Alignment of Emergency Medicine Research Efforts with Clinical and Translational Science Awards

The Clinical and Translational Science Awards (CTSA) represent a major new funding pathway for health science investigators seeking National Institutes of Health (NIH) funds. This new pathway provides institutional-level support for clinical and translational research and is not tied to one organ system or disease process, fitting well with emergency medicine (EM) research needs. These awards open unique opportunities for advancing EM research. The CTSA mechanism provides institutional support from the NIH to promote both clinical and translational science. Of the 60 expected awards, 38 sites are currently funded. EM investigators can benefit the institutions applying for these awards and simultaneously gain from involvement. Some opportunities for participation provided by the CTSA include research training programs, joining multidisciplinary research teams, seed grant funding, and use of the CTSA-developed research infrastructure. Involvement of EM can benefit institutions by enhancing acute care research collaboration both within and among institutions. Emergency medicine researchers at institutions either planning to submit a CTSA application or with funded CTSA grants are encouraged to become actively involved in CTSA-related research programs.     

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.     

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.     

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.     

Social Network Analysis to Assess the Impact of the CTSA on Biomedical Research Grant Collaboration

Success of the Clinical Translational Science Award (CTSA) program implicitly demands team science efforts and well‐orchestrated collaboration across the translational silos (T1–T4). Networks have proven to be useful abstractions of research collaborations. Networks provide novel system‐level insights and exhibit marked changes in response to external interventions, making them potential evaluation tools that complement more traditional approaches. This study is part of our ongoing efforts to assess the impact of the CTSA on Biomedical Research Grant Collaboration (BRGC). Collaborative research grants are a complex undertaking and an outcome of sustained interaction among researchers. In this report, BRGC networks representing collaborations among CTSA‐affiliated investigators constructed from grants management system data at the University of Kentucky across a period of six years (2007–2012) corresponding to pre‐ and post‐CTSA are investigated. Overlapping community structure detection algorithms, in conjunction with surrogate testing, revealed the presence of intricate research communities rejecting random graphs as generative mechanisms. The deviation from randomness was especially pronounced post‐CTSA, reflecting an increasing trend in collaborations and team‐science efforts potentially as a result of CTSA. Intercommunity cross talk was especially pronounced post‐CTSA.     

NIH Grant Awards as a Metric of Clinical and Translational Research Training Effectiveness

The number of clinical research training programs has increased over the past 5–10 years, but few studies have quantitatively evaluated the effectiveness of these programs. The goal of this study was to evaluate the clinical and translational research training program at the University of Cincinnati by comparing the number of National Institutes of Health grants awarded to pediatric fellows who graduated from the MS degree program between 1995 and 2013 versus fellows who did not pursue an MS degree. Among 394 pediatric fellows, 16 of 81 (20%) MS alumni were awarded at least one NIH grant, as compared with 28 of 313 (9%) fellows who did not obtain an MS degree (p < 0.02). In multivariable analysis, MS alumni were more than three times as likely to have received at least one grant than were non‐MS fellows (OR = 3.5, 95% CI [1.7–7.2]; C‐statistic = 0.71) and MS alumni were more likely to obtain at least one K‐series (OR = 4.1, 95% CI [1.6–10.2]; C‐statistic = 0.74), M‐series (OR = 11.8, 95% CI [3.4–41.4]; C‐statistic = 0.81), or R‐series (OR = 10.1, 95% CI [2.4–42.8]; C‐statistic = 0.74) grant than were non‐MS fellows. These findings suggest that graduate training in clinical and translational research prepares graduates for the highly competitive field of clinical and translational research.     

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.     

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.     

Survey of Community Engagement in NIH‐Funded Research

Community engagement is an innovative and required component for Clinical and Translational Science Awards (CTSAs) funded by the National Institutes of Health (NIH). However, the extent of community engagement in NIH‐funded research has not been previously examined. This study assessed baseline prevalence of community engagement activities among NIH‐funded studies at a large Midwestern university with a CTSA. An online survey was e‐mailed to principal investigators of recent NIH‐funded studies (N = 480). Investigators were asked to identify what types of community engagement activities had occurred for each study. Responses were received for 40.4% (194/480) of studies. Overall, 42.6% reported any community engagement activities. More collaborative types of engagement (e.g., community advisory board) were less common than activities requiring less engagement (e.g., sharing study results with community members). Studies with more collaborative community engagement were less likely to be described as basic or preclinical research compared to all other studies. Given NIH''s inclusive call for community engagement in research, relatively few NIH‐funded studies reported community engagement activities, although this study used a broad definition of community and a wide range of types of engagement. These findings may be used to inform the goals of CTSA community engagement programs. Clin Trans Sci 2010; Volume *: 1–4     

The CTSA Consortium's Catalog of Assets for Translational and Clinical Health Research (CATCHR)

The 61 CTSA Consortium sites are home to valuable programs and infrastructure supporting translational science and all are charged with ensuring that such investments translate quickly to improved clinical care. Catalog of Assets for Translational and Clinical Health Research (CATCHR) is the Consortium''s effort to collect and make available information on programs and resources to maximize efficiency and facilitate collaborations. By capturing information on a broad range of assets supporting the entire clinical and translational research spectrum, CATCHR aims to provide the necessary infrastructure and processes to establish and maintain an open‐access, searchable database of consortium resources to support multisite clinical and translational research studies. Data are collected using rigorous, defined methods, with the resulting information made visible through an integrated, searchable Web‐based tool. Additional easy‐to‐use Web tools assist resource owners in validating and updating resource information over time. In this paper, we discuss the design and scope of the project, data collection methods, current results, and future plans for development and sustainability. With increasing pressure on research programs to avoid redundancy, CATCHR aims to make available information on programs and core facilities to maximize efficient use of resources.     

Community Engagement Strategies in the Original and Renewal Applications for CTSA Grant Funding

Purpose

The Clinical and Translational Science Award (CTSA) program has highlighted community engagement in research by requiring institutions to develop bidirectional relationships with communities to obtain funding. Little is known about how institutions have operationalized that requirement. This study aimed to describe the strategies proposed by the first institutions to receive CTSA funding and to undergo the CTSA renewal process.

Methods

The authors conducted a qualitative document analysis of the community engagement section of 12 original and 10 renewal grant applications of the 12 institutions awarded CTSA funding in 2006 and renewed in 2010.

Results

Institutions employed ‐ and research engagement strategies. Capacity‐building strategies included education, pilot grants, connecting potential partners, and community research centers. Research engagement strategies ranged from those that allowed for very little input from communities, such as announcements, to those that allowed for a high amount of input from communities, such as community‐researcher teams.

Conclusion

CTSA funding has supported capacity‐building for institutions and communities to partner. Engagement strategies employed by the institutions are largely known from prior community‐engaged research. Based on the grants from these institutions, the CTSA funding has largely enabled institutions to develop capacity to engage.     

Models of Interinstitutional Partnerships between Research Intensive Universities and Minority Serving Institutions (MSI) across the Clinical Translational Science Award (CTSA) Consortium

Health disparities are an immense challenge to American society. Clinical and Translational Science Awards (CTSAs) housed within the National Center for Advancing Translational Science (NCATS) are designed to accelerate the translation of experimental findings into clinically meaningful practices and bring new therapies to the doorsteps of all patients. Research Centers at Minority Institutions (RCMI) program at the National Institute on Minority Health and Health Disparities (NIMHD) are designed to build capacity for biomedical research and training at minority serving institutions. The CTSA created a mechanism fostering formal collaborations between research intensive universities and minority serving institutions (MSI) supported by the RCMI program. These consortium‐level collaborations activate unique translational research approaches to reduce health disparities with credence to each academic institutions history and unique characteristics. Five formal partnerships between research intensive universities and MSI have formed as a result of the CTSA and RCMI programs. These partnerships present a multifocal approach; shifting cultural change and consciousness toward addressing health disparities, and training the next generation of minority scientists. This collaborative model is based on the respective strengths and contributions of the partnering institutions, allowing bidirectional interchange and leveraging NIH and institutional investments providing measurable benchmarks toward the elimination of health disparities.     

Defining the Components of the Research Pipeline

The National Institutes of Health (NIH) has proposed that research moves from “bench to bedside” through a Pipeline consisting of distinct research categories bridged by bidirectional translation. The original NIH Pipeline has now been expanded to include practice‐ and community‐based research. We developed operational definitions for the elements along the expanded NIH Pipeline. The proposed definitions were pilot‐tested and refined using the Computer Retrieval of Information on Scientific Projects (CRISP) and the Secure Internet‐Linked Web Technologies (SILK) database containing funding information for individual NIH awards. Using our definitions, two reviewers independently agreed on the categorization of 94% of 866 National Heart, Lung, and Blood Institute (NHLBI)‐funded projects, and 99% of projects could be placed into a single research category.     

Faculty Perceptions of How Community‐Engaged Research Is Valued in Tenure,Promotion, and Retention Decisions

Purpose

We assessed the perceptions of community core faculty in academic medical center institutions that received Clinical and Translational Science Awards (CTSA) about how these institutions consider community‐engaged scholarship (CES) when tenure, promotion, and retention decisions are made.

Method

An assessment tool was adapted to create an 18‐item survey that was sent during November and December 2011 via the Internet to the 369 members of the community‐engagement core mailing list of the CTSA.

Results

Fifty‐nine responses were received which represented 37 of the possible 60 different funded institutions. The mean score was 48.14 (SD = 11.18); range of 23–74; and Cronbach''s alpha was .91 About half reported that support for CES and its inclusion in the academic decision process increased since the institution was awarded a CTSA. Open‐ended responses indicated some confusion with terminology although a definition of CES had been provided in the instrument instructions.

Conclusion

Respondents overall agreed there was moderate support for CES in tenure, promotion, and retention decisions which may have been influenced by the CTSA application requirements. This survey could be used to identify if there are differences in institutional and departments and measure changes over time.     

Evaluation Guidelines for the Clinical and Translational Science Awards (CTSAs)

The National Center for Advancing Translational Sciences (NCATS), a part of the National Institutes of Health, currently funds the Clinical and Translational Science Awards (CTSAs), a national consortium of 61 medical research institutions in 30 states and the District of Columbia. The program seeks to transform the way biomedical research is conducted, speed the translation of laboratory discoveries into treatments for patients, engage communities in clinical research efforts, and train a new generation of clinical and translational researchers. An endeavor as ambitious and complex as the CTSA program requires high‐quality evaluations in order to show that the program is well implemented, efficiently managed, and demonstrably effective. In this paper, the Evaluation Key Function Committee of the CTSA Consortium presents an overall framework for evaluating the CTSA program and offers policies to guide the evaluation work. The guidelines set forth are designed to serve as a tool for education within the CTSA community by illuminating key issues and practices that should be considered during evaluation planning, implementation, and utilization. Additionally, these guidelines can provide a basis for ongoing discussions about how the principles articulated in this paper can most effectively be translated into operational reality.     

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.     

Promotion and Tenure for Community‐Engaged Research: An Examination of Promotion and Tenure Support for Community‐Engaged Research at Three Universities Collaborating through a Clinical and Translational Science Award

Introduction

Community‐engaged health research, an approach to research which includes the participation of communities, promotes the translation of research to address and improve social determinants of health. As a way to encourage community‐engaged research, the National Institutes of Health required applicants to the Clinical and Translational Science Award (CTSA) to include a community engagement component. Although grant‐funding may support an increase in community‐engaged research, faculties also respond to the rewards and demands of university promotion and tenure standards. This paper measures faculty perception of how three institutions funded by a CTSA support community‐engaged research in the promotion and tenure process.

Methods

At three institutions funded by a CTSA, tenure track and nontenure track faculty responded to a survey regarding perceptions of how promotion and tenure committees value community‐engaged research.

Results

Faculty view support for community‐engaged research with some reserve. Only 36% agree that community‐engaged research is valued in the promotion and tenure process.

Discussion

Encouraging community‐engaged scholarship requires changing the culture and values behind promotion and tenure decisions. Institutions will increase community‐engaged research and more faculty will adopt its principles, when it is rewarded by promotion and tenure committees.     

Designing a CTSA‐Based Social Network Intervention to Foster Cross‐Disciplinary Team Science

This paper explores the application of network intervention strategies to the problem of assembling cross‐disciplinary scientific teams in academic institutions. In a project supported by the University of Florida (UF) Clinical and Translational Science Institute, we used VIVO, a semantic‐web research networking system, to extract the social network of scientific collaborations on publications and awarded grants across all UF colleges and departments. Drawing on the notion of network interventions, we designed an alteration program to add specific edges to the collaboration network, that is, to create specific collaborations between previously unconnected investigators. The missing collaborative links were identified by a number of network criteria to enhance desirable structural properties of individual positions or the network as a whole. We subsequently implemented an online survey (N = 103) that introduced the potential collaborators to each other through their VIVO profiles, and investigated their attitudes toward starting a project together. We discuss the design of the intervention program, the network criteria adopted, and preliminary survey results. The results provide insight into the feasibility of intervention programs on scientific collaboration networks, as well as suggestions on the implementation of such programs to assemble cross‐disciplinary scientific teams in CTSA institutions.     

Translational research: moving discovery to practice

In the first week of October, I announced the launch of a national consortium that will transform how clinical and translational research is conducted; ultimately enabling researchers to provide new treatments more efficiently and quickly to patients. This new consortium, funded through Clinical and Translational Science Awards (CTSAs), begins with 12 academic health centers (AHCs) located throughout the nation. An additional 52 AHCs are receiving planning grants to help them prepare to apply for a CTSA.     

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.