203 Deconstructing the institutional data Maze to Develop CRP Employment Data Reporting and Evaluation

Career Development of Physician Scientists: A Survey of Leaders in Academic Medicine

In 2006, the National Institutes of Health (NIH), guided by the leadership of Elias Zerhouni, launched the Clinical and Translational Science Award (CTSA) program to jump-start transformative change in the nation’s research agenda to emphasize translating discovery from the bench to implementation in the community.1-5 Much of the funding for the CTSAs was garnered by rolling NIH funding of General Clinical Research Centers and educational K and T awards. Successful applicants were then asked to utilize these funds to (as stated in the Request for Applications) “transform the local, regional and national environments for clinical and translational science and to increase the safety, efficiency and speed of clinical and translational research.”4 Each of the 60 CTSA institutions has approached addressing this transformation in slightly different ways; however, it has become clear over the last 5 years that substantive changes, as a result of CTSA funding at academic institutions, are transforming medical research and the infrastructure that supports it. Each of the CTSA’s is required to address specific key functions to advance the consortium goals. These required key functions are (1) expertise in Biomedical Informatics, (2) a program in Research Education, Training, and Career Development, (3) a program in Community Engagement and Research, (4) an Evaluation component, (5) Pilot Projects in Translational and Clinical Studies, and (6) a Regulatory Knowledge and Support component. Optional CTSA key functions include (1) support of the Development of Novel Clinical and Translational Methodologies, (2) components or cores to support Research Design, Epidemiology, Biostatistics, and Clinical Research Ethics, (3) Clinical Research Resources and Facilities, and (4) components or cores that develop Translational Technologies and Resources. It is also encouraged for institutions to support research in Child Health. Addressing these key functions at the University of Michigan, for example, has led to transformational change in the structure and culture of the institution. After receiving a CTSA award in 2007, the University of Michigan (U-M) conducted a strategic assessment of the translational research enterprise through over 100 extensive interviews of faculty and staff providing the infrastructure for translational research, as well as the investigators conducting that research. The institution then conducted a survey of research team members involved in human subject research to identify and describe the current challenges facing translational research—specifically, the administrative processes associated with its planning and execution. In addition to identifying the issues, the team rated the technical and cultural/political levels of difficulty in implementing the solutions, as well as the corresponding impact each solution would potentially bring. These were then graphically mapped on a three-dimensional bubble chart (Figure 1). This stratification assisted in the planning, design, and prioritization of solutions, offering insights that guide the refinement efforts of a clinical research enterprise’s organization, business, and information technology (IT) processes. Bubble chart of implementation complexity. The chart orders tasks by level of execution difficulty—both technical and fiscal execution difficulty—as well as organizational and cultural complexity. The bubble size represents impact such that the bigger the bubble, the bigger the impact the change will have on improving translational research. For instance, enhancing study coordinator programs is relatively easy both technically and from an institutional buy-in perspective and was judged to provide a relatively large impact. Creating integrated informational technology systems involves significant investment, is more technically complex, requiring buy-in from multiple parties within the institution but is pivotal for achieving the goal of doing more effective translational research. The visual mapping provides context and definition to the challenge of enhancing the efficiency and effectiveness of translational research not only at the University of Michigan but all of the CTSAs. IT = Information Technology, CTSU = Clinical Trials Support Unit. Eight areas were identified as solution categories. The topics include organizational, procedural, financial, structural, educational, technological, and cultural elements. Transform and expedite study and contract approval process. The contract approval process, especially in regard to industry protocols, was recognized by the faculty as their number one area of discontent. The approval process was not clear to research team members and varied widely by unit and department as well as by type of sponsor. Educational and process improvement opportunities were identified. To address these issues, U-M has set a goal to expedite study approval process so that the contract and regulatory processes are executed within 60 days from submission for all studies and 45 days for industry-sponsored studies. The primary strategy to accomplish this aggressive goal was to create a team consisting of members of the units involved and to reengineer processes and conduct a demonstration project for feasibility within 1 year. Secondary strategies included increasing the transparency of contracting within the system to allow better tracking of proposals by the faculty and study teams, publishing desirable contract terms on a website for faculty and staff to use as protocols are developed, and to create an interactive, web-based research road map to guide faculty and staff through the necessary administrative steps to conduct translational research.6 Establish a clinical research support unit with best practice tools. The current translational research enterprise consists of multiple units with redundant functions of varying quality. The primary strategy was to create a leveraging of the resources of the CTSA to develop a franchisable model built on best practice modules that could then be easily adopted by other units throughout the university. Develop a customer friendly, transparent financial system that spans clinical trial budget creation to account reconciliation and study close out. The lack of transparent and integrated financial systems to track costs and other financial aspects of clinical research including budgeting and billing remains a challenge for study team members. The University of Michigan Office of Research has created the Calendar Review and Analysis Office (CRAO) to assist researchers with this process and is currently implementing a clinical study budget tool, eThority, to create standard billing calenders and processes across the organization. CRAO will also champion the evaluation of financial feasibility prior to proposal initiation; provide more assistance to PIs and research team members with study budgets, through increased training on best practices, budget negotiators, and standardized internal budget; and generate a new reconciliation report that will make study account statements more easily understood by research teams. Improve regulatory approval process and reduce Institutional Review Board (IRB) turn-around time. Significant gains have been made, resulting in a 40% improvement in IRB cycle time. Study teams will be advantaged by continuous improvements to the process. Embedded within the goal to expedite study approval is the goal to reduce IRB turnaround time (TAT) to 21 days for full convened board approval, including ancillary committees, and reduce no more than minimal risk studies to 5 days TAT. U-M is investigating strategies for greater IRB board participation of faculty, instituting another IRB board specifically for industry-based studies, as well as dedicating a board to minimal risk studies. The CTSA is also identifying various research teams to extract best practices. The CTSA has created an IND/IDE consultation and support team for researchers that have already helped over 100 investigators with IND/IDE applications. Create a home for study coordinators to promote education and sharing of best practices. A strong research team, anchored by a solid study coordinator, is critical to clinical research success. Study coordinator turnover was noted to be 18% a year. Of all study coordinators, 75% have been at U-M less than 3 years, compared to 44% of the rest of U-M staff and 56% of study coordinators nationally. Study coordinators noted that there was no coherent program or “home” for them within the system. Several strategies have been developed and are being enacted to address this problem. The CTSA created a virtual, web-based site for study coordinator support that will eventually include standardized resources such as workflow steps, templates, forms, and answers to common questions. A monthly study coordinator forum has been enacted to share challenges and best practices. Human resources has been engaged to develop uniform study coordinator job descriptions and to mentor the coordinators to develop a meaningful career path. Increase patient participation (enrollment) in research. The institution has set an ambitious goal to double patient participation in research in 5 years, while decreasing the number of studies that do not enroll a subject to 5%. A primary strategy to accomplish this was the creation of a web-based participant registry (UMclinicalstudies.org) to help match interested patients and volunteers with open studies. Currently, over 7,000 participants are registered. U-M is also investing in an electronic medical record system that better enables queries and “flags” potentially eligible patients. Further investigation by a study team is necessary to determine the underlying reasons for poor accrual to studies, whether due to missed competitive enrollment periods, rare disease studies that inherently will be challenged to accrue, registry studies with open enrollment, lack of ability to find enough patients within the patient population, or unwillingness to ask patients to participate. Understanding and addressing the underlying issues provides an opportunity for the CTSA to improve the quality, and potentially reduce “waste,” in the proposal and regulatory systems. Achieve efficiencies through integration of multiple, fragmented IT systems. More than 30 IT systems, as well as paper records, were identified that are currently utilized by investigators to perform clinical and translational research. Moreover, multiple IT service providers exist across the institution with poorly defined roles, responsibilities, and accountability. Alignment of key IT systems and personnel that support clinical and translational research is imperative. The CTSA is playing a central role in developing and leading a cohesive strategy that integrates IT for researchers’ benefits. For example, the institution is investing in a system-wide approach to develop an overall architecture that will create a clinical data repository. Evolve the culture of U-M to be more supportive and enthusiastic of clinical research. Like many academic institutions, the University of Michigan has struggled to value clinical research to the same extent as the basic sciences. In interviews and surveys, many faculty noted that choosing a career in clinical research can be seen as “falling between the cracks” or not as respected as a career in basic research. While improving infrastructure demonstrates value to these researchers, it is not enough. The CTSA has advocated to create a working group to make recommendations to University leadership to increase recognition for excellence in clinical research, to refine promotion and incentive criteria to value scholarly clinical activity and emphasize collaboration and innovation across all disciplines (team science). Furthermore, a plan is being developed to expand training programs to support training of those who want to become clinical and translational researchers, beyond the few slots that the CTSA (K and T programs) can currently support. The mission of the CTSA to enhance an investigator’s ability to conduct translational research at the University of Michigan has resulted in concrete organizational plans and investments to improve infrastructure of translational research and increase the satisfaction of participants, faculty, and staff who are engaged in these activities.7 Similar changes are occurring at CTSA institutions all over the country, validating the vision of Dr. Zerhouni and the investment in these vehicles of change by the NIH. Supported by UL 1RR024986 NIH/NCRR—Clinical and Translation Science Award.

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 non-responders’ CTSA web sites. Results: Thirty-two of 53 CC-CHOC members (60%) responded and all non-responder websites were reviewed. Institutions supported 1166 CDA positions from 2006–2011, 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 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.

SCTS was established in 2008 with the mission of advancing research and education in CTS so as to improve human health. Since CTS research is a cross-cutting enterprise, SCTS will focus on the multidisciplinary processes of conducting CTS research rather than on the results in any specific scientific area or disease. As the missions of many different professional societies overlap SCTS's mission and SCTS recognizes and respects the contributions that these societies have made in advancing the discipline of CTS, SCTS is eager to join with these societies in the common cause of advancing the field. By serving as the bridge between scientific discoveries and improved diagnosis, therapy, and prevention of human disease, CTS research differs from basic science discovery, which focuses on the generation of new knowledge without regard to its immediate application to medicine. The primary objective of CTS research is the improvement of human health at both the individual and community levels. Viewed from an economic perspective, CTS research is also essential for the success of the pharmaceutical, biotechnology, and medical device industries, facilitating the conversion of scientif c discoveries into new drugs and devices, and creating new jobs that derive from the manufacture, sales, and distribution of the drugs and devices. CTS research also has a role in national defense, including the development of methods to diagnose and treat diseases caused by biologic weapons. Thus, CTS is essential for achieving many of the goals the public expects from its investment in medical research through support of the National Institutes of Health (NIH). The creation by the NIH of the Clinical and Translational Science Award (CTSA) program in 2006 dramatically heightened awareness of the discipline of CTS in academic institutions, industry, and philanthropy, as well as among the broader public and the policy makers at local, state, and national levels. With its focus on developing and augmenting advanced degree-granting training programs in CTS, many of which built on the excellent curricula developed under the aegis of the NIH Clinical Research Curriculum K30 Award program, the CTSA program also provided encouragement and new resources to create imaginative educational experiences for individuals who seek careers in CTS. Based on 2007 data from the CTSAs, there are already more that 500 trainees in these programs and when the CTSA program reaches its stated goal of 60 centers, it is likely that there will be more than 1,000 trainees in these programs at any time. The past several decades have been marked by astounding advances in basic science, epitomized by the success of the human genome project and the growing “-omics” revolution. This explosion of knowledge has not, however, been matched by a comparable increase in the translation of that knowledge into new therapies. In fact, the number of truly novel drugs and biologics approved by the Food and Drug Administration each year has not substantially increased since the 1970s despite more than a 10-fold increase in inflation-adjusted investments by the pharmaceutical and biotechnology industries. While many factors Society for Clinical and Translational Science (SCTS) Governance Barry Coller (Rockefeller University) – President Harry Selker (Tufts Medical Center) – Vice President Rebecca Jackson (Ohio State University) – Secretary Anantha Shekhar (Indiana University) – Treasurer Board of Directors Robert Califf (Duke University) Marc Drezner (University of Wisconsin) Daniel Ford (Johns Hopkins University) David Guzick (University of Rochester) Gary Hunninghake (University of Iowa) Eric Orwoll (Oregon Health & Science University) Kenneth Polonsky (Washington University) Robert Sherwin (Yale School of Medicine) NIH Liaison to the Board of Directors John Gallin (NIH Clinical Center) Standing Committees Henry Ginsberg (Columbia University) – Annual Meeting Paul Marantz (Albert Einstein College of Medicine) – Annual Meeting John Gallin (NIH Clinical Center) – Membership Kenneth Polonsky (Washington University) – Nominations Philip Greenland (Northwestern University) – Publications Harry Selker (Tufts Medical Center) – Public Education & Governmental Affairs Anantha Shekhar (Indiana University) – Finance & Audit have contributed to this disappointing gap between scientifc opportunity and medical advance, one important factor is the increasing complexity of conducting CTS research. The full expression of CTS research requires the convergence of expertise across 3 dimensions. The first dimension is the multidisciplinary approach required to perform studies involving human participants. In the past a single investigator could examine a patient on the ward in the morning, take a sample back to the lab and perform an assay by midday, then return to the ward in the af ernoon and institute a novel therapy based on the experimental results. Today, such research requires the efforts of clinical research coordinators, research nurses, pharmacologists, research pharmacists, biostatisticians, bionutritionists, and clinical monitors and auditors, as a well as experts in the protection of human subjects, recruitment, community engagement, bioinformatics, and information technology. The laboratory evaluation itself requires a team approach, with a focus on advanced and expensive instrumentation and procedures commonly found only in large core facilities, supported by extensive quality control programs that meet the exacting standards for clinical laboratories. The second dimension is the continuum that extends from defining a health need, often via careful analysis of epidemiologic data, through basic investigation, preclinical evaluation, human studies, small and large scale clinical trials, analysis of clinical adoption and both therapeutic- and cost-effectiveness in the community, and, finally, returning to epidemiology. This dimension is composed of multiple bidirectional cycles, since each component contains information that potentially can advance every other component. As a result, the free flow of information across what are increasingly viewed as arbitrary boundaries is crucial for success. For example, the data from the Framingham Heart Study demonstrating the association between the risk of vascular disease and serum cholesterol levels played an important role in encouraging investigation of cholesterol metabolism at the molecular level, laying the groundwork for the development of drugs to reduce serum cholesterol levels. The third dimension links the academic community with its partners in the CTS enterprise, including granting, public health, and regulatory agencies; policy makers; the pharmaceutical, biotechnology, and medical device industries; and the philanthropic organizations that fund and support research. Most importantly, using the stem cell analogy, it is essential that the discipline of CTS has the capacity for self-renewal. A commitment to the training and mentoring of the next generation of investigative teams, as well as the support and recognition of the mentors who play the most important role in both training and career development, is crucial for the success and long-term stability of the enterprise. Fortunately, the Association for Clinical Research Training (ACRT) and the National CTSA Consortium Education and Career Development Key Function Committee recognize this need and have jointly conducted an outstanding meeting for trainees and mentors for the past several years. Become a Member For more information visit the SCTS Web site, http://www.societycts.org, or e-mail SCTS@smithbucklin.com. Based on the foregoing considerations, the immediate goal of SCTS is to conduct an annual meeting in cooperation with ACRT and the CTSA Education and Career Development Committee. The first annual meeting is scheduled for April 5-7, 2010, in Washington, DC. It is open to all individuals who participate in or support CTS in academic institutions around the world, as well as individuals from industry, government, and philanthropy. The meeting will focus on the needs of trainees and junior faculty; provide a forum for dissemination of new developments in the design and conduct of CTS research; provide a forum for leaders in governmental agencies, the private sector, and philanthropic organizations to provide updates on their programs related to CTS research; and facilitate scientific collaborations and the development of a cultural identity for the discipline through opportunities for social networking. Other societies with overlapping missions are encouraged to consider meeting in the same location and time as SCTS. SCTS was initially founded by all of the then 38 CTSA recipient institutions as well as the NIH Clinical Center. Since that time the list of founding institutions has extended beyond the CTSA program (an updated list is posted at http://www.societycts.org) and additional institutions are invited to join the list of founding institutions, which will remain open until the f rst SCTS annual meeting. To add your institution to the list of founding institutions, contact the SCTS administrator at (202) 367-1119. Governance is vested in a Board of Directors and of cers derived from institutional members and a liaison member from ACRT. The current Board of Directors, of cers, and committee chairs are listed in Table 1. CTS has been designated as an official journal of SCTS. SCTS wishes to express its deep appreciation to Arthur Feldman, MD, PhD, CTS editor-in-chief, and Danette Somers of Wiley-Blackwell for their support in establishing this relationship. As the founding president of SCTS I want to thank all of the individuals who have worked hard to convert the idea for SCTS into the reality of a newborn society, learning and adapting as it begins its journey, but filled with the excitement, enthusiasm, and expectations that uniquely mark a true new beginning. I look forward to working with each of you to make certain that SCTS achieves its remarkable potential.

Pilot projects ("pilots") are important for testing hypotheses in advance of investing more funds for full research studies. For some programs, such as Clinical and Translational Science Awards (CTSAs) supported by the National Center for Translational Sciences, pilots also make up a significant proportion of the research projects conducted with direct CTSA support. Unfortunately, administrative data on pilots are not typically captured in accessible databases. Though data on pilots are included in Research Performance Progress Reports, it is often difficult to extract, especially for large programs like the CTSAs where more than 600 pilots may be reported across all awardees annually. Data extraction challenges preclude analyses that could provide valuable information about pilots to researchers and administrators. To address those challenges, we describe a script that partially automates extraction of pilot data from CTSA research progress reports. After extraction of the pilot data, we use an established machine learning (ML) model to determine the scientific content of pilots for subsequent analysis. Analysis of ML-assigned scientific categories reveals the scientific diversity of the CTSA pilot portfolio and relationships among individual pilots and institutions. The CTSA pilots are widely distributed across a number of scientific areas. Content analysis identifies similar projects and the degree of overlap for scientific interests among hubs. Our results demonstrate that pilot data remain challenging to extract but can provide useful information for communicating with stakeholders, administering pilot portfolios, and facilitating collaboration among researchers and hubs.

BackgroundTranslational research is a key area of focus of the National Institutes of Health (NIH), as demonstrated by the substantial investment in the Clinical and Translational Science Award (CTSA) program. The goal of the CTSA program is to accelerate the translation of discoveries from the bench to the bedside and into communities. Different classification systems have been used to capture the spectrum of basic to clinical to population health research, with substantial differences in the number of categories and their definitions. Evaluation of the effectiveness of the CTSA program and of translational research in general is hampered by the lack of rigor in these definitions and their application. This study adds rigor to the classification process by creating a checklist to evaluate publications across the translational spectrum and operationalizes these classifications by building machine learning-based text classifiers to categorize these publications.MethodsBased on collaboratively developed definitions, we created a detailed checklist for categories along the translational spectrum from T0 to T4. We applied the checklist to CTSA-linked publications to construct a set of coded publications for use in training machine learning-based text classifiers to classify publications within these categories. The training sets combined T1/T2 and T3/T4 categories due to low frequency of these publication types compared to the frequency of T0 publications. We then compared classifier performance across different algorithms and feature sets and applied the classifiers to all publications in PubMed indexed to CTSA grants. To validate the algorithm, we manually classified the articles with the top 100 scores from each classifier.ResultsThe definitions and checklist facilitated classification and resulted in good inter-rater reliability for coding publications for the training set. Very good performance was achieved for the classifiers as represented by the area under the receiver operating curves (AUC), with an AUC of 0.94 for the T0 classifier, 0.84 for T1/T2, and 0.92 for T3/T4.ConclusionsThe combination of definitions agreed upon by five CTSA hubs, a checklist that facilitates more uniform definition interpretation, and algorithms that perform well in classifying publications along the translational spectrum provide a basis for establishing and applying uniform definitions of translational research categories. The classification algorithms allow publication analyses that would not be feasible with manual classification, such as assessing the distribution and trends of publications across the CTSA network and comparing the categories of publications and their citations to assess knowledge transfer across the translational research spectrum.Electronic supplementary materialThe online version of this article (doi:10.1186/s12967-016-0992-8) contains supplementary material, which is available to authorized users.

US medical researchers brace themselves for budget cuts

Organizations supporting translational research and translational science, including Clinical and Translational Science Award (CTSA) hubs, provide a diverse and often changing array of resources, support, and services to a myriad of researchers and research efforts. While a wide-ranging scope of programs is essential to the advancement of translational research and science, it also complicates a systematic and unified process for tracking activities, studying research processes, and examining impact. To overcome these challenges, the Duke University School of Medicine’s CTSA hub created a data platform, Translational Research Accomplishment Cataloguer (TRACER), that provides capacity to enhance strategic decision-making, impact assessment, and equitable resource distribution. This article reviews TRACER development processes, provides an overview of the TRACER platform, addresses challenges in the development process, and describes avenues for addressing or overcoming these challenges. TRACER development allowed our hub to conceptually identify key processes and goals within programs and linkages between programs, and it sets the stage for advancing evidence-based improvement across our hub. This platform development provides key insight into facilitators that can inform other initiatives seeking to collect and align organizational data for strategic decision-making and impact assessment. TRACER or similar platforms are additionally well positioned to advance the study of translational science.

This study uses KL2 scholars' publications to evaluate the types of research the KL2 program supports and to assess the initial productivity and impact of its scholars. We illustrate the feasibility of 3 different approaches to bibliometrics, one viable method for determining the types of research a program or hub supports, and demonstrate how these data can be further combined with internal data records. Gender differences were observed in the types of research scholars undertake. Overall KL2 scholars are performing well, with their publications being cited more than the norm for National Institutes of Health publications. Favorable results were also observed in scholars' continued engagement in research. This study illustrates that linking bibliometric data and data categorizing publications along the translational spectrum with a Clinical and Translational Science Award hub's internal data records is feasible and offers a number of innovative possibilities for the evaluation of a Clinical and Translational Science Award hub's programs and investigators.

The Clinical and Translational Science Awards (CTSA) program of the National Center for Advancing Translational Sciences (NCATS) aims to speed the process of transforming new discoveries into improvements in human health. Critical to achieving this outcome of improving human health is the engagement of community, broadly defined, across the research spectrum. Moreover, including community members who do not traditionally participate in research nor benefit from research findings, must occur. Indeed, the Institute of Medicine highlighted the importance of engagement and collaboration in its recent review of the CTSA program (IOM, 2013). Translational science is a team-based endeavor; the more diverse the team, the greater the likelihood new discoveries will benefit more people. Unique populations (age, ethnicity, gender, place, race) experience disparities in health outcomes that translational science must address. The challenge becomes one of how to minimize these disparities by harnessing the promise of translational science through the CTSA program, while bringing voices of all constituencies to the table. In the latest strategic plan to combat health disparities (HD), the NIH listed four major goals: promoting HD research; fostering innovative collaborations and partnerships; training a diverse workforce; and translating and disseminating new discoveries. It is evident that both the CTSA program and the NIH strategic HD plan emphasize the necessity to engage community. Likewise, a CTSA Advisory Work Group identified three additional strategic goals that align with the HD plan: workforce development, integration, and development of novel methods. Thus, a rather unique opportunity exists to improve human health and reduce disparities, while achieving these established goals. At the University of Wisconsin Madison (UW), we integrated a P60 Center of Excellence funded by the National Institutes for Minority Health and Health Disparities (NIMHD) within our CTSA program to create the partnership required to effectively conduct community engaged HD research. Institutional commitment, along with shared personnel, resources, and complementary expertise, are transforming the academic culture to value engagement along the entire translational research spectrum. In time, we believe “nesting” of the P60 within the CTSA will improve the health of Wisconsin citizens and increase health equity.

OBJECTIVES/SPECIFIC AIMS: A growing concern about the declining physician-scientist workforce prompted the 2014 National Institutes of Health (NIH) Physician Scientist Workforce to recommended that “tools for assessing the strength of the biomedical workforce” be developed. To aid strategic planning, the Oregon Clinical and Translational Research Institute convened key stakeholders at its home university, Oregon Health and Science University (OHSU), to survey the local landscape of physician scientists. Surprisingly, few consensus methods were available to measure and benchmark OHSU with respect to national comparators. To address this deficit, we sought to develop clear and objective metrics describing physician-scientist success at our institution. By focusing on local funding, we were able to generate more complete and robust data than others have reported. These data also permit us to compare ourselves to the national workforce, using well-curated and accessible national databases. The goal of the analyses is to contribute to strategic decision-making by portraying the local physician-scientist workforce, comparing it to the national landscape, and making recommendations about mechanisms to address potential opportunities. This has led us to develop a simple quantitative dashboard, which now permits OHSU to craft strategic targets and address successes and opportunities. These approaches are likely to be valuable elsewhere. METHODS/STUDY POPULATION: OHSU is a medium-sized academic health center in Portland, Oregon with over 1200 principal investigators and over $230M in NIH funding. The primary focus of our investigation was physician-scientists who receive extramural funding. To align with other analyses, we distinguish physician-scientists with an M.D. only, or with an M.D. and a master’s degree, from physician-scientists who hold an M.D./Ph.D. For this distinction, we use the indicator “M.D.-only” to indicate the former. The study design consisted of (a) selection of available and relevant national level data on the physician-scientist workforce, (b) curating of local level data to align it with the national indicators, (c) comparing the 2 sets of data to look for differences in trends over time, and (d) supplementing the analyses with additional local data not available at the national level. Key comparisons were tested for statistical significance and plotted on a dashboard, which was then reviewed by an OHSU internal working group focused on physician-scientists. Data elements included degrees, age, gender, and grants awarded. National data come directly from the NIH Data Book, updated for fiscal year 2016. The NIH makes all funded project data available in the publicly downloadable ExPORTER Data Catalog. These project data were used to supplement the summarized data available from the NIH Data Book, allowing us to extract OHSU investigators and to complete the K to R comparative analysis. For analyses of OHSU investigators holding funding other than RPGs, we relied on institutional data from the OHSU grants and contracts office. Demographic data on OHSU investigators were obtained from departmental and human resource records. The time period for these analyses was 1998–2016. RESULTS/ANTICIPATED RESULTS: At OHSU, as nationally, there has been an increase in RPG-holding Ph.D.s but not in RPG-holding physician-scientists. At OHSU, nearly three-fourth of physician-scientist RPGs hold an M.D.-only degree, compared with nationally, where nearly half of physician-scientists are M.D./Ph.D.s. The percent of younger, early-career, RPG-holding physician-scientists has declined precipitously at OHSU and nationally. At OHSU, the percentage of RPGs held by women physician-scientists is below the national figure. Funding sources for physician-scientists at OHSU were more diverse than for Ph.D. scientists, and physician-scientists comprise the majority of Principal Investigators on clinical trials. These non-RPG sources of funding remain a critical source of support, although local analyses of time spent on research indicate that physician-scientists with NIH funding spend a greater percentage of their time on research than those without. OHSU PI’s have had success in transitioning from K08 and K23 grants to R-level grants, with similar percentages receiving RPGs within 5 years. A dashboard comparing these trends was developed. DISCUSSION/SIGNIFICANCE OF IMPACT: There were 3 key impacts from our analyses. First, we developed and disseminated a dashboard with both local data and national comparators. Second, in consultation with institutional leadership, we selected target values to define success for each metric. Third, we recommended actions that will help OHSU meet the selected targets. A major accomplishment of this structured approach has been the identification of opportunities for change that were not recognized previously. For example, leadership was not aware of the substantial and growing deficit in female physician-scientists at OHSU, compared with the impressive increases nationally. Thus, to reduce gender disparity at OHSU, we have recommended purposeful recruitment; one approach is to target female graduates of Medical Scientist Training Programs for faculty positions, as this group has better success at achieving R-level funding than do M.D.-only applicants. Another outcome is to help set ambitious but reasonable targets for improving the local landscape. Thus, we aim to reduce the average age of RGP-holding physician-scientists at OHSU by one year during the next 5 years. Although reversing current trends will not be easy, our analyses suggest that the average age of RPG level physician-scientists at OHSU would decrease were OHSU were to match the national-level proportions of women and M.D./Ph.D. physician-scientists. In addition to targeting gender disparities, we have recently implemented a program that supplements funding for recruiting young physician scientists, and then supporting their pursuit of RPG funding. Locally, a bright spot is the K to RPG transition rate for K23 awardees, which compare favorably with national data, an outcome that we plan to maintain. In analyzing this area of success, one reason is our strong mentorship program, called OCTRI Scholars, which is provided through our CTSA-sponsored institute. This has fostered an atmosphere of success among young physician-scientists and is one of the reasons that we endorse recommendation #9 from the PSWR, suggesting that Clinical and Translational Science Award (CTSA) Institutes play pivotal roles in monitoring and enhancing the success of the physician-scientist workforce. Thus, several perceived deficiencies might be addressed with adjustment of 1 or 2 specific institutional policies. While the specific opportunities and strengths may be different at other institutions, our proposed dashboard, which couples publicly curated, freely accessible databases, with readily available institutional resources, should help institutions to set and achieve their own goals.

IMPACT: This study provides a framwork to inform and organize health equity efforts and initiatives at CTSA institutes. OBJECTIVES/GOALS: to map the activities of the Clinical and Translational Science Award (CTSA) Program hubs across the EQ-DI framework, to depict opportunities for interaction between health equity and dissemination & implementation (D&I) science. METHODS/STUDY POPULATION: The EQ-DI framework demonstrates the dynamic interaction between D&I science and health equity. Health equity could be a lens to sensitize and inform D&I planning (through goal-setting and team development), execution (through ‘adaptation’ and D&I strategies), and evaluation (through incorporating health equity in D&I outcome assessment). On the other hand, D&I models, methods, and study designs can operationalize dissemination and implementation of evidence-based interventions to improve equity. Stakeholder engagement is at the center of the framework to inform and direct the sensitization and operationalization cycles. RESULTS/ANTICIPATED RESULTS: We reviewed the activities of Colorado Clinical & Translational Sciences Institute (CCTSI) and University of Rochester Clinical and Translational Science Institute (UR CTSI) to improve health equity and mapped them across the EQ-DI framework. The sensitizing activities included health equity training, eliciting community priorities, and inclusion of health equity as a critical axis in funding mechanisms. The operationalizing activities included D&I methodological training and consultation, collaborative team science, and funding mechanisms to support implementation of health equity EBIs. Community engagement through studios, community liaisons, and consults was a core priority guiding sensitizing and operationalizing activities. DISCUSSION/SIGNIFICANCE OF FINDINGS: The CTSA Program has been a champion for community engagement and translational collaboration to improve individual and population health. CTSA hubs provide infrastructure and resources to facilitate equity-focused D&I.

The Clinical and Translational Science Award (CTSA) program has highlighted community engagement in research by requiring institutions to develop bidirectional relationships with communities to obtain funding. Little is known about how institutions have operationalized that requirement. This study aimed to describe the strategies proposed by the first institutions to receive CTSA funding and to undergo the CTSA renewal process. The authors conducted a qualitative document analysis of the community engagement section of 12 original and 10 renewal grant applications of the 12 institutions awarded CTSA funding in 2006 and renewed in 2010. Institutions employed - and research engagement strategies. Capacity-building strategies included education, pilot grants, connecting potential partners, and community research centers. Research engagement strategies ranged from those that allowed for very little input from communities, such as announcements, to those that allowed for a high amount of input from communities, such as community-researcher teams. CTSA funding has supported capacity-building for institutions and communities to partner. Engagement strategies employed by the institutions are largely known from prior community-engaged research. Based on the grants from these institutions, the CTSA funding has largely enabled institutions to develop capacity to engage.

The University of Wisconsin-Madison (UW) has served as a hub of multidisciplinary expertise in both research mentor and mentee training and evaluation, with long-standing, federally-funded efforts to support innovative practice, training interventions, and research to improve training programs for diverse scholars in science, technology, engineering, mathematics, and medicine (STEMM). Ten years ago, the Wisconsin Program for Scientific Teaching, co-directed by Drs. Pfund, Miller and Handelsman, led an effort to train future biology faculty to become more effective research mentors. Cohorts of biology graduate students, postdoctoral trainees, faculty, and staff met to discuss mentoring challenges and solutions, generating case studies and discussion questions along the way. Following evaluation and revision, these materials were published as Entering Mentoring,1 a manual to help others facilitate research mentor training seminars and workshops. Published evaluations of the Entering Mentoring seminars indicate that mentors who participate in training gain important skills.2 These trained mentors are more likely to consider issues of diversity, discuss expectations with their mentees, and to seek the advice of their peers. Entering Mentoring, since adapted to create nine different curricula that target specific STEM disciplines, has subsequently been used across the country to train hundreds of research mentors. All of these developed materials have been field-tested at UW in the Center for the Integration of Research, Teaching, and Learning (CIRTL, PI: Robert Mathieu) and are available at no charge on the project website (http://www.researchmentortraining.org). Entering Mentoring has served as a foundation and framework for the Clinical and Translational Science Award (CTSA)-funded initiatives of the UW Institute for Clinical and Translational Research (ICTR). In 2010, a multidisciplinary team from five CTSA-funded institutions, supported by a CTSA Administrative Supplement awarded UW, sought to adapt Entering Mentoring to make it applicable for the mentors of clinical and translational researchers. Over a 6-month period, the curriculum team outlined, reviewed, and adapted learning objectives and core training activities to address six research mentoring competencies: (1) maintaining effective communication; (2) aligning expectations; (3) assessing understanding; (4) addressing diversity; (5) fostering independence; and (6) promoting professional development.3 Further adaptations and beta-testing followed, with the final curriculum published as Mentor Training for Clinical and Translational Researchers.4 Using this curriculum, as designed, allows small groups of mentors to engage in a discussion of case studies and activities intended to help them meet specific learning objectives, set forth for each of the six competencies. The curriculum is typically implemented in four 2-hour sessions, led by two trained facilitators. The Mentor Training for Clinical and Translational Researchers4 curriculum was evaluated in a randomized controlled trial conducted at 16 U.S. institutions (15 CTSA sites), between January 2010 and July 2011. A total of 283 mentor-mentee pairs were recruited, with 98% retention of participants through the trial. Mentors were allocated to the 8-hour training group (n = 144) or to the control group (n = 139). We hypothesized that this systematic, formal mentor training strategy would improve mentoring skills across the six core curriculum competencies, and positively influence behaviors. Baseline and six month post randomization interviews were conducted using the validated Mentoring Competency Assessment (MCA) tool5, newly developed for this trial. Follow-up surveys of mentors, who received training, documented statistically significant self-reported skill gains and self-reported changes in mentoring behaviors.6 In addition, interviewed mentees corroborated these positive changes. With this documented success, the most recent research mentor training initiative at UW, funded by a CTSA supplement, has been creation of a web-based Legacy Resource for mentoring development, which has been established to serve national and international mentors and mentees by dissemination of resources, most notably research mentor training curricula (https://mentoringresources.ictr.wisc.edu/). This website provides information on best mentoring practices, as well as access to mentor training curricula, such as Mentor Training for Clinical and Translational Researchers4. The website also offers facilitator training materials, assessment instruments, and centralized data collection for the evaluation of mentoring relationships and mentor training efforts, thus creating a mechanism for ongoing evaluation. Development of the new website consisted of three phases: 1) assembling and testing three new specialized curricula; 2) developing the web- based resources, and 3) integrating the assessment mechanism into the website.

In March 2020, academic medical center (AMC) pharmacies were compelled to implement practice changes in response to the COVID-19 pandemic. These changes were described by survey data collected by the Clinical and Translational Science Awards (CTSA) program which were interpreted by a multi-institutional team of AMC pharmacists and physician investigators. The CTSA program surveyed 60 AMC pharmacy departments. The survey included event timing, impact on pharmacy services, and corrective actions taken. Almost all departments (98.4%) reported at least one disruption. Shortages of personal protective equipment (PPE) were common (91.5%) as were drug shortages (66.0%). To manage drug shortages, drug prioritization protocols were utilized, new drug supply vendors were identified (79.3%), and onsite compounding was initiated. PPE shortages were managed by incorporating the risk mitigation strategies recommended by FDA and others. Research pharmacists supported new clinical research initiatives at most institutions (84.0%), introduced use of virtual site visits, and shipped investigational drugs directly to patients. Some pharmacies formulated novel investigational products for clinical trial use. Those AMC pharmacies within networked health systems assisted partner rural and inner-city hospitals by sourcing commercial and investigational drugs to alleviate local disease outbreaks and shortages in underserved populations. Pharmacy-based vaccination practice was expanded to include a wider range of pediatric and adult vaccines. The COVID-19 pandemic radically altered hospital pharmacy practice. By adopting innovative methods and adapting to regulatory imperatives, pharmacies at CTSA sites played an extremely important role supporting continuity of care and collaborating on critical clinical research initiatives.