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The CTSA Community Engagement Steering Committee (CESC), chaired by Drs. Sergio Aguilar-Gaxiola and J. Lloyd Michener, seeks to engage with communities and clinical practices in the translational research process through bidirectional dialogue with community practitioners and investigators. The CESC also seeks to involve communities so that translational research of the highest quality is informed by community and practice concerns. Results are translated for public use considering practical utility and acceptability to participants, thereby influencing care and, ultimately, improving health. By linking researchers directly with patients, families, community groups, and practitioners, “T2” research has the ability to transform health care and shape the wider community’s view of the value and application of medical research.
Among the CESC’s first major steps is a series of workshops to bring CTSA institutions together to share best practices in engaging and partnering with community providers to translate clinical research into practice. The effort kicks off with an all-day workshop, “Accelerating the Dissemination and Translation of Clinical Research into Practice,” in Bethesda, Md., on May 9th. In planning the workshop, CESC members worked with other consortium representatives and individuals from federal agencies and private organizations, including the Association of American Medical Colleges (AAMC), Agency for Healthcare Research and Quality (AHRQ), Association for Prevention Teaching and Research (APTR), Centers for Disease Control and Prevention (CDC), Health Resources and Services Administration (HRSA), National Institute on Drug Abuse, and NCRR. For more information, including goals and objectives, please visit: http://www.aptrweb.org/workshops.
The national workshop will be followed by a series of five regional workshops, allowing CTSA sites to set general goals and objectives that address T2 research and best practices specific to their geographic and population diversity issues. Recommendations and lessons learned from each workshop will be summarized, integrated, and published in a journal article. The workshops are supported by APTR through a grant from CDC.
A Community-based and Academic Practice Partnership Workgroup (CAPP) will identify existing community-based clinical research programs, beginning with those within NIH. CAPP seeks to leverage existing partnerships and funding to enhance community engagement at CTSA sites.
The CESC also plans to establish a workgroup to identify the core competencies involved in community engagement. This workgroup will work with the Education Steering Committee to blend proposed competencies into a curriculum for researchers.
The CESC is establishing relationships with other agencies and organizations—including CDC, AHRQ, AAMC, APTR, and HRSA—to address community engagement and to pave the way for building partnerships and collaborations on future topics. The CESC is also planning a national face-to-face meeting for September 2008 in Bethesda, Md.
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| Activities of the CTSA Consortium Oversight Committee |
At its January 2008 meeting, the CTSA Consortium Oversight Committee (CCOC) decided to identify principal investigators (PIs) to serve as liaisons to the CTSA steering committees and workgroups. By having PI liaisons, the steering committees and workgroups will have more frequent access to the CCOC through the PIs, enhancing communication. They will no longer have to wait for a webcast presentation or a face-to-face meeting to discuss issues of concern. The following PIs have agreed to serve as liaisons:
Steering Committees
- Community Engagement: Mark Drezner, Elizabeth Ofili
- Education/Career Development: Barry Coller, Robert Sherwin
- Evaluation: Garret FitzGerald, Robert Rizza
- Informatics: Gordon Bernard, Julian Solway
- Public-Private Partnerships: Eric Orwoll, Dan Clauw
- Translational Science: Frank Arnett, Ken Polonsky
Clinical Integration Committee Workgroups
- Administration: Gary Hunninghake, Valerie Montgomery-Rice
- Biostatistics/Epidemiology/Research Design: David Guzick, Milton Packer
- Clinical Research Ethics: Henry Ginsberg, Julianne Imperato-McGinley
- Communications: Mary Disis, David Stephens
- Participant and Clinical Interactions Resources: Steven Reis, Lars Berglund
- Regulatory Knowledge/Clinical Research Management: Daniel Ford, Robert Califf
Oversight Committees
- Pediatrics Oversight Committee: Mike McCune, Pamela Davis
With a view to speeding decision-making, the CCOC established an Operations Committee that will meet every 2–4 weeks by teleconference. Initially, the Operations Committee is focusing on developing a policy for CTSA consortium publications, establishing research subject advocacy at CTSA sites, and optimizing interactions between the CTSA sites and the NIH institutes and centers. The Operations Committee consists of CTSA PI members Robert Califf, Lars Berglund, Gary Hunninghake, Steven Reis, Gordon Bernard, Daniel Ford, and David Guzick and NIH members Franziska Grieder, Barbara Smothers, and Walter Koroshetz. Anthony Hayward and Barbara Alving will serve ex-officio roles.
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| Planning a Workshop: Enhancing Clinical Investigation by Improved Clinical Research Management |
At its January 15, 2008, meeting, the CTSA Consortium Oversight Committee (CCOC) CCOC agreed to conduct a workshop on process metrics. This workshop marks the consortium’s first full-scale effort to plan a large workshop, in collaboration with NCRR, to address a priority identified through the consortium. The workshop evolution and planning process, described below, may serve as a model for future efforts.
During its November 2007 call, the CCOC heard a similar message from two of its workgroups. The Alternative IRB Model Pilots Workgroup, whose goal is to identify circumstances in which alternative IRB models would speed the implementation of clinical research protocols across CTSA sites, determined that the lack of uniformity of the IRB review process poses a significant barrier. A key step forward would be to come to consensus on the use of metrics to measure the individual steps of the IRB process. At the same time, the Regulatory Knowledge Workgroup, which focuses on protecting human subjects and fostering communication among CTSA institutions, saw the need to reduce or remove institutional impediments to clinical and translational research and enhance inter-institutional collaborations.
The CCOC agreed that a standard set of metrics is needed to measure all the steps for clinical research—from protocol initiation through the process of enrollment—with a view to eliminating common roadblocks and improving protocol management. Ultimately, metrics could be used as a tool to improve process management across the whole consortium and within each site.
The CCOC created the CTSA Clinical Research Management Taskforce to conduct a workshop on this topic. The taskforce is under the Regulatory Knowledge Workgroup, with Michael Joyner (Mayo Clinic) and Tesheia Johnson (Yale University) as chairs. Taskforce members represent 16 CTSA sites. The taskforce determined that the goal of the workshop would be to stimulate consortium-wide acceptance of the use of objective measurements of efficiency in protocol processing as a tool for helping CTSA sites identify useful interventions. NCRR is sponsoring the workshop.
The taskforce met weekly until it developed meeting goals, identified a target audience, secured speakers, and agreed upon a format for the meeting. The two-day workshop, to be held June 23–24, 2008, in Bethesda, Md., will include leaders from each CTSA site, representatives from industry, NIH institute program officers responsible for clinical trials, and NCRR staff.
Ideally, the workshop will foster the acceptance of a consortium-wide system of metrics for protocol processing. The workshop will consist of roundtable discussions on IRB processing and contracts processing and a poster presentation by each site on quality improvement. With the participation of senior institutional leadership, the CTSA consortium has an opportunity to lead a national trend toward improved performance.
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| Institutional CTSA Events |
University of Pennsylvania Symposium
The Third International ITMAT Symposium will be April 14–15, 2008. This year’s title is Academia in Drug Discovery and Development.
For more information, please visit http://www.itmat.upenn.edu/symposium.shtml.
University of Pennsylvania Annual Conference on Statistical Issues in Clinical Trials: From Bench to Bedside to Community
The topic of the April 18, 2008, conference is: Early, Translational and Proof-of-Concept Studies: The “Go/No Go” Decisions.
For more information, please visit http://www.cceb.upenn.edu/biostat/conferences/ClinTrials08/.
University of Rochester Symposium: Frontiers in Stem Cell Medicine
The May 23, 2008, symposium will bring physicians, clinical researchers, and basic science researchers together for a day of concentrated interaction.
More information is available at http://www.urmc.rochester.edu/ctsi/includes/StemCellSymposium.cfm.
Please note: We recognize that this is not a complete listing of institutional CTSA events that have open attendance. Please send your CTSA sponsored institutional event to Kameha Kidd, kiddka@mail.nih.gov, for inclusion in newsletters and on the CTSAweb.org Events page.
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New Tool Helps Researchers Find Core Resources at University of California, San Francisco
The University of California, San Francisco’s (UCSF), Clinical and Translational Science Institute launched the Cores Search feature within its web site, which enables searches of more than 90 cores at UCSF. Researchers can search and sort by campus location, resource category, and specific service or equipment. Information about the full range of services available for each core and who to contact for pricing is also accessible.
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| Upcoming Committee Meeting Dates |
Key: CTSA
Consortium Meeting
CTSA
Consortium Workshop NIH
Staff Meeting |
| Sunday |
Monday |
Tuesday |
Wednesday |
Thursday |
Friday |
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1
| CTSA Consortium Meeting |
Pediatrics
Pediatric Research Ethics Consultation Committee
1:00 p.m.–3:00 p.m.
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| CTSA Consortium Meeting |
Biostatistics/
Epidemiology/
Research Design Evaluation Task Force
2:00 p.m.–3:00 p.m.
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2
| CTSA Consortium Meeting |
Communications Operations Committee
11:00 a.m.–12:00 p.m.
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3 |
4
| CTSA Consortium Meeting |
Informatics Directors and Project Group Leads
1:00 p.m.–2:00 p.m.
|
| CTSA Consortium Meeting |
Consortium Oversight Operations Committee
1:00 p.m.–2:00 p.m.
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| 6 |
7
| CTSA Consortium Meeting |
Regulatory and Ethics IRB Taskforce
12:00 p.m.–1:00 p.m.
NIH coordinator
Daniel Rosenblum
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8 |
9 |
10 |
11
| CTSA Consortium Meeting |
Community Engagement Regional Workshops Workgroup
1:00 p.m.–2:00 p.m.
|
| CTSA Consortium Meeting |
Informatics Collaboration and Facilitation Interest Group
4:00 p.m.–5:00 p.m.
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| 13 |
14
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15
| CTSA Consortium Meeting |
Biostatistics/
Epidemiology/
Research Design Online Resources and Education Task Force
1:00 p.m.–2:00 p.m.
|
| CTSA Consortium Meeting |
CTSA Consortium Oversight
1:00 p.m.–2:00 p.m.
Democracy I, Room 987
NIH coordinator
Anthony Hayward
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16
| CTSA Consortium Meeting |
Evaluation
2:30 p.m.–4:00 p.m.
Democracy I, Room 987
NIH coordinator
Lori Mulligan
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17 |
18
| CTSA Consortium Meeting |
Consortium Oversight Operations Committee
1:00 p.m.–2:00 p.m.
|
| CTSA Consortium Meeting |
Education/
Career Development Operations Committee
2:00 p.m.–3:00 p.m.
|
| CTSA Consortium Meeting |
Community Engagement Operations Committee
12:00 p.m.–1:00 p.m.
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| 20 |
21 |
22 |
23
| CTSA Consortium Meeting |
Communications Operations Committee
11:00 a.m.–12:00 p.m.
Democracy I, Room 989
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24
| CTSA Consortium Meeting |
Communications
Communication Systems and Information Management Task Force
3:00 p.m.–4:00 p.m.
|
| CTSA Consortium Meeting |
Community Engagement
Community-Based Academic and Practice Partnership Workgroup
12:00 p.m.–1:00 p.m.
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25
| CTSA Consortium Meeting |
Community Engagement Regional Workshops Workgroup
1:00 p.m.–2:00 p.m.
|
| CTSA Consortium Meeting |
Regulatory Knowledge
2:00 p.m.–3:00 p.m.
Democracy I, Room 1037
NIH coordinator
Jody Sachs
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| CTSA Consortium Meeting |
Informatics Operations Committee
12:00 p.m.–1:00 p.m.
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27
| CTSA Consortium Meeting |
CTSA Consortium Oversight
1:00 p.m.–8:00 p.m.
Chicago
NIH coordinator
Anthony Hayward
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28
| CTSA Consortium Meeting |
CTSA Consortium Oversight
9:00 a.m.–4:00 p.m.
Chicago
NIH coordinator
Anthony Hayward
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29
| CTSA Consortium Meeting |
Biostatistics/
Epidemiology/
Research Design Evaluation Task Force
4:00 p.m.–5:00 p.m.
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30 |
1 |
2
| CTSA Consortium Meeting |
Informatics Directors and Project Group Leads
1:00 p.m.–2:00 p.m.
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* Please note that the meetings and events listed in this newsletter are provided for your information. If you wish to participate, please contact the NIH coordinator.
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CTSAweb.org was developed to ensure access to CTSA resources, enhance communication, and encourage sharing. The site continues to evolve with the CTSA in promoting this new direction of clinical and translational science.
Additional features and updates:
Access archived CTSA e-Newsletters on the CTSAweb.org CTSAs in the News page.
We hope you find this newsletter helpful and informative. If you have any questions, comments, or to remove yourself from this distribution, please contact Kameha Kidd, Office of Science Policy and Public Liaison, NCRR.
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