Clinical And Translational Science Award Consortium Research Articles

Scope, Influence, and Interdisciplinary Collaboration: The Publication Portfolio of the NIH Clinical and Translational Science Awards (CTSA) Program From 2006 Through 2017.

The Clinical and Translational Science Awards (CTSA) program sponsors an array of innovative, collaborative research. This study uses complementary bibliometric approaches to assess the scope, influence, and interdisciplinary collaboration of publications supported by single CTSA hubs and those supported by multiple hubs. Authors identified articles acknowledging CTSA support and assessed the disciplinary scope of research areas represented in that publication portfolio, their citation influence, interdisciplinary overlap among research categories, and characteristics of publications supported by multihub collaborations. Since 2006, CTSA hubs supported 69,436 articles published in 4,927 journals and 189 research areas. The portfolio is well distributed across diverse research areas with above-average citation influence. Most supported publications involved clinical/health sciences, for example, neurology and pediatrics; life sciences, for example, neuroscience and immunology; or a combination of the two. Publications supported by multihub collaborations had distinct content emphasis, stronger citation influence, and greater interdisciplinary overlap. This study characterizes the CTSA consortium's contributions to clinical and translational science, identifies content areas of strength, and provides evidence for the success of multihub collaborations. These methods lay the foundation for future investigation of the best policies and priorities for fostering translational science and allow hubs to understand their progress benchmarked against the larger consortium.

3355 The CTSA Institutional website: A higher purpose - Researcher use of institutional Clinical and Translational Science Award (CTSA) website content to assess or promote NCATS CTSA Program Goals.

3355 The CTSA Institutional website: A higher purpose - Researcher use of institutional Clinical and Translational Science Award (CTSA) website content to assess or promote NCATS CTSA Program Goals.

2563 National dissemination of the accrual to clinical trials (ACT) network across the Clinical and Translational Science Award (CTSA) Consortium

OBJECTIVES/SPECIFIC AIMS: The ACT Network was developed by 46 members of the CTSA Program hubs in collaboration with NCATS to help investigators explore and validate feasibility of clinical studies in real-time using linked electronic health record data for cohort discovery. ACT is being disseminated nationally across the CTSA consortium. METHODS/STUDY POPULATION: Diffusion of Innovation Theory and Lean Start-Up principles inform dissemination strategies. Core materials were developed nationally and are being tailored to meet local CTSA dissemination norms. An advisory board, with expertise in communications, journalism, customer channel management, pharmaceutical commercialization and health IT entrepreneurship, is providing strategic advice to develop and refine dissemination strategies. Evaluation of dissemination methods will include network usage and web analytics for the ACT Network’s interactive digital content and log-in portal, and surveys-interviews of ACT users using the RE-AIM implementation framework. RESULTS/ANTICIPATED RESULTS: Formative research identified ACT’s primary value proposition for clinical researchers: “Explore patient populations in depth, in real time, from your desktop;” “Confirm study feasibility by iteratively testing and refining inclusion and exclusion criteria;” “Demonstrate feasibility in funding proposals and IRB submissions;” and “Identify collaborating sites for multi-site studies by searching for patients across the CTSA network.” Early dissemination metrics, including number-type of registered users, queries performed, and web analytics, will be presented. DISCUSSION/SIGNIFICANCE OF IMPACT: Researchers nationwide face common barriers in accruing enough participants for clinical trials. The inability to identify the right number and type of people to participate often makes clinical trials slow and costly. Better cohort discovery at the protocol development phase is a necessary requirement. By end of 2018, the ACT Network will reach 60% of the CTSA consortium providing a new tool for investigators to improve the design and execution of clinical trials.

2520

OBJECTIVES/SPECIFIC AIMS: Across the Clinical and Translational Science Award (CTSA) Consortium, participant recruitment into clinical trials is essential to advance science. Without proper participant recruitment, clinical trials do not result in gains in scientific knowledge, wastes time, funds, and other resources (Mahon et al., 2015). METHODS/STUDY POPULATION: Participant recruitment programs across the consortium are inconsistent in staffing, program services, and program goals. The participant recruitment program at the University of Michigan’s (U-M) Michigan Institute for Clinical & Health Research (MICHR) provides expertise, tools, and resources to facilitate participant recruitment in clinical and health research studies. RESULTS/ANTICIPATED RESULTS: We will explain our program infrastructure, staffing, services, and discuss how we maintain an engaged registry with over 27,000 participants interested in research studies at U-M. DISCUSSION/SIGNIFICANCE OF IMPACT: Proper recruitment into clinical trials results in findings that are relevant for genetic, cultural, linguistic, racial/ethnic, gender, and age differences (Cottler et al., 2013). We hope to share our best practices that aid in the development and success of participant recruitment across the CTSA Consortium.

Emergency Medicine Resources Within the Clinical Translational Science Institutes: A Cross-sectional Study.

The Clinical and Translational Science Award (CTSA) program aims to strengthen and support translational research by accelerating the process of translating laboratory discoveries into treatments for patients, training a new generation of clinical and translational researchers, and engaging communities in clinical research efforts. Yet, little is known about how emergency care researchers have interacted with and utilized the resources of academic institutions with CTSAs. The purpose of this survey was to describe how emergency care researchers use local CTSA resources, to ascertain what proportion of CTSA consortium members have active emergency care research (ECR) programs, and to solicit participation in a national CTSA-associated emergency care translational research network. This study was a survey of all emergency departments affiliated with a CTSA. Of the 65 CTSA consortium members, three had no ECR program and we obtained responses from 46 of the remaining 62 (74% response rate). The interactions with and resources used by emergency care researchers varied widely. Methodology and biostatistics support was most frequently accessed (77%), followed closely by education and training programs (60%). Several ECR programs (76%) had submitted for funding through CTSAs, with 71% receiving awards. Most CTSA consortium members had an active ECR infrastructure: 21 (46%) had 24/7 availability to recruit and screen for research, and 21 (46%) had less than 24/7 research recruitment. A number of emergency care research programs participated in National Institutes of Health research networks with the Neurological Emergencies Treatment Trials network most highly represented with 23 (59%) sites. Most ECR programs (96%) were interested in participating in a CTSA-based emergency care translational research network. Despite little initial involvement in development of the CTSA program, there has been moderate interaction between CTSAs and emergency care. There is considerable interest in participating in a CTSA consortium-based emergency care translational research network.

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

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. 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. 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. 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.

CTSA Consortium Consensus Scientific Review Committee (SRC) Working Group Report on the SRC Processes.

Human research projects must have a scientifically valid study design, analytic plan, and be operationally feasible in order to be successfully completed and thus to have translational impact. To ensure this, institutions that conduct clinical research should have a scientific review process prior to submission to the Institutional Review Committee (IRB). This paper reports the Clinical and Translational Science Award (CTSA) Consortium Scientific Review Committee (SRC) Consensus Working Group's proposed framework for a SRC process. Recommendations are provided for institutional support and roles of CTSAs, multisite research, criteria for selection of protocols that should be reviewed, roles of committee members, application process, and committee process. Additionally, to support the SCR process effectively, and to ensure efficiency, the Working Group recommends information technology infrastructures and evaluation metrics to determine outcomes are provided.

Dismantling and rebuilding bureaucracies: reinventing wheels on rebranded hubs.

Dismantling and rebuilding bureaucracies: reinventing wheels on rebranded hubs.

Towards a unified taxonomy of health indicators: academic health centers and communities working together to improve population health.

The Clinical and Translational Science Awards (CTSA) program represents a significant public investment. To realize its major goal of improving the public’s health and reducing health disparities, the CTSA Consortium’s Community Engagement Key Function Committee has undertaken the challenge of developing a taxonomy of community health indicators. The objective is to initiate a unified approach for monitoring progress in improving population health outcomes. Such outcomes include, importantly, the interests and priorities of community stakeholders, plus the multiple, overlapping interests of universities and of the public health and health care professions involved in the development and use of local health care indicators.The emerging taxonomy of community health indicators that the authors propose supports alignment of CTSA activities and facilitates comparative effectiveness research across CTSAs, thereby improving the health of communities and reducing health disparities. The proposed taxonomy starts at the broadest level, determinants of health; subsequently moves to more finite categories of community health indicators; and, finally, addresses specific quantifiable measures. To illustrate the taxonomy’s application, the authors have synthesized 21 health indicator projects from the literature and categorized them into international, national, or local/special jurisdictions. They furthered categorized the projects within the taxonomy by ranking indicators with the greatest representation among projects and by ranking the frequency of specific measures. They intend for the taxonomy to provide common metrics for measuring changes to population health and, thus, extend the utility of the CTSA Community Engagement Logic Model. The input of community partners will ultimately improve population health.

Proposed regulations for research with biospecimens: Responses from stakeholders at CTSA consortium institutions

Secondary research with biospecimens acquired through clinical care and through research is often conducted without the informed consent of individuals from whom the specimens were acquired. While such uses are consistent with the current federal regulations, surveys of the general public suggest that many individuals would prefer more information and choice regarding research use of biospecimens. The federal government issued an Advance Notice of Proposed Rulemaking (ANPRM) in 2011 that proposed a number of potential changes in the regulations governing human subjects. These proposed regulations are particularly pertinent to institutions committed to research involving human subjects-including institutions in the NIH-funded Clinical and Translational Science Awards (CTSA) consortium. In this study, we reviewed public responses by CTSA-funded institutions and CTSA-affiliated organizations and groups regarding the proposed changes in the ANPRM with respect to research with biospecimens. Our results indicate that the majority of responses to the ANPRM from CTSA institutions were not supportive of the proposed changes. While many responses acknowledge a need to change current research practices regarding biospecimens, the proposed changes in the ANPRM received only limited support from this subgroup of academic research institutions.

Library-based clinical and translational research support

There has been a shift in the workflow at academic biomedical research and clinical care centers to promote more efficient clinical and community implementation of bench discoveries. Strong financial support for this effort is provided by the Clinical and Translational Science Awards (CTSAs) from the National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH), awarded to about sixty biomedical research institutions constituting the CTSA Consortium [1]. CTSAs offer an opportunity to speed the translation of bench discoveries to improved human health by transforming the

Common Metrics to Assess the Efficiency of Clinical Research

The Clinical and Translational Science Award (CTSA) program was designed by the National Institutes of Health (NIH) to develop processes and infrastructure for clinical and translational research throughout the United States. The CTSA initiative now funds 61 institutions. In 2012, the National Center for Advancing Translational Sciences, which administers the CTSA Program, charged the Evaluation Key Function Committee of the CTSA Consortium to develop common metrics to assess the efficiency of clinical research processes and outcomes. At this writing, the committee has identified 15 metrics in six categories. It has also developed a standardized protocol to define, pilot test, refine, and implement the metrics. The ultimate goal is to learn critical lessons about how to evaluate the processes and outcomes of clinical research within the CTSAs and beyond. This article describes the work involved in developing and applying common metrics and benchmarks of evaluation.

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.

The Sharing Partnership for Innovative Research in Translation (SPIRiT) Consortium: A Model for Collaboration across CTSA Sites

In 2006, the National Institutes of Health (NIH) created the Clinical and Translational Science Award (CTSA) program to “transform the local, regional and national environment for clinical and translational science, thereby increasing the efficiency and speed of clinical and translational research.”1 Since then, 61 CTSA-funded sites have reengineered their local research enterprises to develop cadres of highly trained translational scientists and provide them with a robust array of research resources. Now under the direction of the National Center for Advancing Translational Science (NCATS), the maturing CTSA program is poised to enter its second stage of development to provide “institutions with greater flexibility and more opportunities to build on institutional strengths.”2 This approach is supported by a new CTSA Funding Opportunity Announcement (FOA) that will enable CTSA sites to develop programs to address the specific needs of their investigators and local communities. As a result, institutional CTSA programs will likely evolve from a model that provides a set of common research resources locally to unique programs with a mix of core infrastructure (e.g., training, informatics) that is supplemented by institution-specific resources (e.g., drug discovery, comparative effectiveness research, and research implementation and dissemination cores). Leveraging complementary institutional capabilities through closer collaborations between CTSA sites is the logical next step for the National CTSA Consortium. During the formative years of the CTSA program, several sites forged collaborations by creating regional consortia based on geographic proximity to enable sharing of local resources and meetings of trainees.3 For example, the Chicago Consortium for Community Engagement represents a collaboration among the three Chicago CTSAs to advance coordinated and synergistic approaches to developing community-partnered research, disseminating research results, and providing training in community engagement methods to collaborators in academic and community-based organizations. The Ohio Consortium of three CTSA sites implemented a statewide central institutional review board model. In Texas, several institutions meet to exchange best practices. However, collaborative efforts that are constrained by geographic location may limit the benefits that can be derived from linking scientists, institutions, resources, and innovative tools across an array of institutions with complementary capabilities. Accordingly, six geographically dispersed CTSA sites (Johns Hopkins University, University of Chicago, University of Pennsylvania, University of Pittsburgh, Washington University at St. Louis, Yale University) formed a “virtual CTSA consortium” based on a shared vision for data sharing and prior collaborations focused on informatics initiatives. The initial goals of the six-site Sharing Partnership for Innovative Research in Translation (SPIRiT) Consortium were 1) to develop a data sharing infrastructure for biospecimen-based research and de-identified clinical research data, and 2) to establish inter-institutional collaborations related to pilot studies, regulatory support, core laboratory facilities, and education and career development. Over the past two years, the SPIRiT Consortium embarked on several initiatives to achieve these goals, including the deployment of an informatics software and regulatory infrastructure to enable discovery and sharing of banked pathology specimens, development of an inter-institutional pilot study program to link investigators, and validation of a novel technology to improve the diagnosis of malignant melanoma. These programs are described below.

Dissemination and implementation of comparative effectiveness evidence: key informant interviews with Clinical and Translational Science Award institutions

To identify ongoing practices and opportunities for improving national comparative effectiveness research (CER) translation through dissemination and implementation (D&I) via NIH-funded Clinical and Translational Science Award (CTSA) institutions. Key informant interviews were conducted with 18 CTSA grantees sampled to represent a range of D&I efforts. The institutional representatives endorsed fostering CER translation nationally via the CTSA Consortium. However, five themes emerged from the interviews as barriers to CER D&I: lack of institutional awareness, insufficient capacity, lack of established D&I methods, confusion among stakeholders about what CER actually is and limited funding opportunities. Interviewees offered two key recommendations to improve CER translation: development of a centralized clearing house to facilitate the diffusion of CER D&I resources and methods across CTSA institutions; and formalization of the national CTSA network to leverage existing community engagement relationships and resources for the purpose of adapting and disseminating robust CER evidence locally with providers, patients and healthcare systems.

The Utah Center for Clinical and Translational Science: Transformation through Collaboration

The Intermountain West encompasses a 400,000 square mile area that includes the states of Utah, Idaho, Wyoming, and Montana. Within the region the University of Utah Health Sciences Center (UUHSC) is the only academic health center and Intermountain Healthcare (Intermountain), a not-for profit corporation, is the largest healthcare provider. The UUHSC and Intermountain are competitors for clinical market share in most service lines. Both UUHSC and Intermountain have significant research enterprises and each has different strengths. The University of Utah developed the first Biomedical Informatics Department in the nation, is internationally recognized for research in human genetics, and has robust programs in molecular medicine and other laboratory-based sciences. Intermountain is internationally recognized for health services research and programs in quality improvement. The impetus for collaboration in the research enterprise was however, limited before the national initiative to establish a consortium of academic health centers supported through the National Institutes of Health (NIH) clinical and translational science awards (CTSA). Here we describe the transformation of the clinical research environment in the Intermountain West as a result of the collaborative relationships developed between UUHSC and Intermountain following the establishment of the Utah Center for Clinical and Translational Science (CCTS) through the CTSA consortium. Founded in 1905, the University of Utah School of Medicine, located in Salt Lake City, houses 16 clinical and 6 basic science departments. In collaboration with UUHSC, the faculty and staff of the University of Utah educate and train healthcare professionals, conduct research, and provide medical care for adults and children in Utah and the surrounding Intermountain states. Intermountain Healthcare (Intermountain), founded in 1975, is a not-for-profit, integrated healthcare delivery system based in Salt Lake City, UT. Intermountain is the largest healthcare provider in the Intermountain West, providing healthcare services in southeastern Idaho plus the entire state of Utah and operating 23 inpatient facilities including one tertiary children’s hospital, Primary Children’s Medical Center [PCMC] in Salt Lake City, UT. Over 500 multi-specialty physicians are employed through the Intermountain Medical Group and hundreds of other affiliated providers practice in Intermountain hospitals and clinics. Within the region, competition related to clinical market share decreased the ability of institutions to collaborate. Exceptions included 1) the delivery of inpatient pediatric care at PCMC which is owned and operated by Intermountain and staffed by both UUHSC and Intermountain physicians and 2) the training of physicians to serve several western states in both urban and rural locations which resulted in a well-developed Affiliation Agreement defining teaching programs operated in several Intermountain hospitals for UUHSC trainees. Intermountain and UUHSC operate integrated residency and fellowship programs in medicine, obstetrics and gynecology, pediatrics, radiation therapy, and surgery. In contrast, the collaboration in the research enterprise for the past three decades had been limited to the efforts of individual investigators and there were no institutional policies or infrastructure to systematically support the research efforts across institutions or to share resources. The national competition to join the CTSA consortium provided an opportunity to re-evaluate the research relationship and to and develop and support research collaboration between both institutions. UUHSC and Intermountain joined forces in order to apply for a CTSA and to represent the Intermountain West in the consortium. The Utah Center for Clinical and Translational Science (CCTS) became part of the national CTSA consortium in 2008. Linkages created through the CCTS across both organizations have served to create productive and trusting work relationships, allowing us to provide a shared research infrastructure that takes advantage of our innovative systems and shared intellectual capital of personnel. These linkages have increased collaboration and resulted in significant benefits for both instituions.

CTSA-Enhanced Innovative Device Development

The key objective of the NIH Clinical and Translational Science Award (CTSA) is to more effectively translate basic science discoveries into new human therapies, diagnostics, and practices. Given the societal impression that we are in an unprecedented time of scientific and technologic acceleration in biomedical research, it can be disheartening to learn that it takes up to 15 years for discoveries to translate into treatments and that a large majority of medical research studies never reach the clinical trials or become widely available to patients (1). As part of the CTSA consortium, the University of New Mexico Clinical and Translational Science Center (CTSC) is a catalyst for more rapid translation within the pipeline of therapeutic development by encouraging innovation and high-risk projects, facilitating productive collaborations, assisting with study design, supporting clinical trials, and providing new mechanisms to more rapidly and effectively address regulatory requirements. CTSAs at comparatively smaller universities such as ours immediately transform the research landscape of their institutions, since support mechanisms for clinical and translational research would not otherwise exist. Now in its third year, the UNM CTSC was able to assist in the development of a point-of-care biosensor, which recently received an R&D Magazine Top 100 Technologies Award (2). Our biosensor project demonstrates the efficacy of the CTSA model in translating basic science conducted at universities into devices that will dramatically improve clinical practices.

Preliminary Competencies for Comparative Effectiveness Research

The Clinical and Translational Science Award (CTSA) Workgroup for Comparative Effectiveness Research (CER) Education, Training, and Workforce Development identified a need to delineate the competencies that practitioners and users of CER for patient-centered outcomes research, should acquire. With input from CTSA representatives and collaborators, we began by describing the workforce. We recognize the workforce that conducts CER and the end users who use CER to improve the health of individuals and communities. We generated a preliminary set of competencies and solicited feedback from the CER representatives at each member site of the CTSA consortium. We distinguished applied competencies (i.e., skills needed by individuals who conduct CER) from foundational competencies that are needed by the entire CER workforce, including end users of CER. Key competency categories of relevance to both practitioners and users of CER were: (1) asking relevant research questions; (2) recognizing or designing ideal CER studies; (3) executing or using CER studies; (4) using appropriate statistical analyses for CER; and (5) communicating and disseminating CER study results to improve health. Although CER is particularly broad concept, we anticipate that these preliminary, relatively generic competencies will be used in tailoring curricula to individual learners from a variety of programmatic perspectives.

Working with the CTSA Consortium: What We Bring to the Table

In 2006, the National Institutes of Health (NIH) initiated the Clinical and Translational Science Awards (CTSA) program to establish premier academic sites designed to enhance the efficiency and effectiveness of translational research at the local, regional, and national levels. In February 2010, the NIH sponsored a national CTSA forum on "Promoting Efficient and Effective Collaborations Among Academia, Government, and Industry." This forum brought together a broad set of stakeholders who were charged with developing a path for promoting such partnerships. One theme, discussed in this meeting report, focused on opportunities and approaches to leverage CTSA institutions as a consortium in fostering public-private partnerships.

Training and Career Development for Comparative Effectiveness Research Workforce Development: CTSA Consortium Strategic Goal Committee on Comparative Effectiveness Research Workgroup on Workforce Development

As comparative effectiveness research (CER) increasingly becomes a national priority, there are increased needs for training and workforce development in this area. Particularly important CER competencies include clinical epidemiology, biomedical informatics, economic analyses, systematic reviews, clinical practice guideline development, use of large databases and electronic health records for research, practice-based research, implementation and dissemination, health services research, and decision analysis. Institutions funded by Clinical and Translational Science Awards (CTSAs) should be one of the central stakeholders in providing training and career development in CER. Survey results regarding the current CER capacity and needs of CTSAs are presented, and recommendations are provided. Volume 5: 258-262.