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.     

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.     

Clinical and Translational Research Capacity Building Needs in Minority Medical and Health Science Hispanic Institutions

A preliminary needs assessment was conducted among faculty and students of three minority medical and health science institutions comprising the Puerto Rico Clinical and Translational Research Consortium (PRCTRC). The Web‐based survey was focused on evaluating the training interests in the clinical and translational research core areas and competencies developed by the National Institutes of Health‐Clinical and Translational Sciences Award. The survey was the result of a team effort of three PRCTRC key function''s leaderships: Multidisciplinary Training and Career Development, Tracking and Evaluation and Community Research and Engagement. The questionnaire included 45 items distributed across five content areas including demographics, research training needs, training activities coordination and knowledge about the services offered by the PRCTRC. Analysis of research needs includes a sample distribution according to professor, assistant/associate professor and graduate students. The thematic area with highest response rate among the three groups was: “Identify major clinical/public health problems and relevant translational research questions,” with the competency “Identify basic and preclinical studies that are potential testable clinical research hypothesis.” These preliminary results will guide the training and professional development of the new generation of clinical and translational researchers needed to eliminate health disparities.     

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.     

Using research metrics to improve timelines: proceedings from the 2nd Annual CTSA clinical research management workshop

The Clinical and Translational Science Award (CTSA) Consortium Workshop was conceived as a venue to foster communication among academic medical centers (AMCs) in the development of methods to improve clinical research management. The consortium, comprised of 46 awardee sites as of 2009, many with multiple AMCs, is expected to expand to 60 sites when fully implemented. At the 2nd Annual CTSA Clinical Research Management Workshop held on June 22nd and 23rd , 2009, on the National Institutes of Health (NIH) campus, consortium members and potential CTSA sites gathered with stakeholders from private industry, the NIH, the Food and Drug Administration, and private research organizations, to formulate a plan to address challenges in clinical research management. Specific aims included improving protocol processing and sharing process improvement initiatives in the expectation that best practices will be implemented and improvements will be measured and reported. The findings presented at this workshop indicated significant variance in Institutional Review Board approval of protocols and contract execution by AMC and CTSA sites. Most represented marked delays compared to non-AMC sites and that, as a likely consequence, AMCs were later to enroll patients and/or meet enrollment targets compared to dedicated or professional sites.     

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.     

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.     

From Genes to Community: Exploring Translational Science in Adolescent Health Research: Proceedings from a Research Symposium

Addressing complex adolescent health problems such as youth violence and teen pregnancy requires innovative strategies to promote protective social environments, increase healthier behaviors, and reduce the impact of health risk behaviors into adulthood. Multilevel, interdisciplinary, and translational approaches are needed to address these challenges in adolescent health. In May 2012, a group of adolescent health researchers participated in a 1‐day research symposium titled “From Genes to Community: Exploring Translational Science in Adolescent Health Research,” sponsored by the Clinical and Translational Science Institute (CTSI) of the University of Pittsburgh and the Division of Adolescent Medicine, Children''s Hospital of Pittsburgh of the University of Pittsburgh Medical Center. The research symposium offered opportunities for adolescent health researchers to share examples of translational research as well as to identify potential collaborations to promote translational research. This and subsequent issues of Clinical and Translational Science will include papers from this symposium. The studies and reviews presented range from how basic biobehavioral sciences such as functional neuroimaging and decision science can be made relevant for intervention development as well as improving strategies for community‐partnered knowledge transfer of cutting‐edge research findings to promote adolescent health and well‐being. Clin Trans Sci 2012; Volume 5: 480–481     

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.     

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.     

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.     

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 Critical Need for Academic Health Centers to Assess the Training,Support, and Career Development Requirements of Clinical Research Coordinators: Recommendations from the Clinical and Translational Science Award Research Coordinator Taskforce

Clinical Research Coordinators (CRCs) are a vital component of the clinical research enterprise providing a pivotal role in human subject protection through the numerous activities and responsibilities assigned to them. In 2006, the National Institutes of Health’s National Center for Research resources (NCRR) implemented the Clinical and Translational Science Awards program (CTSA) to advance biomedical research. As a part of this endeavor, many workgroups were formed among the Consortium to support translational research. The Research Coordinator Taskforce was created as part of the Regulatory Knowledge group of the Clinical Research Innovation Key Function Committee, and focuses on enhancing CTSA capabilities to provide support and training for CRCs. In the spring of 2008, this taskforce conducted two surveys of the then 24 CTSA Consortium members to better understand the current expectations and responsibilities of research coordinators in addition to the mechanism for providing education, training, and support in order for CRCs to successfully meet the study responsibilities placed upon them. The results of these surveys are summarized in this article and provide context to the recommendations of the Research Coordinator Taskforce for institutional considerations, approaches, and best practices for providing education, training, and support the expanding role of CRCs in fulfilling their responsibilities delegated to them by investigators. Clin Trans Sci 2012; Volume 5: 470–475     

A National Strategy to Develop Pragmatic Clinical Trials Infrastructure

An important challenge in comparative effectiveness research is the lack of infrastructure to support pragmatic clinical trials, which compare interventions in usual practice settings and subjects. These trials present challenges that differ from those of classical efficacy trials, which are conducted under ideal circumstances, in patients selected for their suitability, and with highly controlled protocols. In 2012, we launched a 1‐year learning network to identify high‐priority pragmatic clinical trials and to deploy research infrastructure through the NIH Clinical and Translational Science Awards Consortium that could be used to launch and sustain them. The network and infrastructure were initiated as a learning ground and shared resource for investigators and communities interested in developing pragmatic clinical trials. We followed a three‐stage process of developing the network, prioritizing proposed trials, and implementing learning exercises that culminated in a 1‐day network meeting at the end of the year. The year‐long project resulted in five recommendations related to developing the network, enhancing community engagement, addressing regulatory challenges, advancing information technology, and developing research methods. The recommendations can be implemented within 24 months and are designed to lead toward a sustained national infrastructure for pragmatic trials.     

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.     

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     

Developing Common Metrics for the Clinical and Translational Science Awards (CTSAs): Lessons Learned

The National Institutes of Health (NIH) Roadmap for Medical Research initiative, funded by the NIH Common Fund and offered through the Clinical and Translational Science Award (CTSA) program, developed more than 60 unique models for achieving the NIH goal of accelerating discoveries toward better public health. The variety of these models enabled participating academic centers to experiment with different approaches to fit their research environment. A central challenge related to the diversity of approaches is the ability to determine the success and contribution of each model. This paper describes the effort by the Evaluation Key Function Committee to develop and test a methodology for identifying a set of common metrics to assess the efficiency of clinical research processes and for pilot testing these processes for collecting and analyzing metrics. The project involved more than one‐fourth of all CTSAs and resulted in useful information regarding the challenges in developing common metrics, the complexity and costs of acquiring data for the metrics, and limitations on the utility of the metrics in assessing clinical research performance. The results of this process led to the identification of lessons learned and recommendations for development and use of common metrics to evaluate the CTSA effort.     

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. Clin Trans Sci 2012; Volume 5: 476–479     

Developing a Practice‐Based Research Network by Integrating Quality Improvement: Challenges and Ingredients for Success

Improving patient outcomes in community‐based settings is the goal of both the Clinical Translational Science Award program and practice‐based quality improvement (QI) programs. Given this common goal, integrating QI and outcomes research is a promising strategy for developing, implementing, and evaluating clinical interventions. This article describes the challenges and strengths illuminated by the conduct of a combined research/QI study in a nascent practice‐based research network. Challenges include research''s exclusion of clinic patients who might benefit from the intervention; QI programs’ less uniform approach to intervention implementation; and the need for both academic and clinically relevant products and publications. A major strength is the increased likelihood of both engaging clinical practices in research and developing successful clinical interventions. Required elements for success include identification of enthusiastic clinical research “champions,” involvement of researchers with clinical experience, and adequate funding to support both research and clinical resources and dissemination. Combined Ql/research projects in the practice‐based research environment have the potential to improve and shorten the cycle from good idea to improved clinical outcomes in real‐world settings. Clin Trans Sci 2012; Volume 5: 351–355     

The CTSA as an Exemplar Framework for Developing Multidisciplinary Translational Teams

Translational science requires that scientists from multiple disciplines work together to improve the prevention, diagnosis, and treatment of human disease. Although a literature exists on the design and management of multidisciplinary teams, little has been written on multidisciplinary translational teams (MTTs). MTTs are distinct hybrid entities, with goals taken from both industry and academic models. We identified 30 design factors in 10 domains from a literature survey relevant to our MTT model: specific goals, structures, and processes. These dimensions were adapted to our own institutional environment in the selection and management of 11 MTTs that exploited resources of University of Texas Medical Branch (UTMB) Clinical and Translational Sciences Awards (CTSA). Case illustrations of two specific MTTs illustrate some of the challenges encountered and opportunities realized in terms of education and scientific advances. Network depiction of disciplinarity indicated that CTSA KRs and CTSA leadership contributed to discipline diversity especially in small (or nascent) MTTs. A separate depiction of MTT‐KR utilization indicated that data analysis, translational technologies, and novel methods were heavily utilized by MTTs, whereas other KRs contributed significant effort to infrastructure development. We conclude that the CTSA can provide a rich
infrastructural framework and scientific environment for the development of successful MTTs. Clin Trans Sci 2013; Volume 6: 60–71