Academic Medical Product Development: An Emerging Alliance of Technology Transfer Organizations and the CTSA

To bring the benefits of science more quickly to patient care, the NIH National Center Advancing Translational Sciences (NCATS) supports programs that enhance the development, testing, and implementation of new medical products and procedures. The NCATS clinical and translational science award (CTSA) program is central to that mission; creating an academic home for clinical and translational science and supporting those involved in the discovery and development of new health‐related inventions. The technology transfer Offices (TTO) of CTSA‐funded universities can be important partners in the development process; facilitating the transfer of medical research to the commercial sector for further development and ultimately, distribution to patients. The Aggregating Intellectual Property (IP) Working Group (AWG) of the CTSA public private partnerships key function committee (PPP‐KFC) developed a survey to explore how CTSA‐funded institutions currently interface with their respective TTOs to support medical product development. The results suggest a range of relationships across institutions; approximately half have formal collaborative programs, but only a few have well‐connected programs. Models of collaborations are described and provided as examples of successful CTSA/TTO partnerships that have increased the value of health‐related inventions as measured by follow‐on funding and industry involvement; either as a consulting partner or licensee.     

The CTSA Mentored Career Development Program: Supporting the Careers of Child Health Investigators

Training translational scientists is a priority of the Clinical and Translational Science Award (CTSA) consortium. Objectives: 1) Describe the landscape of CTSA Mentored Research Career Development Awards (CDA) and 2) evaluate participation and outcomes of child health investigators in these programs. Design: Survey of the CTSA Child Health Oversight Committee (CC‐CHOC) and review of nonresponders'' CTSA Websites. Results: Thirty‐two of 53 CC‐CHOC members (60%) responded and all nonresponder Websites were reviewed. Institutions supported 1,166 CDA positions from 2006 to 2011, with 134 awarded to child health investigators (11.5%). Respondents reported a mean of 29.8 KL2 positions (95% CI 17.5–42.2) during their award period, with a mean of 2.8 (95% CI 1.8–3.8) awarded to child health investigators. The proportion of child health awardees varied from 0% to 50% across institutions. We identified 45 subsequent National Institutes of Health (NIH) awards to the 134 child health investigators (34%). Conclusions: The CTSA program contributes substantially to training the next generation of translational investigators. One‐third of child health investigators obtained subsequent NIH awards in the short follow‐up period demonstrating success of the CTSA CDA programs. Child health investigators are represented variably across the consortium. Pediatric institutions can partner with the CTSA program to further support training child health investigators.     

The Quantitative Evaluation of the Clinical and Translational Science Awards (CTSA) Program Based on Science Mapping and Scientometric Analysis

The Clinical and Translational Science Awards (CTSA) program is one of the most important initiatives in translational medical funding. The quantitative evaluation of the efficiency and performance of the CTSA program has a significant referential meaning for the decision making of global translational medical funding. Using science mapping and scientometric analytic tools, this study quantitatively analyzed the scientific articles funded by the CTSA program. The results of the study showed that the quantitative productivities of the CTSA program had a stable increase since 2008. In addition, the emerging trends of the research funded by the CTSA program covered clinical and basic medical research fields. The academic benefits from the CTSA program were assisting its members to build a robust academic home for the Clinical and Translational Science and to attract other financial support. This study provided a quantitative evaluation of the CTSA program based on science mapping and scientometric analysis. Further research is required to compare and optimize other quantitative methods and to integrate various research results.     

A comparative analysis of National Institutes of Health research support for emergency medicine – 2008 to 2017

ObjectivesWe sought to compare National Institutes of Health (NIH) funding received by Emergency Medicine (EM) to the specialties of Family Medicine, Neurology, Orthopedics, Pediatrics and Psychiatry over the 10-year period from 2008 to 2017.MethodsThe NIH database of both submitted and funded NIH applications were queried and crossed with the departmental affiliation of the principal investigator. Research Grants were defined by the following activity codes: R, P, M, S, K, U (excluding UC6), DP1, DP2, DP3, DP4, DP5, D42 and G12. Derived data were further analyzed using information from the Association of American Medical Colleges to determine the relationship between the number of awards and the size of respective teaching and research faculty.ResultsFrom 2008 to 2017, there were a total of 14,676 funded grants across included specialties with total monetary support of $6.002 billion. Of these funded grants, 250 (1.7%) were from EM principal investigators which corresponded to total support of $89,453,635 (1.5% of overall dollars). There was an increase in total support after 2012 in EM, however when compared to the other specialties, EM investigators submitted relatively fewer grants and awarded grants were funded by a wider distribution of NIH Institutes and Centers (ICs).ConclusionsCompared to other select specialties, EM investigators accounted for a small proportion of grants submitted and funded over the past decade. Though findings illustrate promising trends, to foster success, more submitted grant applications are needed from within EM along with systematic approaches to support faculty members in their pursuit of NIH funding.     

Clinical research at a crossroads: the NIH roadmap.

As a result of the NIH investment in biomedical research, over the past 30 years we have seen many great advances impacting the health of our nation which have been fostered by the effective translation of scientific advances. However, rising costs for both research and health care mean that the NIH must make strategic decisions that maximize the return on its investment. Because treating end-stage disease is so costly, both personally and financially, learning how to pre-empt illness through molecular knowledge and behavioral interventions is the only viable strategy for maintaining the nation's health in the coming years. In order to speed scientific discovery and its efficient translation to patient care, the NIH developed the Roadmap for Biomedical Research. The Roadmap provides an incubator space for funding innovative programs to address a panoply of scientific challenges and has engendered a new culture of cooperation among researchers seeking new avenues for collaboration. An important feature of the Roadmap is the Clinical and Translational Science Awards (CTSA). The program's goals are to eliminate growing barriers between clinical and basic research, to address the increasing complexities involved in conducting clinical research, and to help institutions nationwide create an academic home for clinical and translational science. By adopting a strong strategic vision now, the NIH will be able to stand at the ready as future challenges and opportunities emerge. In keeping with our mission, the NIH's current and future actions will be defined by the requirements of the scientific community and the public health needs of the nation.     

Developing the Translational Research Workforce: A Pilot Study of Common Metrics for Evaluating the Clinical and Translational Award KL2 Program

Purpose

This pilot study describes the career development programs (i.e., NIH KL2 awards) across five Clinical and Translational Science Award (CTSA) institutions within the University of California (UC) system, and examines the feasibility of a set of common metrics for evaluating early outcomes.

Methods

A survey of program administrators provided data related to the institutional environment within which each KL2 program was implemented. Application and progress report data yielded a combined data set that characterized KL2 awardees, their initial productivity, and early career outcomes.

Results

The pilot project demonstrated the feasibility of aggregating common metrics data across multiple institutions. The data indicated that KL2 awardees were an accomplished set of investigators, both before and after the award period, representing a wide variety of disciplines. Awardees that had completed their trainee period overwhelmingly remained active in translational research conducted within an academic setting. Early indications also suggest high rates of success with obtaining research funding subsequent to the KL2 award.

Conclusion

This project offers a model for how to collect and analyze common metrics related to the education and training function of the CTSA Consortium. Next steps call for expanding participation to other CTSA sites outside of the University of California system.     

Survey of the impact of National Institutes of Health clinical research curriculum awards (K30) between 1999 and 2004.

BACKGROUND: This report summarizes a survey conducted in 2004 by the Association of Clinical Research Training Program Directors' Evaluation Committee. The purpose of this survey was to determine the early capacity of the 59 National Institutes of Health (NIH) K30 programs (funded between 1999 and 2004) to produce clinical investigators trained in core skills required in clinical research. METHODS: In July 2004, a 37-item Web-based survey was distributed to institutions funded by the NIH K30 award mechanism. Frequencies and proportions were computed for each categorical response, and means were calculated for nominal responses using SPSS, version 11.5 (SPSS, Chicago, IL). Items 7 (funding year) and 8 (recruitment year) were cross-tabulated to ascertain the tempo at which programs were able to establish their enrolment processes. RESULTS: Forty-five of the 59 programs funded by the K30 award (76%) responded to this survey. The average number of active trainees in each program is 32. Women constitute 53% of active trainees, and 22% of them are underrepresented minorities. Ninety-six percent of active trainees have medical degrees. The average number of graduates over the 5-year funding period is 18. Of the graduates, 50% are women and 17% are underrepresented minorities. Fifty-six percent of them earned certificates, 44% earned master of science degrees, and 13% earned other degrees. Sixty-one percent of K30 program graduates have some extramural funding to support their research. The average number of publications per trainee for all trainees (active and graduate) is 2.3. CONCLUSION: The K30 program has been a catalyst at multiple US institutions for improving the pedagogy for clinical research training. It has successfully fulfilled the mandate set forth by the 1998 NIH Director's Panel on Clinical Research (Nathan Report).     

Instruction in the Responsible Conduct of Research: An Inventory of Programs and Materials within CTSAs

The National Institutes of Health (NIH) require instruction in the responsible conduct of research (RCR) as a component of any Clinical and Translational Science Award (CTSA). The Educational Materials Group of the NIH CTSA Consortium''s Clinical Research Ethics Key Function Committee (CRE‐KFC) conducted a survey of the 38 institutions that held CTSA funding as of January 2009 to determine how they satisfy RCR training requirements. An 8‐item questionnaire was sent by email to directors of the Clinical Research Ethics, the Educational and Career Development, and the Regulatory Knowledge cores. We received 78 completed surveys from 38 CTSAs (100%). We found that there is no unified approach to RCR training across CTSAs, many programs lack a coherent plan for RCR instruction, and most CTSAs have not developed unique instructional materials tailored to the needs of clinical and translational scientists. We recommend collaboration among CTSAs and across CTSA key function committees to address these weaknesses. We also requested that institutions send electronic copies of original RCR training materials to share among CTSAs via the CTSpedia website. Twenty institutions submitted at least one educational product. The CTSpedia now contains more than 90 RCR resources.     

Financial support for research training and career development in complementary and alternative medicine from the National Institutes of Health

Research careers are a relatively new reality for complementary and alternative medicine (CAM) practitioners (eg, chiropractors, naturopaths, doctors of oriental medicine, etc). Before the establishment in 1998 of the National Center for Complementary and Alternative Medicine (NCCAM) as part of the National Institutes of Health (NIH), there were few funding resources available for those interested in a CAM research career and fewer still feasible paths. Now, however, NCCAM provides a broad array of research training and career development awards for those seeking a long-term career in CAM research. These awards include predoctoral and postdoctoral fellowships, individual career development awards, and institutional training awards. The goal of this article is to provide information about current research training funding opportunities from NCCAM and NIH as a whole that are available to CAM practitioners in the context of the historical challenges of transitioning from a clinical career in CAM practice to a CAM research career.     

Assessing the Impact of the NIH CTSA Program on Institutionally Sponsored Clinical Trials

Objective

To assess the impact of the NIH CTSA program on patient enrollment in clinical trials sponsored/collaborated by CTSA consortium institutions.

Material and Methods

Using publicly available clinical trial data at ClinicalTrials.gov, we identify positive trend changes in the number of patients enrolled in clinical trials performed at CTSA consortium institutions over the years before and after their respective CTSA award dates. CTSA consortium institutions were matched with similar non‐CTSA institutions.

Results

As compared to matched non‐CTSA institutions CTSA consortium sites noted an increase in patient enrollment after the CTSA awards. In particular, we detected a change‐point, where a new enrollment trend emerged, 338 days after the CTSA award. No such trend was noted over the same period in the non‐CTSA institutions.

Conclusion

Our analysis provides evidence that the NIH CTSA funding program made a positive impact on patient enrollment.     

Artificial intelligence in clinical and translational science: Successes,challenges and opportunities

Artificial intelligence (AI) is transforming many domains, including finance, agriculture, defense, and biomedicine. In this paper, we focus on the role of AI in clinical and translational research (CTR), including preclinical research (T1), clinical research (T2), clinical implementation (T3), and public (or population) health (T4). Given the rapid evolution of AI in CTR, we present three complementary perspectives: (1) scoping literature review, (2) survey, and (3) analysis of federally funded projects. For each CTR phase, we addressed challenges, successes, failures, and opportunities for AI. We surveyed Clinical and Translational Science Award (CTSA) hubs regarding AI projects at their institutions. Nineteen of 63 CTSA hubs (30%) responded to the survey. The most common funding source (48.5%) was the federal government. The most common translational phase was T2 (clinical research, 40.2%). Clinicians were the intended users in 44.6% of projects and researchers in 32.3% of projects. The most common computational approaches were supervised machine learning (38.6%) and deep learning (34.2%). The number of projects steadily increased from 2012 to 2020. Finally, we analyzed 2604 AI projects at CTSA hubs using the National Institutes of Health Research Portfolio Online Reporting Tools (RePORTER) database for 2011–2019. We mapped available abstracts to medical subject headings and found that nervous system (16.3%) and mental disorders (16.2) were the most common topics addressed. From a computational perspective, big data (32.3%) and deep learning (30.0%) were most common. This work represents a snapshot in time of the role of AI in the CTSA program.     

Facilitating Emergency Care Research Networks: Integration into the Clinical Translational and Science Award (CTSA) Infrastructure

Emergency care research (ECR) does not fit neatly into the traditional National Institutes of Health (NIH) funding model, because emergency research involves undifferentiated disease presentations involving multiple disciplines and time-sensitive interventions. A task force of emergency care researchers and other stakeholders was convened to discuss the present and future state of clinical research networks. Integration of ECR with the Clinical Translational and Science Award (CTSA) program through a multidisciplinary emergency care research network (ECRN) would obviate the duplication of research efforts by disease-specific or institute-specific multicenter networks and reduce startup and maintenance costs. Strategies to enhance integration must include the training of emergency physician investigators in biostatistical and epidemiologic methods, as well as educating collaborative investigators in emergency care–related methodologies. Thus, an ECRN would be of great benefit to CTSA awardees and applicants and should be considered a priority.     

Evaluating Various Areas of Process Improvement in an Effort to Improve Clinical Research: Discussions from the 2012 Clinical Translational Science Award (CTSA) Clinical Research Management Workshop

Emphasis has been placed on assessing the efficiency of clinical and translational research as part of the National Institutes of Health (NIH) goal to “improve human health.” Improvements identified and implemented by individual organizations cannot address the research infrastructure needs of all clinical and translational research conducted. NIH''s National Center for Advancing Translational Sciences (NCATS) has brought together 61 Clinical and Translational Science Award (CTSA) sites creating a virtual national laboratory that reflects the diversity and breadth of academic medical centers to collectively improve clinical and translational science. The annual Clinical Research Management workshop is organized by the CTSA consortium with participation from CTSA awardees, NIH, and others with an interest in clinical research management. The primary objective of the workshop is to disseminate information that improves clinical research management although the specific objectives of each workshop evolve within the consortium. The fifth annual workshop entitled “Learning by doing; applying evidence‐based tools to re‐engineer clinical research management” took place in June 2012. The primary objective of the 2012 workshop was to utilize data to evaluate, modify, and improve clinical research management. This report provides a brief summary of the workshop proceedings and the major themes discussed among the participants.     

Emergency Medicine Public Health Research Funded by Federal Agencies: Progress and Priorities

The emergency department (ED) visit provides an opportunity to impact the health of the public throughout the entire spectrum of care, from prevention to treatment. As the federal government has a vested interest in funding research and providing programmatic opportunities that promote the health of the public, emergency medicine (EM) is prime to develop a research agenda to advance the field. EM researchers need to be aware of federal funding opportunities, which entails an understanding of the organizational structure of the federal agencies that fund medical research, and the rules and regulations governing applications for grants. Additionally, there are numerous funding streams outside of the National Institutes of Health (NIH; the primary federal health research agency). EM researchers should seek funding from agencies according to each agency's mission and aims. Finally, while funds from the Department of Health and Human Services (HHS) are an important source of support for EM research, we need to look beyond traditional sources and appeal to other agencies with a vested interest in promoting public health in EDs. EM requires a broad skill set from a multitude of medical disciplines, and conducting research in the field will require looking for funding opportunities in a variety of traditional and not so traditional places within and without the federal government. The following is the discussion of a moderated session at the 2009 Academic Emergency Medicine consensus conference that included panel discussants from the National Institutes of Mental Health, Drug Abuse, and Alcoholism and Alcohol Abuse and the Centers for Disease Control and Prevention (CDC). Further information is also provided to discuss those agencies and centers not represented.     

The Clinical Translation Gap in Child Health Exercise Research: A Call for Disruptive Innovation

In children, levels of play, physical activity, and fitness are key indicators of health and disease and closely tied to optimal growth and development. Cardiopulmonary exercise testing (CPET) provides clinicians with biomarkers of disease and effectiveness of therapy, and researchers with novel insights into fundamental biological mechanisms reflecting an integrated physiological response that is hidden when the child is at rest. Yet the growth of clinical trials utilizing CPET in pediatrics remains stunted despite the current emphasis on preventative medicine and the growing recognition that therapies used in children should be clinically tested in children. There exists a translational gap between basic discovery and clinical application in this essential component of child health. To address this gap, the NIH provided funding through the Clinical and Translational Science Award (CTSA) program to convene a panel of experts. This report summarizes our major findings and outlines next steps necessary to enhance child health exercise medicine translational research. We present specific plans to bolster data interoperability, improve child health CPET reference values, stimulate formal training in exercise medicine for child health care professionals, and outline innovative approaches through which exercise medicine can become more accessible and advance therapeutics across the broad spectrum of child health.     

Survey of mentoring programs for KL2 scholars

There is limited information on how academic institutions support effective mentoring practices for new investigators. A national semistructured telephone interview was conducted to assess current “state of the art” mentoring practices for KL2 scholars among the 46 institutions participating in the Clinical Translational Science Awards (CTSA) Consortium. Mentoring practices examined included: mentor selection, articulating and aligning expectations, assessing the mentoring relationship, and mentor training. Telephone interviews were conducted in winter/fall 2009, with 100% of the CTSAs funded (n=46) through 2009, participating in the survey. Primary findings include: fi ve programs selected mentors for K scholars, 14 programs used mentor contracts to define expectations, 16 programs reported formal mentor evaluation, 10 offered financial incentives to mentors, and 13 offered formal mentoring training. The interviews found considerable variation in mentoring practices for training new investigators among the 46 CTSAs. There was also limited consensus on“what works” and what are the core elements of “effective mentoring practices. Empirical research is needed to help research leaders decide on where and how to place resources related to mentoring     

Characteristics and Trends of Published Emergency Medicine Research

Objectives: Despite its importance in improving patient care, the state of published emergency medicine (EM) research is poorly understood. The countries of origin, methodological characteristics, sources of funding, and ongoing trends in this research are unknown. Knowledge of these characteristics has important policy, research, and clinical implications for academic EM.
Methods: The National Library of Medicine's PubMed database was searched for all articles published from 1996 to 2005 that originated from EM departments. The date and journal of publication, country of origin, study methodology, and, in the case of U.S. articles, acknowledgment of National Institutes of Health (NIH) grant support were noted. Journal impact factors of the publishing journal were assigned to each article. The aggregated data were then analyzed for country, journal of origin, and trend.
Results: Of the 14,605 articles originating from EM departments, the United States published 8,550 (58.54%), followed by the United Kingdom with 1,222 (8.37%) and Japan with 663 (4.54%). Significant publication growth was detected worldwide (116.6 articles per year; 95% confidence interval = 101.1 to 132.1; p < 0.0001) and in 17 of the top 20 EM research–producing countries. Among published U.S. studies, the NIH funded 388 (4.5%). Of all articles, 6,152 (41.8%) were published in dedicated EM journals.
Conclusions: Emergency medicine research output is increasing worldwide. The United States is the largest producer of EM research, only a small fraction of which is supported by the NIH. The majority of research published by emergency researchers is published in non-EM journals.     

Nurse Engagement and Contributions to the Clinical and Translational Science Awards Initiative

CTSAs are mandated to follow a multidisciplinary model. Requests for applications direct responsive applications to “integrate clinical and translational science across multiple departments, schools,” listing disciplines in addition to medicine such as engineering, nursing, and public health. This inventory of nurse engagement in CTSAs describes the extent of nursing''s CTSA engagement from the perspective of participating nurse scientists within individual CTSAs, including institutional/national contributions and best practices that foster a multidisciplinary model. Of the 50 CTSAs affiliated with a nursing school, 44 responded (88% response rate). Of the ten CTSAs not affiliated with a nursing school, four responded (40% response rate). Overall funding success rates of nurse applicants are: TL1 fellowships 81%, KL2 fellowships 54%, and nurse‐led pilots 58%. At most CTSAs nursing is contributing to the accomplishment of the CTSA mandate. The strongest categories of contribution are community engagement, implementation science, and training. Best practices to enhance multidisciplinary collaboration are: (1) inclusion of multiple disciplines on key committees who meet regularly to guide individual core and overall CTSA strategic planning and implementation; (2) required multidisciplinary co‐mentors (ideally from different schools within the CTSA) on training grants and as co‐investigators on pilot projects; and (3) documentation of multidisciplinary activity in annual reports.     

Current Status of Academic Emergency Medicine within Academic Medicine in the United States

ABSTRACT
Objective : To characterize the status of emergency medicine within U.S. academic medical centers.
Methods : All accredited emergency medicine residency programs and all four-year allopathic medical schools in the United States were identified. Institutions were defined as academic medical centers based upon NIH research grant funding. These institutions were ranked using five measures of academic stature: a survey of medical school deans, a survey of internal medicine residency directors, level of research funding, characteristics of the student body, and an unweighted composite variable reflecting overall academic stature. The relationship between institutional academic stature and an empiric scale of institutional affiliation with emergency medicine was assessed.
Results : Sixty-two institutions were designated academic medical centers. These medical schools captured 90% of all NIH grant monies awarded in fiscal year 1990. Twenty-six of 87 emergency medicine residency programs (30%) were closely affiliated with one of these medical schools. Within academic medical centers, the presence of a residency or an academic department of emergency medicine was inversely associated with the medical school deans' ranking (p < 0.005), research rank (p < 0.001), and composite academic rank (p < 0.0001).
Conclusion : The majority of emergency medicine residency programs (70%) are not closely affiliated with institutions receiving the bulk (90%) of NIH resources for research. Within the institutions receiving the majority of NIH funding, there is a quantitatively and statistically significant inverse association of institutional emergency medicine affiliation and institutional academic rank.