Translational Science Award Consortium Research Articles

555 Design Lab Methodology Supports Innovation in Clinical Trials

OBJECTIVES/GOALS: Since 2017, we have used the Design Lab methodology to support investigators taking innovative approaches to clinical effectiveness trial design. To date we have held 12 Design Labs and this year we are creating a handbook that will support dissemination of this approach across the Clinical and Translational Science Award consortium. METHODS/STUDY POPULATION: The Clinical Trial Design Lab brings together a multi-stakeholder group to consider innovative and impactful clinical trial designs. An investigative team is selected from a competitive pool of applicants, after which expert-led consultations support the investigator team to think about evidence generation in the context of the full treatment development pathway. Teams map the stakeholders at each step of this pathway (e.g. clinicians, patients, researchers, funders, industry experts, policy experts, regulatory experts, payers) and consider innovative design solutions. These consultations prepare investigators for an event that involves all stakeholders in a structured and facilitated discussion about trial designs that generate the best evidence and increase potential for health impact. RESULTS/ANTICIPATED RESULTS: The result of our work will be a set of Design Lab principles, a handbook with templates that support stakeholder mapping and structured discussions, and educational resources to accompany the handbook. The work is supported by a literature review that characterizes the multi-component processes included in the Design Lab, situates them within the larger context of team science interventions, and lays groundwork for the development of process metrics and impact evaluation criteria to assess the Design Lab method. In this poster presentation, we will share our multi-component broadly engaged team science approach, provide a brief outline of the principles and educational resources, and include an early version of the evaluation criteria. DISCUSSION/SIGNIFICANCE: Broadly engaged team science supports innovative thinking about study design and is especially important in the development of clinical trials. We have grown the Design Lab program of work over the past seven years and are now able to characterize our team science methodology and support others to use this approach to innovate for health impact.

Implementation and Evaluation of a National Well-Being Curriculum for KL2 Scholars.

Introduction: The study aimed to pilot test a well-being curriculum for KL2 scholars to be used across the Clinical and Translational Science Award consortium. Methods: Between November 2022, and May 2023, 36 KL2 scholars from 25 hubs participated in the program. The General Well-Being Index for U.S. Workers and the Patient Reported Outcomes Measurement Information System (PROMIS-29) were completed by scholars before and after the program. Results: Postparticipation, there was a trend of improvement in the domains of well-being, sleep, anxiety, and fatigue. Conclusion: Implementing a virtual synchronous well-being curriculum allowed the scholars to connect across the consortium and improve their well-being.

Translation in action: Influence, collaboration, and evolution of COVID-19 research with Clinical and Translational Science Awards consortium support.

The National Institutes of Health (NIH)'s Clinical and Translational Science Awards (CTSA) consortium aims to accelerate translational processes that move discoveries from bench to bedside. The coronavirus disease 2019 (COVID-19) pandemic presented unmatched challenges and applications for CTSA hubs nationwide. Our study used bibliometrics to assess features of COVID-19 publications supported by the national CTSA program to characterize the consortium's response to the pandemic. Our goal was to understand relative scientific influence, collaboration across hubs, and trends in research emphasis over time. We identified publications from NIH's curated iSearch COVID-19 Publication Portfolio from February 2020 to February 2023; 3234 peer-reviewed articles relevant to COVID-19 cited a CTSA grant. All 66 CTSA hubs were represented, with large-size and longstanding hubs contributing more publications. Most publications cited UL1 grants, 457 cited KL2/TL1 training grants, and 164 cited multiple hub grants. Compared to a random sample of non-CTSA-supported COVID-19 publications, the CTSA portfolio exhibited greater clinical relevance, more human research, and higher altmetric and citation influence. Results were similar for multi-hub publications involving networked initiatives like multi-site clinical trials or the National COVID-19 Cohort Collaborative. Shifts from molecular/cellular-oriented research toward human-oriented research over time were evident, demonstrating translation in action. Results illuminate how the CTSA consortium confronted the pandemic through high-quality projects oriented toward human research, working across hubs on high-value collaborations, advancing along the translational spectrum over time. Findings validate CTSA hubs as critical support structures during health emergencies.

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

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

Implementing measurable goals for diversity, equity, and inclusion in Clinical and Translational Science Awards leadership

Charting a benchmarking strategy is recommended to measure improvements in equal leadership opportunities for minorities and women in the Clinical Translational Science Awards Consortium (CTSAs). Academic institutions that support diversity, equity, and inclusion (DEI) initiatives should demonstrate a willingness to track their progress with established metrics. In the fall of 2020, the CTSAs convened a virtual conference, which started a dialogue on developing measurable objectives to ensure accountability for DEI goals. Using qualitative and quantitative data from breakout sessions, the authors analyze participant responses to the following recommendation, “ develop a common metric and dashboard with regular reporting on diversity in CTSA leadership, with an emphasis on increasing female and Black Indigenous, People Of Color (BIPOC) representation to 30% each,” to understand the impact and challenges associated with implementing metrics within CTSAs. Thematic analysis revealed that white supremacist culture and demographic composition are obstacles to establishing metrics. Participants expressed uncertainty about the perception of token roles. Additionally, participants believed that DEI targets can increase diversity in perspectives and approaches to translational science. Implications for CTSAs include establishing CTSA-wide benchmarks for DEI initiatives, which includes a baseline of the existing DEI climate to assess institutional norms and measurable objectives to track progress.

The Evolve to Next-Gen ACT Network: An evolving open-access, real-world data resource primed for real-world evidence research across the Clinical and Translational Science Award Consortium.

The ACT Network was funded by NIH to provide investigators from across the Clinical and Translational Science Award (CTSA) Consortium the ability to directly query national federated electronic health record (EHR) data for cohort discovery and feasibility assessment of multi-site studies. NIH refunded the program for expanded research application to become "Evolve to Next-Gen ACT" (ENACT). In parallel, the US Food and Drug Administration has been evaluating the use of real-world data (RWD), including EHR data, as sources of real-world evidence (RWE) for its regulatory decisions involving drug and biological products. Using insights from implementation science, six lessons learned from ACT for developing and sustaining RWD/RWE infrastructures and networks across the CTSA Consortium are presented in order to inform ENACT's development from the outset. Lessons include intentional institutional relationship management, end-user engagement, beta-testing, and customer-driven adaptation. The ENACT team is also conducting customer discovery interviews with CTSA hub and investigators using Innovation-Corps@NCATS (I-Corps™) methodology for biomedical entrepreneurs to uncover unmet RWD needs. Possible ENACT value proposition hypotheses are presented by stage of research. Developing evidence about methods for sustaining academically derived data infrastructures and support can advance the science of translation and support our nation's RWD/RWE research capacity.

Aligning community-engaged research competencies with online training resources across the Clinical and Translational Science Award Consortium.

The extent to which Clinical and Translational Science Award (CTSA) programs offer publicly accessible online resources for training in community-engaged research (CEnR) core competencies is unknown. This study cataloged publicly accessible online CEnR resources from CTSAs and mapped resources to CEnR core competency domains. Following a search and review of the current literature regarding CEnR competencies, CEnR core competency domains were identified and defined. A systematic review of publicly accessible online CEnR resources from all 64 current CTSAs was conducted between July 2018 and May 2019. Resource content was independently reviewed by two reviewers and scored for the inclusion of each CEnR core competency domain. Domain scores across all resources were assessed using descriptive statistics. Eight CEnR core competency domains were identified. Overall, 214 CEnR resources publicly accessible online from 35 CTSAs were eligible for review. Scoring discrepancies for at least one domain within a resource initially occurred in 51% of resources. "CEnR methods" (50.5%) and "Knowledge and relationships with communities" (40.2%) were the most frequently addressed domains, while "CEnR program evaluation" (12.1%) and "Dissemination and advocacy" (11.2%) were the least frequently addressed domains. Additionally, challenges were noted in navigating CTSA websites to access CEnR resources, and CEnR competency nomenclature was not standardized. Our findings guide CEnR stakeholders to identify publicly accessible online resources and gaps to address in CEnR resource development. Standardized nomenclature for CEnR competency is needed for effective CEnR resource classification. Uniform organization of CTSA websites may maximize navigability.

Scale-up of the Accrual to Clinical Trials (ACT) network across the Clinical and Translational Science Award Consortium: a mixed-methods evaluation of the first 18 months.

The Clinical and Translational Science Award (CTSA) Program is a Consortium of nearly 60 academic medical research centers across the USA and a natural network for evaluating the spread and uptake of translational research innovation across the Consortium. Dissemination of the Accrual to Clinical Trials (ACT) Network, a federated clinical informatics data network for population-based cohort discovery, began January 2018 across the Consortium. Diffusion of innovation theory guided dissemination design and evaluation. Mixed-methods assessed the spread and uptake across the Consortium through July 1, 2019 (n = 48 CTSAs). Methods included prospective time activity tracking (Kaplan-Meier curves), and survey and qualitative interviews. Within 18 months, nearly 80% of CTSAs had joined the data network and two-thirds of CTSAs achieving technical readiness had initiated launch to local clinical investigators. Over 10,000 ACT Network queries are projected for 2019; and by 2020, nearly all CTSAs will have joined the network. Median time-from-technical-readiness-to-local-launch was 154 days (interquartile range: 87-225 days]. Quality improvement processes reduced time-to-launch by 35.2% (64 days, p = 0.0036). Lessons learned include: (1) conceptualize dissemination as two-stage adoption demonstrating value for both CTSA hub service providers and clinical investigators; (2) include institutional trial into dissemination strategies so CTSA hubs can refine internal workflows and gather local user feedback endorsement; (3) embrace designing-for-dissemination during technology development; and (4) sustain adaptive dissemination and customer relationship management to keep CTSA hubs and users engaged. Scale-up and spread of the ACT Network provides lessons learned for others disseminating innovation across the CTSA Consortium. The Network is primed for embedded implementation research.

4366 Aligning community-engaged research competencies with online training resources across the Clinical and Translational Science Award Consortium

OBJECTIVES/GOALS: The extent that Clinical and Translational Science Award (CTSA) programs offer resources accessible online for training in community-engaged research (CEnR) core competencies is unknown. This study cataloged CEnR resources accessible online from CTSAs and mapped resources to CEnR core competencies. METHODS/STUDY POPULATION: Eight domains of CEnR core competencies were identified: knowledge/perceptions of CEnR; personal traits necessary for CEnR; knowledge of/relationships with communities; training for performing CEnR; CEnR methods; program evaluation; resource sharing and communication; and dissemination and advocacy. A systematic review of CEnR resources accessible online from CTSAs was conducted between July 2018 and May 2019. Resource content was independently reviewed by two reviewers and scored for inclusion of each domain of CEnR core competencies. Domain scores across all resources and inter-rater reliability in scoring domains were assessed using descriptive statistics and Cohen’s kappa coefficients. RESULTS/ANTICIPATED RESULTS: Overall, 214 resources available from 24 CTSAs were eligible for full review. Scoring discrepancies for at least one domain within a resource initially occurred in 51% of resources. “CEnR methods” (50.5%; 108 of 214) and “Knowledge of/relationships with the community” (40.2%; 86 of 214) were most frequently addressed and “Program evaluation” (12.1%; 26 of 214) and “Dissemination and advocacy” (11.2%; 24 of 214) were least frequently addressed domains. Additionally, challenges were noted in navigating CTSA websites to access CEnR resources, and CEnR competency nomenclature was not standardized. DISCUSSION/SIGNIFICANCE OF IMPACT: Our findings guide CEnR stakeholders to identify CEnR resources accessible online and gaps to address in CEnR resource development. Standardized nomenclature for CEnR competencies is needed for effective CEnR resource classification. Uniform organization of CTSA websites may maximize navigability. CONFLICT OF INTEREST DESCRIPTION: In addition to the funding information listed previously (see above), within the last three years, R.J. Piasecki has been employed as: Project Coordinator, CEnR Online Learning Project, Johns Hopkins University School of Nursing (Current) Temporary Employee (Doctoral Student Intern), Michigan State University Institute for Health Policy (Current) Clinical RN, Intrastaff at the Johns Hopkins Health System (Past) Research Data Analysis Assistant, Maryland Institute for Emergency Medical Services (Past - contracted)

Accrual to Clinical Trials (ACT): A Clinical and Translational Science Award Consortium Network.

The Accrual to Clinical Trials (ACT) network is a federated network of sites from the National Clinical and Translational Science Award (CTSA) Consortium that has been created to significantly increase participant accrual to multi-site clinical trials. The ACT network represents an unprecedented collaboration among diverse CTSA sites. The network has created governance and regulatory frameworks and a common data model to harmonize electronic health record (EHR) data, and deployed a set of Informatics for Integrating Biology and the Bedside (i2b2) data repositories that are linked by the Shared Health Research Information Network (SHRINE) platform. It provides investigators the ability to query the network in real time and to obtain aggregate counts of patients who meet clinical trial inclusion and exclusion criteria from sites across the United States. The ACT network infrastructure provides a basis for cohort discovery and for developing new informatics tools to identify and recruit participants for multi-site clinical trials.

A survey of practices for the use of electronic health records to support research recruitment.

Electronic health records (EHRs) provide great promise for identifying cohorts and enhancing research recruitment. Such approaches are sorely needed, but there are few descriptions in the literature of prevailing practices to guide their use. A multidisciplinary workgroup was formed to examine current practices in the use of EHRs in recruitment and to propose future directions. The group surveyed consortium members regarding current practices. Over 98% of the Clinical and Translational Science Award Consortium responded to the survey. Brokered and self-service data warehouse access are in early or full operation at 94% and 92% of institutions, respectively, whereas, EHR alerts to providers and to research teams are at 45% and 48%, respectively, and use of patient portals for research is at 20%. However, these percentages increase significantly to 88% and above if planning and exploratory work were considered cumulatively. For most approaches, implementation reflected perceived demand. Regulatory and workflow processes were similarly varied, and many respondents described substantive restrictions arising from logistical constraints and limitations on collaboration and data sharing. Survey results reflect wide variation in implementation and approach, and point to strong need for comparative research and development of best practices to protect patients and facilitate interinstitutional collaboration and multisite research.

Staying Connected: Recommendations by Older Adults Concerning Community Leisure Service Delivery

Communities have long recognized their role in supporting and assisting older adults by offering information and services to meet their needs and address challenges of aging (United States Older Americans Act of 1965). Involving community members in the research process, often referred to as community-engaged research, is a valuable strategy for improving health (Clinical and Translational Science Awards Consortium, 2011). Recently, our research team began a project to learn how to promote engagement of local older adults in places where they usually congregate (Dattilo et al., 2015; Dattilo, Mogle, Lorek, Freed, & Frysinger, in press). We wanted to understand older adult health concerns and develop programs that assist them in maintaining health and pursuing leisure. During focus groups and a public meeting conducted during 2014 and 2015 in rural Pennsylvania, the research team listened and learned about concerns related to challenges of aging and the pursuit of healthy lifestyles that embrace leisure. Through this community-engaged process, the team gained insight into ways to improve service delivery and develop effective programs. The purpose of this paper is to present a synthesis of recommendations made by this group of older adults for developing and providing age-appropriate resources and leisure services across multiple community settings. Participants requested informational resources and identified ways they wanted to have this information delivered; such information might assist service providers in identifying what and how to provide information to community elders. They described services of interest as they specified desirable program content, program site characteristics, and the social culture when they attend leisure programs. Data were analyzed across categories resulting in identification of themes that provided perspective on overarching participant concerns and orientations. Based on these results, leisure service providers are encouraged to help older adults’ access resources and services and demonstrate flexibility when attempting to facilitate such access. Once participants engage in programs it may be valuable to promote and support social connections as they experience enjoyment and meaning. Services that provide opportunities for self development that facilitate learning and growth were perceived as important. Overall, the impact of participating in leisure services may result in valued contributions that older adults make to the health and well-being of themselves and others. Information reported in this paper is specifically intended for leisure service providers to consider when attempting responding to the desires and needs of older adults that reside within their community. Subscribe to JPRA

Bringing it home: expanding the local reach of dissemination and implementation training via a university-based workshop.

BackgroundCurrently, national training programs do not have the capacity to meet the growing demand for dissemination and implementation (D&I) workforce education and development. The Colorado Research in Implementation Science Program (CRISP) developed and delivered an introductory D&I workshop adapted from national programs to extend training reach and foster a local learning community for D&I.MethodsTo gauge interest and assess learning needs, a pre-registration survey was administered. Based on feedback, a 1.5-day workshop was designed. Day 1 introduced D&I frameworks, strategies, and evaluation principles. Local and national D&I experts provided ignite-style talks on key lessons followed by panel discussion. Breakout sessions discussed community engagement and applying for D&I grants. A workbook was developed to enhance the training and provided exercises for application to an individual’s projects. Day 2 offered expert-led mentoring sessions with selected participants who desired advanced instruction. Two follow-up surveys (immediate post-workshop, 6 months) assessed knowledge gained from participation and utilization of workshop content.ResultsNinety-three workshop registrants completed an assessment survey to inform workshop objectives and curriculum design; 43 % were new and 54 % reported a basic understanding of the D&I field. Pre-registrants intended to use the training to “apply for a D&I grant” (73 %); “incorporate D&I into existing projects” (76 %), and for quality improvement (51 %). Sixty-eight individuals attended Day 1; 11 also attended Day 2 mentoring sessions. In the 1-week post-workshop survey (n = 34), 100 % strongly agreed they were satisfied with the training; 97 % strongly agreed the workshop workbook was a valuable resource. All Day 2 participants strongly agreed that working closely with faculty and experts increased their overall confidence. In the 6-month follow-up evaluation (n = 23), evidence of new D&I-related manuscripts and grant proposals was found. Training materials were published online (www.ucdenver.edu/implementation/workshops) and disseminated via the National Institutes of Health (NIH) Clinical and Translational Science Awards Consortium. To sustain reach, CRISP adapted the materials into an interactive e-book (www.CRISPebooks.org) and launched a new graduate course.ConclusionsLocal D&I training workshops can extend the reach of national training programs.

Recommendations From the Investigational New Drug/Investigational Device Exemption Task Force of the Clinical and Translational Science Award Consortium

ObjectiveThe objective of this study was to provide recommendations for provision of training for sponsor and investigators at Academic Health Centers.BackgroundA subgroup of the Investigational New Drug/Investigational Device Exemption (IND/IDE)...

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.

A logic model for community engagement within the Clinical and Translational Science Awards consortium: can we measure what we model?

The Clinical and Translational Science Award (CTSA) initiative calls on academic health centers to engage communities around a clinical research relationship measured ultimately in terms of public health. Among a few initiatives involving university accountability for advancing public interests, a small CTSA workgroup devised a community engagement (CE) logic model that organizes common activities within a university-community infrastructure to facilitate CE in research. Whereas the model focuses on the range of institutional CE inputs, it purposefully does not include an approach for assessing how CE influences research implementation and outcomes. Rather, with communities and individuals beginning to transition into new research roles, this article emphasizes studying CE through specific relationship types and assessing how expanded research teams contribute to the full spectrum of translational science.The authors propose a typology consisting of three relationship types-engagement, collaboration, and shared leadership-to provide a foundation for investigating community-academic contributions to the new CTSA research paradigm. The typology shifts attention from specific community-academic activities and, instead, encourages analyses focused on measuring the strength of relationships through variables like synergy and trust. The collaborative study of CE relationships will inform an understanding of CTSA infrastructure development in support of translational research and its goal, which is expressed in the logic model: better science, better answers, better population health.

Clinical and translational scientist career success: metrics for evaluation.

Despite the increased emphasis on formal training in clinical and translational research and the growth in the number and scope of training programs over the past decade, the impact of training on research productivity and career success has yet to be fully evaluated at the institutional level. In this article, the Education Evaluation Working Group of the Clinical and Translational Science Award Consortium introduces selected metrics and methods associated with the assessment of key factors that affect research career success. The goals in providing this information are to encourage more consistent data collection across training sites, to foster more rigorous and systematic exploration of factors associated with career success, and to help address previously identified difficulties in program evaluation.

Strengthening the Career Development of Clinical Translational Scientist Trainees: A Consensus Statement of the Clinical Translational Science Award (CTSA) Research Education and Career Development Committees

The challenges for scholars committed to successful careers in clinical and translational science are increasingly well recognized. The Education and Career Development (EdCD) of the national Clinical and Translational Science Award consortium gathered thought leaders to propose sustainable solutions and an agenda for future studies that would strengthen the infrastructure across the spectrum of pre- and postdoctoral, MD and PhD, scholars. Six consensus statements were prepared that include: (1) the requirement for career development of a qualitatively different investigator; (2) the implications of interdisciplinary science for career advancement including institutional promotion and tenure actions that were developed for discipline-specific accomplishments; (3) the need for long-term commitment of institutions to scholars; (4) discipline-specific curricula are still required but curricula designed to promote team work and interdisciplinary training will promote innovation; (5) PhD trainees have many pathways to career satisfaction and success; and (6) a centralized infrastructure to enhance and reward mentoring is required. Several themes cut across all of the recommendations including team science, innovation, and sustained institutional commitment. Implied themes include an effective and diverse job force and the requirement for a well-crafted public policy that supports continued investments in science education.

Integrating Economic Evaluation Methods Into Clinical and Translational Science Award Consortium Comparative Effectiveness Educational Goals

With the ongoing debate over health care reform in the United States, public health and policy makers have paid growing attention to the need for comparative effectiveness research (CER). Recent allocation of federal funds for CER represents a significant move toward increased evidence-based practice and better-informed allocation of constrained health care resources; however, there is also heated debate on how, or whether, CER may contribute to controlling national health care expenditures. Economic evaluation, in the form of cost-effectiveness or cost-benefit analysis, is often an aspect of CER studies, yet there are no recommendations or guidelines for providing clinical investigators with the necessary skills to collect, analyze, and interpret economic data from clinical trials or observational studies. With an emphasis on multidisciplinary research, the Clinical and Translational Science Award (CTSA) consortium and institutional CTSA sites serve as an important resource for training researchers to engage in CER. In this article, the authors discuss the potential role of CTSA sites in integrating economic evaluation methods into their comparative effectiveness education goals, using the Columbia University Medical Center CTSA as an example. By allowing current and future generations of clinical investigators to become fully engaged not only in CER but also in the economic evaluations that result from such analyses, CTSA sites can help develop the necessary foundation for advancing research to guide clinical decision making and efficient use of limited resources.

Reengineering the National Clinical and Translational Research Enterprise: The Strategic Plan of the National Clinical and Translational Science Awards Consortium

Advances in human health require the efficient and rapid translation of scientific discoveries into effective clinical treatments; this process, in turn, depends on observational data gathered from patients, communities, and public health research that can be used to guide basic scientific investigation. Such bidirectional translational science, however, faces unprecedented challenges due to the rapid pace of scientific and technological development, as well as the difficulties of negotiating increasingly complex regulatory and commercial environments that overlap the research domain. Further, numerous barriers to translational science have emerged among the nation's academic research centers, including basic structural and cultural impediments to innovation and collaboration, shortages of trained investigators, and inadequate funding.To address these serious and systemic problems, in 2006 the National Institutes of Health created the Clinical and Translational Science Awards (CTSA) program, which aims to catalyze the transformation of biomedical research at a national level, speeding the discovery and development of therapies, fostering collaboration, engaging communities, and training succeeding generations of clinical and translational researchers. The authors report in detail on the planning process, begun in 2008, that was used to engage stakeholders and to identify, refine, and ultimately implement the CTSA program's overarching strategic goals. They also discuss the implications and likely impact of this strategic planning process as it is applied among the nation's academic health centers.