Yale CTSA Ramps Up Scholar Efforts, Knocks Down Silos

The Yale Center for Clinical Investigation (YCCI)has combined centuries-old tradition with the goal of quickly ramping up trainingfor clinical and translational researchers. The result: an academic pipeline of some 75 individuals headed toward careers in patient-oriented research, with close to a dozen young faculty already receiving independent funding.

Since becoming one of the first 12 institutions to receive a CTSA in 2006, YCCI has also strengthened its core research facilities and organized them for easy access from a single website. On the regulatory front, it has steered clear of silos by collaborating with the Yale Cancer Center (YCC) to provide management for most of the clinical trial functions of both organizations.

“In all these efforts, our goal is to make it easier for researchers to advance the aims of clinical and translational research,” said Robert Sherwin, M.D., YCCI principal investigator. “We are committed to training outstanding researchers, equipping them with the tools they need, and providing an environment that streamlines their work.”

Getting Young Researchers on Their Feet

Since 1839, Yale medical students have been required to conduct research and write a thesis. Many are now focusing on clinical and translational topics. Implementation of the CTSA program at Yale has led to T32 funding for 30 students in medicine, nursing, biomedical engineering, and other graduate programs. In 1999, Yale pioneered one of the country’s first doctoral programs for physicians pursuing clinical research careers; under the CTSA, the Investigative Medicine Program expanded to include scholars in nursing and public health.

In addition, the YCCI/CTSA Scholar program has provided research funding and salary support over the past two years to 29 junior faculty and senior fellows pursuing careers in clinical or translational research. This diverse group, representing more than a dozen disciplines, has gone on to attract close to $17 million in independent funding, including two R awards and nine K awards.

Partnering with the Cancer Center

By focusing on common ground and not trying to integrate every function, YCCI and YCC have been able to combine and share resources extensively. This collaboration has set the stage for tackling even bigger challenges, such as the selection and implementation of electronic clinical trial management and data capture systems.

The two units recently merged several aspects of the management structure for clinical trials, combining such functions as budgeting, contract negotiations, billing, protocol development, and investigational new drug applications. Scientific review remains separate, but support staff will be shared, and YCCI and YCC are streamlining the approval process. As a result, not only will scientific review be more cost-effective, but the workload of faculty reviewers will be reduced, which should encourage more faculty participation in the review/regulatory process.

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KFC Drafts Core Competencies for Clinical and Translational Science

NCRR, in collaboration with the CTSA Education and Career Development Key Function Committee, formed the Education Core Competency Work Group to define the training standards for core competencies in clinical and translational research. The overall goal is to create competency-based educational curricula for training clinician-scientists that will define the discipline of clinical and translational science.

Articulating the core competencies began with a workshop hosted by NCRR in January 2008. Initially, the work group planned to draft competencies for master’s and doctoral candidates, but it was advised that the two degree offerings must be unique and distinct to ensure the most applicable curricula. Therefore, the current focus has been on defining the basic knowledge, skills, and attributes that a master’s-level candidate should attain.

The final recommendations for the core competencies address the following themes:

• Identification of major clinical/public health problems and relevant research questions
• Ability to critique published literature regarding a health problem
• Design of a study protocol for clinical and translational research
• Study methods, design, and implementation
• Laboratory, clinical, and population research methods
• Sources of error and data quality
• Statistical methods and analysis
• Biomedical informatics
• Clinical research ethics
• Conduct of responsible research
• Scientific communication skills and dissemination
• Population diversity and cultural competency
• Translational teamwork
• Leadership and professionalism
• Cross-disciplinary training and mentoring
• Community engagement in clinical and translational research

The work group members presented the draft core competency recommendations to the Strategic Goal Committee on Training and Career Development of Clinical/Translational Scientists in late May. In early June, the CTSA Consortium Steering Committee reviewed and endorsed the competencies.

The Strategic Goal Committee will now begin the challenging process of aligning the competencies with curricula in programs across the CTSA consortium. Some competencies will be assessed traditionally — for instance, by comprehensive examinations. Others will be assessed through thesis defense or other means. Some institutions have already begun mapping the competencies to their curricula. The draft competencies are available on the CTSA wiki.

Major Improvements to CTSA Consortium Website and Wiki

Improvements to both the CTSA consortium’s public website (CTSAweb.org) and the password-protected CTSA Wiki are now in place, offering easier access to information and other features.

The new CTSAweb.org home page, in keeping with the website’s role of ensuring access to CTSA resources, enhancing communication, and encouraging sharing, now features:

• Streamlined navigation menus organized around specific audience needs
• Links to strategic goal committee (SGC) and key function committee (KFC) “landing” pages
• New regional consortia pages
• Highlight boxes for consortium strategic goals, featured institutions, and regional consortia activities
• A refocused communication toolkit tailored to the needs of consortium members, which includes a CTSA slide set, logo, and banner
• A new media resource page for reporters and editors and more.

The CTSA Wiki now offers a host of upgrades and functional improvements intended to make it more useful to consortium members, such as:

• A dynamically updated, centralized calendar that includes meeting call-in information and a means of copying meetings directly to Microsoft Outlook calendars
• Multimedia training modules to help you get the most out of the CTSA Wiki
• Reorganized SGC and KFC landing pages—new, more prominent headers and reorganized content improve readability and provide easier access to common information.
• Committee rosters that are dynamically updated and include member roles and e-mail addresses
• Past meeting materials—each committee has a dedicated page that is dynamically updated with its meeting agendas, summaries, and past presentations.

These upgrades to the consortium website and Wiki build upon other improvements, such as federated access for the consortium Wiki, initiated by NCRR to meet the needs of the consortium members. To provide feedback on either CTSAweb.org or the CTSA consortium Wiki, please contact help@ctsaweb.org.

University of Iowa Hosts Fourth Annual Upper Midwest Consortium Meeting

The University of Iowa Institute for Clinical and Translational Science (ICTS) hosted faculty, scholars, and training program leaders from regional institutions involved in clinical and translational science during the Fourth Annual Upper Midwest Consortium (UMC) meeting on June 8–9.

The meeting provided an opportunity to identify areas of potential scientific collaboration and sharing of research and mentoring resources across institutions, according to Gary Hunninghake, M.D., UI professor of internal medicine and director of the ICTS.

Meeting participants represented the Midwest’s leading clinical and translational science organizations, Hunninghake said.  Membership in the UMC spans a large range of institutions, including CTSA consortium members as well as NIH Institutional Development Award (IDeA) program participants. Attendees at the June meeting included CTSA members: University of Chicago, University of Iowa, University of Wisconsin, and the Mayo Clinic; and IDeA members: University of Kansas, University of North Dakota, University of South Dakota, and the University of Nebraska Medical Center. Other academic medical center attendees included the University of Minnesota.

A steering committee was formed to ensure continued development of the consortium and to provide oversight for future conferences.  The 2010 conference will be co-hosted by the University of Nebraska Medical Center and the University of Kansas.  It will be held in early June.  At that time, the consortium will debut its new name, “Midwest Consortium,” which defines the group better than the previous upper Midwest descriptor.

Selected presentations from the conference were webcast live, including the keynote address by Geoff McLennan, M.B., Ph.D., UI professor of internal medicine, radiology, and biomedical engineering and director of the Translational Lung Imaging Research Program, who spoke on “Personalized Medicine through Multi-Scale Pulmonary Imaging.”

Archived videos of the presentations, scholar talks, workshops, and evaluations