Institutes of Health Compared With Industry

The launch of the Advanced Research Projects Agency for Health to advance new cures and address public concern regarding drug prices has raised questions about the roles of government and industry in drug development. To compare National Institutes of Health (NIH) spending on phased clinical development of approved drugs with that by industry. This cross-sectional study examined NIH funding for published research reporting the results of phased clinical trials of drugs approved between 2010 and 2019 and compared the findings with reported industry spending estimates. Data analysis was performed between May 2021 and August 2022 using PubMed data from January 1999 through October 2021 and NIH Research Portfolio Online Reporting Tools Expenditures and Results data from January 1999 through December 2020. Drugs approved between 2010 and 2019. National Institutes of Health funding for published research describing applied research on approved drugs, basic research on their biological targets, and phased clinical trials related to drugs approved between 2010 and 2019 were evaluated using Mann-Whitney U tests. All costs were inflation adjusted to 2018. National Institutes of Health funding for basic or applied research related to 386 of 387 drugs approved between 2010 and 2019 totaled $247.3 billion. Of this amount, $8.1 billion (3.3%) was related to phased clinical development. This funding contributed to 12 340 publications on phased clinical trial results involving 240 of 387 (62.0%) drugs. Average NIH spending was $33.8 million per drug, including $13.9 million per drug for phase 1, $22.2 million per drug for phase 2, and $12.9 million per drug for phase 3 trials. Spending by NIH on phased development represented 9.8% to 10.7% of estimated industry spending, including 24.6% to 25.3% of estimated phase 1, 21.4% to 23.2% of phase 2, and 3.7% to 4.3% of phase 3 costs. Considering 60 products for which estimated industry costs were publicly available, NIH spending on clinical trials was significantly lower than estimated industry spending (sum of averages, $54.9 million per drug; mean difference, $326.0 million; 95% CI, $235.6-$416.4 million; 2-tailed paired t test P < .001). More than 90% of NIH funding came through cooperative agreements or program projects and centers, while 3.3% of NIH funding came through investigator-initiated research projects. In this cross-sectional study, NIH funding for phased clinical development of drugs approved between 2010 and 2019 represented a small fraction of NIH spending on pharmaceutical innovation. This spending focused primarily on early-phase clinical trials and research capacity and was significantly less than estimated industry spending on clinical development. These results may inform the efficient allocation of government funding to advance pharmaceutical innovation.

Modeling the Adoption of 5760 Clinical Studies Into Practice Across 5 Surgical Specialties

IntroductionNo studies exist that explore the factors that influence the process of synthesizing new knowledge into perioperative standards of care and the operating room. We sought to model the adoption of clinical research into surgical practice and identify modifiable factors influencing the latency of this translation. MethodsWe created a data set comprised of all UpToDate articles between 2011 and 2020, sampled at 3-mo intervals, to explore how research is incorporated at the point-of-care (POC)—studying 5760 new references from 204 journals across five surgical specialties, compared to all uncited articles published during the same interval. UpToDate authors serve as specialty curators of the vast surgical literature, with an audience of more than a million clinicians in over 180 countries across 3200 institutions. Unlike society guidelines, UpToDate also provides the necessary granularity to quantify the time in bringing research to the bedside. Our main outcomes are citation rates and time-to-citation, split by specialty, journal, article type, and topics. We also model the influence of impact factor, geography, and funding and, finally, propose new impact indices to help with prioritizing surgical literature. ResultsWe highlight variation in adoption of clinical research by specialty. We show, despite representing a lower quality of evidence, surgical case reports are one of the most cited article types. Furthermore, most clinical trials (94%-100%) in surgical journals are never incorporated into POC reference lists. While few, pragmatic trials were the most likely to be cited of any article type in any surgical specialty (40%). Journal impact factor did not correlate with time-to-citation or proportion of articles cited in three of five surgical specialties, suggesting differences in how specialties synthesize/value research from specialty journals. Our two metrics, the Clinical Relevancy and Immediacy Indices, were defined to capture this impact/relevance to surgical practice. Of the five surgical subspecialties, gynecology references were >5-fold more likely to get cited, had a larger fraction of higher quality evidence incorporated, and demonstrated more success with POC adoption of practice guidelines. We also quantified the cost of translating research to surgical practice per specialty and generated maps that highlight institutions successful in translating research to the POC. The higher expenditure of National Institutes of Health funding in gynecology may reflect the cost of higher quality research per citation. ConclusionsUnderstanding translational latency is the first step to exposing blocks that slow the adoption of research into everyday surgical practice and to understanding why increasing research funding has not yielded comparative gains in surgical outcomes. Our approach reveals new methods to monitoring the efficiency of research investments and evaluating the efficacy of policies influencing the translation of research to surgical practice.

Limited number of spine surgeons among recipients of National Institutes of Health grants awarded for degenerative spine disease research.

Surgeon scientists remain underrepresented among recipients of National Institutes of Health (NIH) grants despite their unique ability to perform translational research. This study elucidates the portfolio of NIH grants awarded for degenerative spine diseases and the role of spine surgeons in this portfolio. The most common diagnoses and surgical procedures for degenerative spine diseases were queried on the NIH Research Portfolio Online Reporting Tools Expenditures and Results (RePORTER) database (2011-2021). Total NIH funding was extracted for 20 additional clinical areas and compound annual growth rates (CAGRs) were calculated. A retrospective cohort study of principal investigators (PIs) was conducted. NIH grants and funding totals were extracted and compared to those from other clinical areas. The total NIH research budget increased from $31 to $43 billion over the 10-year period (CAGR 3.4%). A total of 273 unique grants equaling $91 million (CAGR 0%) were awarded for degenerative spine diseases. Diabetes ($11.8 billion, CAGR 0%), obesity ($10.6 billion, CAGR 3%), and chronic pain ($5.6 billion, CAGR 7%) received the most funding. Most NIH funding for degenerative spine disease research was awarded through the R01 (66%) and R44 (8%) grant mechanisms. The National Institute of Arthritis and Musculoskeletal and Skin Diseases awarded the most NIH funding (64%). Departments of orthopedic surgery were awarded the most funding (32%). NIH funding supported clinical (28%), translational (37%), and basic science (35%) research. Disease mechanisms (58%), imaging modalities (20%), and emerging technologies (16%) received the most funding. Nineteen spine surgeons were identified as PIs (16%). There were no significant differences in NIH funding totals by PI demographic and academic characteristics (p > 0.05)-except for full professors, who had the most NIH funding (p = 0.007) and highest h-index values (p < 0.001). Few spine surgeons receive NIH grants for degenerative spine disease research. Future opportunities may exist for spine surgeons to collaborate in identified areas of clinical interest. Additional strategies are needed to increase NIH funding in spine surgery.