CTSA Program Update
December 14, 2018
HELP US RENAME THE CTSA PROGRAM UPDATE!
CLIC and NCATS are working together to revamp and modernize the monthly CTSA Program Update. This includes a brand new title for the newsletter – and we want your help in naming it! We will be accepting submissions until December 31, 2018. The winning name, to be selected by Dr. Michael Kurilla, will be revealed in the new and improved January update on January 11, 2019. Click here for more information and to submit your winning idea.
NIH HEALSM PAIN EFFECTIVENESS RESEARCH NETWORK: CLINICAL TRIAL PLANNING AND IMPLEMENTATION COOPERATIVE AGREEMENT (UG3/UH3)
The purpose of RFA-NS-19-021 is to solicit cooperative agreement applications that propose clinical trials to establish the comparative effectiveness of existing therapies or effectiveness of existing or novel approaches for prevention and management of pain while reducing risk of addiction. The studies must address questions within the mission and research interests of participating NIH Institutes and Centers and evaluate strategies or interventions to prevent and/or manage specific pain conditions, including medications, biologics, procedures, medical and assistive devices and technologies, behavioral change, rehabilitation strategies, complementary therapies, integrated approaches, and delivery system strategies, through well-controlled trials.
NCATS is interested in supporting research that establishes methods to translate efficacious non-opioid interventions for management of acute or chronic pain conditions into effective therapies that can be delivered successfully in rural settings.
Awardees will be required to conduct their studies through the NIH HEAL Pain Effectiveness Research Network (NIH HEAL Pain ERN), which will have dedicated pain and clinical trial design expertise. The NIH HEAL Pain ERN will use the infrastructure of the NCATS Trial Innovation Network (TIN) to provide scientific guidance and coordination of the NIH HEAL Pain ERN trials. The TIN will work with the broad consortium of CTSA Program hubs and other sites identified by awardees to implement studies. The TIN investigators will work with UG3/UH3 awardees during the planning and implementation phases, and will provide clinical coordination center (CCC) services, data coordination center (DCC) services, recruitment and retention services, and biostatistical support.
See RFA-NS-19-021 for the complete funding opportunity announcement and visit the Trial Innovation Network website for a list of CTSA Program hub resources.
For additional information please email Jane C. Atkinson, DDS at jatkinso@mail.nih.gov.
PRIOR APPROVAL OF NEW STUDIES WITH HUMAN SUBJECTS
Prior Approval requests for new studies that involve human subjects research must be submitted to NCATS via the new eRA Human Subjects System beginning Jan. 1, 2019. For more details please refer to the email notification sent this week or contact your Program Official.
2019 SPRING CTSA PROGRAM GROUP MEETINGS
Additional details regarding meeting dates and times for the 2019 Spring CTSA Program Group Meetings, taking place March 4 and 5 in Washington, D.C., are now available on the CLIC website.
CTSA PROGRAM WEBINARS
The next CTSA Program Webinar will take place on January 23. As a reminder, the December 26 Webinar has been cancelled. For more information, visit the CLIC site.
ADMINISTRATORS GROUP
The next CTSA Program Administrators quarterly webinar/call is scheduled for December 19 from 1:00 – 2:00 p.m. ET. These meetings are open to CTSA Program Hub administrators only. If you have not yet registered as one of the two hub administrators, please email administrators_group@clic-ctsa.org to be added.
CLIC UPDATES
UF UN-MEETING ON RURAL HEALTH & HEALTH EQUITY
The University of Florida (UF) Clinical and Translational Science Institute (CTSI), in collaboration with the UF Institute of Food and Agricultural Sciences (IFAS), has been selected as this year’s recipients of CLIC funds and support to host a national Un-Meeting. This event, taking place on April 8 in Gainesville, Florida, will focus on catalyzing new collaborations to bridge the translational science and agricultural extension sectors to improve rural health and health equity.
Look for more details in early 2019! In the meantime, read more here.
UPDATED CLIC WEBSITE
CLIC is excited to announce that we’ve made some changes and updates to our website. We encourage CTSA Program members to explore the site, share feedback and reach out with any questions.
COMMON METRICS UPDATES
COMMON METRICS SESSION: SPRING CTSA PROGRAM MEETING
A Common Metrics session will occur on Tuesday, March 5, 2019 from 8:30 a.m. – 12:00 p.m. as a part of the 2019 Spring CTSA Program Group Meetings. Hub Principal Investigators, Administrators and Evaluators are invited to attend. Session details will be forthcoming.
OPPORTUNITY TO EXCHANGE IDEAS
We have an online community established for Common Metrics on the CLIC Forum: Common Metrics. This is a place for you to ask questions, discuss best practices and/or strategies, and idea share. Log on to the website to participate in previous conversations or start new ones. You can view any of the current threads (thank you to those who have already contributed!).
CM IMPLEMENTATION PROGRAM AND EVALUATION STUDY
The final report from the Tufts University CTSI on the Common Metrics Implementation Program and Evaluation Study is available here.
2016 COMMON METRICS HUB REPORT FEEDBACK RESULTS
Subsequent to the release of the 2016 Common Metrics Hub Reports, the CLIC developed and sent a survey to each of the hubs. The survey was designed to solicit feedback regarding the usefulness of each of the report sections and to obtain suggestions for improving future reports. A summary report of the survey results is now available on the CLIC website.
INFORMATICS COMMON METRIC UPDATE
Phase 2 of the Informatics Metric implementation will begin in January 2019. For implementation and reporting information click here. All hubs are expected to participate in this phase. Metric operational guidelines (OG), Informatics Common Metrics team formation tool, and an overview of informatics are all available on our Common Metrics webpage.
Please do not hesitate to contact us if you have questions regarding your Informatics Metric implementation – common_metrics@clic-ctsa.org.
DOMAIN TASK FORCE (DTF) UPDATES
DTF Workgroup Guidance
CTSA Program Leadership has provided clarification regarding DTF activities while the Steering Committee DTF Task Force continues to consider modifications to the current DTF system:
- DTF Elections may take place.
- Work Groups
- Existing: Continue; you are encouraged to scale remaining activities/objectives for completion by Dec. 2019.
- New
- Three new iDTF Work Groups were presented at the Fall Steering Committee meeting and have completed charters. These three may proceed with the understanding that the activities/objective(s) will be scaled for completion by Dec. 2019.
- Other DTFs considering new Work Groups
- DTFs are encouraged to focus on one or two new, targeted areas over the next 12 months.
- New Work Groups may be proposed to the Steering Committee; request must include:
- Specific Objective/Challenge to be addressed
- Broader context/goal
- Timeline w/ Milestones (completion by Dec. 2019)
- Output/Deliverable
COLLABORATION & ENGAGEMENT DTF
The Collaboration & Engagement DTF Lead Team election has been completed – three new members have been voted to the Lead Team. Linda Ko is the co-director of the community engagement program at the Institute of Translational Health Sciences at the University of Washington, Elizabeth Miller is the co-director for community engagement for University of Pittsburgh Clinical and Translational Science Institute, and Laurene Tumiel-Berhalter is the community engagement core director for the University at Buffalo’s Clinical and Translational Science Institute. We welcome them to the Lead Team!
Save the Date! The Collaboration & Engagement DTF Face-to-Face Meeting will be held on Tuesday, March 5, 2019 in Washington D.C. Additional details will be shared as they become available.
INFORMATICS DTF
Save the Date! The Informatics DTF (iDTF) Face-to-Face Meeting will take place on Friday March 29, 2019 in San Francisco from 7 a.m. – 1 p.m. PT. Let us know what else you’d like to discuss via the REDCap survey sent out on Monday, November 5 or email via informatics_dtf@clic-ctsa.org.
New Work Groups
Three new iDTF Work Group charters have been approved by the CTSA Program Steering Committee effective December 5, 2018.
- Enterprise Data Warehouse
- Sustainability Phase Two
- Text Analytics and De-Identification
The Work Group leads are working to determine meeting days and times to get started in January. Stay tuned! Interested in joining? Contact informatics_dtf@clic-ctsa.org and your request will be sent to the appropriate leads.
Publishing Update
We are very pleased to announce that the Sustainability Informatics Infrastructure Work Group has successfully published their paper from phase one of the Sustainability Work Group: Sustainability Considerations for Clinical and Translational Research Informatics Infrastructure (can also be accessed on the CLIC website via the iDTF page).
Authors:
Obeid, J., Tarczy-Hornoch, P., Harris, P., Barnett, W., Anderson, N., Embi, P., . . . Wehbe, F. (n.d.). Sustainability considerations for clinical and translational research informatics infrastructure. Journal of Clinical and Translational Science, 1-9. doi:10.1017/cts.2018.332