10.12.18 CTSA PROGRAM UPDATE
Note: Based on feedback from the consortium, we are working to streamline and shorten the CTSA Program Update as much as possible. One of the changes we’ve made is to include a ‘clickable’ Table of Contents, allowing readers to easily navigate through the content and jump to various sections of the newsletter. If you have any trouble with this feature, please select the option to ‘View this email in your browser.’
TABLE OF CONTENTS
- CTSA Program Updates
- CLIC Updates
- Common Metrics Updates
- Domain Task Force (DTF) Updates
- Updates from Other CTSA Program Initiatives
- Announcements & Opportunities
- Meetings & Events
CTSA PROGRAM UPDATES
RE-ISSUE OF CTSA PROGRAM FUNDING OPPORTUNITY
NCATS has announced a new Clinical and Translational Science Awards (CTSA) Programfunding opportunity to support cutting-edge clinical and translational science advances. The first application due date is Jan. 25, 2019. Letters of intent are due 30 days prior to the application due date. Applicants are encouraged to apply early.
Click here to share this opportunity on Twitter.
AAMC WEBINAR SERIES: THE LATEST DEVELOPMENTS FROM THE CTSA PROGRAM
This series of webinars presents key initiatives happening at CTSA Program hub sites, upcoming funding opportunities available through NCATS, and resources for fostering innovation and cutting-edge translational research activities.
The next webinar will take place on Tuesday, October 30, 2018 from 2:00 – 3:00 p.m. ET and will cover ‘Collaborations across NCATS’s Trial Innovation Network.’
Click here to register for this webinar.
FALL CTSA PROGRAM MEETING
Registration for the 2018 Fall CTSA Program Meeting, taking place October 22-23, is still available! CLICK HERE TO REGISTER. Please note: the Full Day Fall CTSA Program Meeting is October 23 only.
Networking & Poster Session Registration
The Fall CTSA Program Meeting will kick off with a Networking & Poster Session where each hub will have the opportunity to showcase 1-2 innovative hub projects or ideas while networking with program colleagues. The poster registration for this even is now closed. Please contact your CTSA Program Official with any questions.
Great CTSA Team Science Contest
We received 170 outstanding stories about team science via the Great CTSA Team Science Contest! The committee is working through the reviews to identify the winners, which will be announced at the Networking & Poster Session at the Fall CTSA Program Meeting on October 22.
Administrators Face-to-Face Meeting
The registration for the CTSA Program Administrators’ Face-to-Face Meeting, taking place October 22 prior to the 2018 CTSA Program Fall Meeting, is still open! CLICK HERE TO REGISTER. Full details and a draft agenda from NCATS/CLIC can be found on the CLIC site.
CTSA PROGRAM PI MONTHLY WEBINARS
Reminder: the October 24 and December 26 PI Webinars have been cancelled. For more information, visit the CLIC site.
FUNDED ADMINISTRATIVE SUPPLEMENTS FOR THE NCATS CTSA PROGRAM IN RESPONSE TO NOT-TR-18-022
Thank you for the tremendous response to this solicitation! The list of funded administrative supplements responsive to NOT-TR-18-022 is now posted on our website here. We look forward to disseminating the outcomes of these projects in future communications.
FUNDED ACTIVITIES UNDER THE NCATS CTSA PROGRAM UPDATED WITH FY18 INFORMATION
The updated “Funded Activities Under the NCATS CTSA Program” table has been posted on the NCATS website here. This link can be found on multiple NCATS web pages, including the homepage.
CLIC FORUM NOW LIVE!
After months of hard work, CLIC is excited to announce that the CLIC Forum is now live! Program members can use the forum to ask the consortium questions, discuss best practices, bounce ideas off each other and share opportunities. We encourage you to explore the platform, begin sharing ideas and thoughts, and reach out to us with any questions. Please note that you must be logged into the CLIC website to access the forum’s functionality. Visit the CLIC Forum today!
APPROACHING DEADLINES: COLLABORATIVE FUNDING OPPORTUNITIES
As a reminder, the application deadlines for the Un-Meeting and Synergy Paper RFAs are quickly approaching.
- Un-Meeting RFA Deadline: October 15, 2018
- Synergy Paper RFA* Deadline: November 5, 2018
Synergy Papers: The goal of cross-hub multi-disciplinary translational science “synergy” papers is to advance the field of translational science and build collaborations within and external to the CTSA Program consortium, while meeting the academic needs of co-authors to produce high quality scientific publications.
Un-Meetings: These attendee-driven events without the rules and structure of a traditional conference provide a unique space for discussion of experiences and to identify areas of potential research, innovation, and collaboration, with the ultimate goal of developing multidisciplinary, collaborative partnerships.
More information and all application requirements can be found on CLIC’s website:
*If you are interested in participating on the Synergy Paper application review committee, please email firstname.lastname@example.org for more information.
COMMON METRICS UPDATES
COMMON METRICS SESSION AT THE PROGRAM MEETING
A 45-minute session will be devoted to the Common Metrics Initiative and the 2016 report on October 23 at 7:30 a.m. The Common Metrics team wants to maximize the opportunity with PIs and administrators to ask questions about the Hub-specific reports and other related questions. Please join us!
COMMON METRICS REPORT FEEDBACK
A huge thank you to all who responded to the hub report feedback survey. We had a 94% response rate! We appreciate your time and effort in providing this invaluable feedback. Responses and comments will be used to inform the next Common Metrics analysis and report.
Some initial feedback and insights on the reports can be viewed in this blog post: Illustrating the potential impact of the CTSA Program: a closer look at the Common Metrics Initiative.
THE INFORMATICS COMMON METRIC
Several webinars and office hours have been held supporting the implementation of the Informatics metric. Topics have included: selecting data models, running scripts, using the Clear Impact Scorecard and reviewing the Results-Based Accountability framework. All webinars and office hours are recorded and available via a Google Drive collaborative space, which metric hub contacts have received. For more information on this metric visit Common Metrics or contact the Common Metrics team with questions!
DOMAIN TASK FORCE (DTF) UPDATES
COLLABORATION & ENGAGEMENT DTF
Elections for the Collaboration & Engagement DTF Lead Team will occur in November, so please think about nominating someone or self-nominating (there are three open slots). Additional details regarding the election process will be sent via email. Louisa Stark has accepted the Lead Team’s nomination as the elected co-chair for next year; Sergio Aguilar-Gaxiola, Syed Ahmed and Tabia Henry Akintobi will rotate off the Lead Team. Thank you Sergio, Syed and Tabia for your years of service!
METHODS & PROCESSES DTF
The second annual Regulatory Science to Advance Precision Medicine Forum took place on Thursday, 27 September 2018 at the PhRMA foundation in Washington, D.C., bringing together participants from academia, industry, government agencies, foundations and scientific organizations. With leadership from the University of Rochester CTSI and planning by the Regulatory Science to Advance Precision Medicine Working Group (under the Methods and Processes DTF), the working group selected the topic of Digital Health for the 2018 Forum. Morning talks by Dr. Rob Califf (Duke) and leading experts from Sage Bionetworks, the NIH All of Us Initiative and the FDA set the stage by outlining the emerging science and regulatory considerations for digital health technologies and approaches. Breakout sessions then explored specific opportunities and challenges related to the user interface of mobile health and to data standards and analytic needs.
UPDATES FROM OTHER CTSA PROGRAM INITIATIVES
ACCRUAL TO CLINICAL TRIALS (ACT) NETWORK
The ACT Network welcomes nine additional institutions to the ACT production network: UAB, Wash. U St. Louis, Boston U., UAMS, UTHSCSA, Johns Hopkins, UNC, Univ. of Kentucky and NYU. Their data is now ‘queriable’ across the network. By early 2019, the ACT Network will encompass approximately 80% of the CTSA Program consortium, and will include data from an estimated 100M patient records!
In addition, beginning October 9, the ACT production network will take the newest version of the SHRINE software. This version offers a great benefit to end users, as it allows for asynchronous query responses. Following the upgrade, investigators will receive patient counts from each institution as soon as they are available.
Questions? Contact Elaina Sendro
TRIAL INNOVATION NETWORK (TIN)
The TIN has received 144 proposal submissions from 54 CTSA Program hubs. Ready to submit your proposal? Learn more about the proposal submission process here. For the latest updates from the TIN, sign up for our monthly newsletter.
NEW Recruitment and Retention Resources Now Available
- Online Resource for Recruitment Research in Clinical Trials (ORRCA). The ORRCA project (Online Resource for Recruitment research in Clinical triAls) aims to bring together published and ongoing work in the field of recruitment research into a searchable database.
- Patient Advisor Toolkit 1: Orientation for Patient Advisory Committees, University of Wisconsin- Madison. The Patient Advisory Toolkit-1 is a comprehensive set of modifiable resources for conducting an orientation with patient advisors. The toolkit provides a complete, step-by-step guide to preparing patient advisors to work effectively with researchers.
Find these resources and more here.
- Biobanking, Genomic Research – Medicine’s Brave New World: Understanding and Acceptance of Individuals Underrepresented in Clinical Trials
- October 17, 2018, 12:00 p.m. ET
- EHR-Based Cohort Discovery: A Continuum from Informatics Tools to First Contact of Participants to Enhance Local Recruitment Strategies
- October 18, 2018. 2:00 p.m. ET
- DSMB operations: Nuggets for investigator-initiated clinical research
- November 14, 2018, 12:00 p.m. ET
Questions? Contact Terri Edwards
RECRUITMENT INNOVATION CENTER (RIC)
Spotlight on RIC Tools and Services: Community Engagement Studio
Community Engagement Studios (CE Studio) are consultative sessions for researchers to get input on their project from key stakeholders, such as patients, caregivers and providers. A panel consisting of the researcher’s population of interest provides feedback to enhance the planning, design, implementation, translation, or dissemination of the research.
The RIC CE Studio Team conducted a demo at NCATS day on Sept. 28, 2018. The CE Studio was lived streamed to the main meeting room for NCATS Day attendees and online.
The Community Engagement Studio is offered as a core service by the Recruitment Innovation Center. You can learn more about community engagement and the CE Studio model process by accessing the RIC Recruitment and Retention Toolkit or the Vanderbilt Institute for Clinical and Translational Science Community Engagement Toolkit.
Questions? Contact Mary Stroud
IRB RELIANCE EXCHANGE (IREx)
IREx Makes Institutional Profiles Publically Available
On October 1, 2018, the IREx members made their Institutional Profile (IP) publicly available as a date-stamped PDF on the IREx Members page (http://IRBExchange.org/p/participants), establishing the first national database of standard, institution-level data. This functionality fosters transparency and high-quality information sharing among HRPPs and IRBs, which is believed to facilitate and streamline the single IRB process. The value of the IP is projected to grow exponentially as IREx expands. IREx currently supports over 200 Institutions (95% of CTSA Program hubs), 80 studies, 1500 users, and nearly 700 reliances. To date, over 90% of IREx Institutions have documented reliance for at least one study using the portal.
The IREx IP captures four types of information, as seen in the graphic below.
NATIONAL CENTER FOR DATA TO HEALTH (CD2H)
New CTSA Program PI Focus Group to Provide Insights and Guidance for CD2H
CD2H is committed to widespread CTSA Program engagement in order to build concrete solutions that address meaningful pain points for hubs. To achieve these objectives, we’ve recently formed a CTSA Program PI focus group comprising a broad spectrum of leaders from across the country. The group’s role is to help us determine key needs and to help guide our initiatives. Learn more and see the list of focus group members here. We thank them for their willingness to participate and look forward to our first in-person meeting later this month at the CTSA Program Fall Meeting.
Great Turnout, Input at First Community Workgroup Meetings
We are thrilled with the turnout and engagement at the first quarterly meetings of the CD2H Data and Software Community Workgroups held in September. More than 95 people joined the Data Workgroup meeting and more than 80 participated in the Software Workgroup meeting. At both meetings, participants contributed valuable insights and ideas to shape future plans for these Workgroups. We’ve compiled notes from the meetings’ brainstorming sessions and are working through them now. You can view these community brainstorming notes and the slides and recordings from these meetings by visiting our blog.
Register Now for October/November Events
- Register for the People, Expertise and Attribution Community Workgroup interactive web meeting on October 18 at 9 a.m. PT / 12 p.m. ET.
- Attend the “Opportunities for CTSA Program Hub Engagement with CD2H” presentation at the CTSA Program Fall Meeting, Oct. 23 in Arlington, V.A.
- Register for the People, Expertise, and Attribution Community Workgroup Show and Tell on November 2 at 10 a.m. PT / 1 p.m. ET
Stay Current, Subscribe to the CD2H Newsletter
Have you signed up yet for the CD2H Newsletter? It’s your best way to stay up to date on the latest news and developments from the CD2H as we work to support and accelerate collaboration and innovation across the CTSA Program informatics ecosystem. Subscribe here and also be sure to follow us on Twitter at @data2health.
Questions? Contact Sarah Biber
NATIONAL PROGRAM EVALUATORS GROUP
The CTSA Program Evaluation Survey Workgroup has completed the data compilation of 61 received responses and has begun analysis of the data for the overall responses, size category groupings and hub age groupings. The Evaluation Guidelines Work Group has completed analysis of the narrative responses regarding the evaluation challenges and examples of evaluation impact responses as well as the responses to questions on evaluation resources and tools at CTSA hubs. The Evaluator Survey Work Group is completing the analysis of narrative responses regarding evaluation accomplishments and challenges. CLIC is analyzing the responses to the question regarding the impact the Common Metrics Initiative has had on local hub programs and evaluation practices. The National Program Evaluators Group committee will meet to review preliminary results first, then share widely with the full group. The Evaluator Survey Working Group is on schedule to complete the first report in the fall of 2018.
The CTSA Program Evaluation Guidelines Workgroup has completed a qualitative analysis of an item on the 2018 CTSA Program Evaluators Survey. The item asked for evaluators’ suggestions for strengthening CSTA Program evaluation so that it appropriately informs research policy and justifies resource allocations with Congress and the public. The workgroup has developed a summary of key messages from evaluators. The summary will be included in a forthcoming white paper and discussed at the upcoming meeting of the American Evaluation Association at the end of October.
ANNOUNCEMENTS & OPPORTUNITIES
A full list of NCATS announcements and opportunities can be found here:https://ncats.nih.gov/funding/open.
NCATS RARE DISEASES ARE NOT RARE! CHALLENGE PRIZE DETAILS
NCATS is seeking innovative ways to communicate with others to educate people about rare diseases through social media or art. The goal of this Challenge (link is external), which is being led by NCATS’ Office of Rare Diseases Research, is threefold: First and foremost, it is to raise awareness for all rare diseases in a collective manner. Second, it is intended to bring attention to the many people with rare diseases; and finally, it is to highlight the need for research and the development of new treatments. You can help us get the word out by competing in our rare diseases prize competition! Entries must be submitted to Challenge.gov by Noon Eastern time on October 28, 2018.
For more information please follow: Rare Disease Challenge
NIDA ISSUES FOAs ON HEALING COMMUNITIES STUDY
On September 19, 2018, NIDA issued two funding opportunities for cooperative agreements to support components of the HEALing Communities Study – an integrated approach to test interventions for opioid misuse and addiction in communities hit hard by the opioid crisis.
For more information on the funding opportunities, go to:
- HEALing Communities Study: Developing and Testing an Integrated Approach to Address the Opioid Crisis (Data Coordinating Center) (Clinical Trials Not Allowed)
- HEALing Communities Study: Developing and Testing an Integrated Approach to Address the Opioid Crisis (Research Sites) (Clinical Trial Required)
MEETINGS & EVENTS
UPCOMING CONSORTIUM EVENTS
CTSA Program hubs can find information about meetings, events, conferences, and/or items relevant to the CTSA Program and the advancement of translational science on the events page on the CLIC website. If you would like to showcase an event, please fill out the event form (login required) on the CLIC website.
Once you host an event, if you would like your presentations uploaded for viewing on the archived CLIC events page, please submit a PDF version of your event presentations to the email below.
Questions? Contact email@example.com
UPCOMING NCATS MEETINGS
|Second Monday of the month;
2:30 – 4 PM ET
|CTSA Program Steering Committee Meeting Executive Session||CLIC Steering Committee Meetings Page*|
|Fourth Wednesday of the month;
2 – 3 PM ET
|CTSA Program PI Monthly Webinar||Webinar Registration**
Please note that the October 24 and December 26 CTSA Program PI Webinars have been cancelled.
*CLIC will post meeting summaries from the S/C calls onto the CLIC-CTSA Program websiteand continue to circulate monthly CTSA Program newsletters with important project-level updates and consortium activities.
**To add the PI Webinar to your calendar: Please make sure that once you submit the completed registration form, choose “add to calendar” on the Registration Approval page OR in the Confirmation email that you receive, then open and save the downloaded calendar file.