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CTSA Program Webinar
Wednesday, August 28, 2019
2:00 PM – 3:00 PM ET
Agenda
2
Time Topic Presenter
2:00 PM -
2:05 PM
Welcome
NCATS and CTSA Program UpdatesClare Schmitt, PhD
2:05 PM -
2:25 PM
Informatics Common Metrics
Implementation and Data Report
Ken Gersing, MD
Ann Schwartz, MPH
2:25 PM -
2:45 PM
CTSA Program Collaborative Innovation
Awards (CCIA)H. Timothy Hsiao, PhD
2:45 PM –
3:00 PMCLIC Updates Deborah J. Ossip, PhD
3:00 PM Adjourn
NCATS and CTSA Program Updates
Clare Schmitt
Transition to Enterprise Committees
• Transition is in full swing
• Domain Task Force Summary Report
• SC reviewed
• 3 requests for WG extensions of 6-12 months
• Informatics: 2; Methods & Processes: 1
• SC decision: all 3 should submit a request for a new WG and/or transition
to a Discussion Forum in Jan 2020
• WG Application: Submissions Oct. 1-31 (revised dates)
4
CTSA Program Competitive Revision (Supplement) Solicitation
• PAR-19-337
• Eligibility: Awardees with active CTSA Program hub awards (UL1). Only
applications for revisions to the UL1 award are allowed. Revisions to the
linked KL2 and/or the TL1 awards are not allowed.
• Purpose: Support the demonstration, dissemination, and/or
implementation of highly innovative and impactful translational science
projects that address the goals of the CTSA Program and are beyond the
original scope of the approved parent project
• Earliest Submission Date: August 25, 2019
• Due Dates: September 25, 2019; September 25, 2020; September 27, 2021
CTSA Program Feedback
Soliciting input on process (RFA issues) and program objectives
• Peer Reviewers
• Public & Consortium members• Request for Information (RFI; mid-Sept thru late Oct 2019)
• Town Hall Q&A January 2020 (tentative)
• NCATS
6
Informatics CM Implementation and Data ReportKen Gersing
Ann Schwartz
Informatics Common Metrics Implementation and Data ReportThe complete report is available on the Hub Report page of the CLIC website – log in is required
Informatics Vision the CTSA Program
Vision:
The CTSA Program is a collaborative and interoperable national research network
that will leverage resources across multiple systems and unique expertise within our
institutions to connect research to health care that results in better health through
research
Goals for the Informatics Common Metric
• Meaningful and useful activity for both local hubs and CTSA Program
• Low cost/burden of implementation – Scripts are prebuilt for community
• Align with other CTSA Program initiatives i.e. TIN, ACT, CD2H
• Facilitate the interoperability of research data through the use of standard value
sets i.e. ONC, HL7, CDISC, NCI EVS, NLM etc.
• Facilitate sharing of research data across common data models i.e. PCORI,
ACT/i2b2, Sentinel, and OMOP (FAIR Data Principles)
• Facilitate Translational Science across the research spectrum, preclinic to clinical
Goals for Informatics Implementation• Establish a set of baseline characteristics at each CTSA’s Research
Data Warehouse (RDW)
• Encourage hubs to record data using standard value/code sets• ICD, RxNorm, LOINC, etc.
• Standardize Research Data Warehouses (RDWs) to increase interoperability for investigators across the consortium
Over time, this metric will evolve into a comprehensive characterization of RDWs, as well as a quality improvement tool
Results
136,333,783 Unique Patients in 58 Hubs
Patient Count by Data Domain
Data Domain and Data Model by Hub
NMR = No Model ReportedOther = Not OMOP, PCORnet, i2b2/Act, TriNetX or reported multiple data models
Observations Present by Data Model
i2b2/ACT
26%
OMOP
15%
PCORNet
14%
TriNetX
7%
Other
21%
NMR
10%
Missing
7%
“Other” and “NMR”
• Scorecard functionality did not enable hubs to use a drop-down menu for data model
• Multiple data models were entered
• Data source rather than data model was entered
• Name variations in data models
See Appendix 8 for details regarding data
Variations in Data Reporting
• Data entry
• Scorecard functionality
• Hub data/data model• Request for Approval for Alternate Informatics Data Model
Next Steps
Informatics Common Metric: Year 2
• This metric was designed to evolve over time to enhance the completeness of the data repositories across the CTSA Program consortium and incorporate additional types of data with repositories as the CTSA Program, in collaboration with the iDTF, finds useful and appropriate.
• Hubs were encouraged to test the collection of additional data domains to inform the iDTF discussions about the evolution of the metric (and send info to CLIC https://clic-ctsa.org/common_metrics/help-desk)
Informatics Common Metric: Year 2
• Step 1: CLIC/NCATS review feedback from Year 1 and consult with iDTF members:
• Potential additional data domains:
• Vitals (height, weight, temperature, respiratory rate, pulse, diastolic and systolic)
• Visits with procedures (% of visits with procedure code)
• Others?
• Incorporate a timeframe for data capture
• 1 year and 5 year
• Step 2: Work with “Quality Improvement Committee”:• To add to the scripts and test the scripts:
• Data model experts
• Script developers
• Testers of the new scripts
Timeline: Year 2
• Fall 2019:• Review new enhancements and consult with iDTF
• Quality Improvement Committee to modify scripts and test
• Present and get feedback to enhancements:
• CTSA Program Common Metrics Initiative Executive Committee
• CTSA Program Steering Committee (get feedback, test any updates on scripts)
• Winter/Spring 2020• Release enhanced scripts and Operational Guidelines
• Common Metrics Reporting for 2019 data:• Due August 31, 2020
Q&A
CTSA Program Collaborative Innovation Awards (CCIA)H. Timothy Hsiao
25
Goal of this Presentation
• To provide updates and review of the CCIA portfolio
• To promote collaborations through the CCIA mechanisms to accomplish the CTSA Program goals
Expected Outcomes• New collaborations
The CTSA Program Collaborative Innovation Award (CCIA):
Updates & Portfolio Review
H. Timothy Hsiao
August 28, 2019
CCIA Program Structure
U01
≥3 CTSA Program hubs;
or, ≥2 CTSA Programs hubs + ≥1 IDeA-CTR
PAR-19-099;
NOT-TR-19-016
R21 (Exploratory)
≥2 CTSA Program hubs
PAR-19-100
Mechanism FOA
Objective
Foster research collaboration to develop, demonstrate and/or
disseminate innovative, experimental approaches to overcoming
translational science roadblocks.
Eligibility
Useful Definitions
CTSA Program Hub:
A UL1 award with a linked KL2 award and an optional TL1 award. A hub that is in no-
cost extension (NCE) status is not considered a currently funded CTSA Program hub
(see https://ncats.nih.gov/ctsa/about/hubs).
CTSA Program Hub Institution:
Includes the recipients of the CTSA Program hub award, as well as any institutions
listed as partners in the CTSA Program hub UL1 awards.
IDeA-CTR Participating Institution:
The lead institution of an IDeA-CTR award or any of the partner institutions of the
IDeA-CTR award.
CCIA (R21)(PAR-19-100)
CCIA (R21 - Exploratory) (PAR-19-100)
Next Receipt Date:
November 8, 2019
Eligibility:
An application must involve investigators who are supported by CTSA Program
hub institutions from at least two different and currently funded CTSA Program
hubs as of the due date of the application.
Hubs in a no-cost extension do not meet the eligibility criteria.
The contact PD/PI must be employed by and/or a recipient of funding from a
currently funded CTSA Program hub institution as defined above in Eligible
Organizations.
Project Period and Budget:
The maximum project period is 2 years.
The combined budget for direct costs for the two-year project period may not
exceed $275,000. No more than $200,000 may be requested in any single year.
CCIA (U01)(PAR-19-099) (NOT-TR-19-016)
CCIA (U01) (PAR-19-099) (NOT-TR-19-016)
Next Receipt Date:
November 8, 2019
Eligible Organizations:
An application must involve investigators who are supported by CTSA Program hub
institutions from at least three different and currently funded CTSA Program hubs as
of the due date of the application or alternatively, an application may involve
investigators from at least two different and currently funded CTSA Program hubs (of
which one must be the contact PI on the application) and one or more currently
funded NIH Institutional Development Award (IDeA) Program Infrastructure for
Clinical and Translational Research (IDeA-CTR) participating institution, as of the
due date of the application. (*Note: This eligibility criterion applies to the IDeA-CTR
awards only, not broadly to the entire IDeA programs such as INBRE and COBRE.)
CTSA Program Hubs or IDeA-CTR participating institutions that are in no-cost
extension (NCE) status do not meet the eligibility criteria.
Eligible Individuals:
The contact PD/PI must be employed by and/or a recipient of funding from a
currently funded CTSA Program hub institution as defined above in Eligible
Organizations. (*Note: As an example, an IDeA-CTR PI will not serve as the one to
submit the CCIA application.)
Investigators who are not employed by and/or a recipient of funding from a CTSA
Program hub institution (such as investigators whom are employed by an IDeA-CTR
participating institution), but who wish to bring an innovative project to the CTSA
Program, can co-direct a project using the multiple PD/PI option in partnership with a
contact PD/PI who holds employment or funding from a currently funded CTSA
Program hub institution.
CCIA (U01) (PAR-19-099) (NOT-TR-19-016)
Project Period and Budget:
The maximum project period is 4 years.
No more than $750,000 or $400,000 (depending on whether clinical research
is involved) direct costs annual budget should be requested.
NCATS is prohibited from direct funding of any 21 CFR-defined Phase III clinical trialunless the target is a rare disease or condition, and must follow certain steps prior to funding (including public notice for ≥120 days)
Applicants and awardees are encouraged to discuss with the PAR-19-099 Scientific Contact regarding any potential for 21 CFR-defined Phase III clinical trial, including changes to planned Phase II clinical trial
*Phase III Clinical Trials (NOT-TR-18-025)
35
CCIA Portfolio Review
36
7
4
76
7
11
18
24
0
5
10
15
20
25
FY16 FY17 FY18 FY19
Nu
mb
er
of
Pro
jec
tsCCIA (U01) Portfolio Growth
New Award
Cumulative
37
Collaborating Institutions
FY18
Max= 8
Min= 3
Max= 6
Min= 4
Mean= 5.7
Mean= 4
Mode= 5
Mode= 3
U01 R21
7 U01; 5 R21 awards
38 unique institutions
FY19
(not final)FY16 FY17
Max= 6
Max= 4
Min= 3
Min= 2
6 U01; 2 R21 awards
1 pending R21 award
25 unique institutions
4 U01; 2 R21 awards
20 unique institutions
7 U01; 0 R21 awards
24 unique institutions
Max=9
Min=3 Min=2
Max=2
Min=4
Max=5
*Note: Counts are approximate only due to the various affiliations among organizations and individuals.
CCIA (FY16): U01 (N=7)
38
• Strengthening Translational Research in Diverse Enrollment (STRIDE) (U01TR001812-01) (UMass)
Engage patients and communities in every phase of the translational process
• Disseminating Curative Biological Therapies for Rare Pediatric Diseases (U01TR001814-01) (Boston Children’s)
• Early Check: A Collaborative Innovation to Facilitate Pre-Symptomatic Clinical Trials in Newborns (U01TR001792-01) (RTI)
Promote integration of special and underserved populations in translational research across the human lifespan
• A National IPS Cell Network with Deep Phenotyping for Translational Research (U01TR001810-01) (BU)
• Leveraging Existing Registry Resources to Facilitate Clinical Trials (U01TR001803-01) (Duke)
Innovate processes to increase the quality and efficiency of translational research, particularly of multisite trials
• Improving Patient-Reported Outcome Data for Research Through Seamless Integration of the PROMIS Toolkit into EHR Workflows (U01TR001806-01) (Northwestern)
• Transformative Computational Infrastructures for Cell-Based Biomarker Diagnostics (U01TR001801-01) (J. Craig Venter Institute, Inc.)
Advance the use of cutting-edge informatics
Addressing CTSA Program Goals:
CCIA (FY17): U01 (N=4); R21 (N=2)
39
• Development, Implementation and Assessment of Novel Training in Domain-Based Competencies (DIAMOND) (U01TR002013-01) (Michigan)
Train and Cultivate the Translational Science Workforce
• Translating Research into Practice: A Regional Collaborative to Reduce Disparities in Breast Cancer Care (U01TR002070-01) (Boston Medical Center) (*co-funded by NIH Office of Behavioral and Social Sciences Research)
Promote integration of special and underserved populations in translational research across the human lifespan
• Investigating Teleconsent to Improve Clinical Research Access in Remote Communities (R21TR002088-01) (MUSC)
• Measure Development to Accelerate the Translation of Evidence-Based Clinical Guidelines into Practice (U01TR002008-01) (NYU)
• Modulation of Gut-Brain Axis Using Fecal Microbiome Transplant Capsules in Cirrhosis (R21TR002024-01) (VCU)
Innovate processes to increase the quality and efficiency of translational research, particularly of multisite trials
• Open Health Natural Language Processing Collaboratory (U01TR002062-01) (Mayo)
Advance the use of cutting-edge informatics
Rural Health-related (N=1)Addressing CTSA Program Goals:
CCIA (FY18): U01 (N=7); R21 (N=5)
40
• TEAMSS – Transforming Expanded Access to Maximize Support & Study (U01TR002488-01) (Michigan)
• Peer-based Retention of people who Use Drugs in Rural Research (PROUD-R2) (U01TR002631-01) (OHSU)
Engage patients and communities in every phase of the translational process
• Impact of Breast Milk on Infant Gut Microbiome (R21TR002516-01) (Rochester)
• Precision Medicine in the Diagnosis of Genetic Disorders in Neonates (U01TR002271-01) (Tufts)
• Transforming Exercise Testing and Physical Activity Assessment in Children: New Approaches to Advance Clinical Translational Research in Child Health (U01TR002004-01A1) (UC Irvine)
• Accelerate cellular immunotherapy development for treatment of life-threatening childhood disorders (U01TR002487-01) (Seattle Children’s)
Promote the integration of special and underserved populations in translational research across the human lifespan
• A platform trial design to accelerate translational therapies in a canine disease model of ALS (R21TR002277-01A1) (UMissouri Columbia)
• Increasing Access to Clinical Microbiome Specimens via a Living µbiome Bank (R21TR002513-01) (MUSC)
• Effects of ApoE-enhancing Compounds on Alzheimer’s Disease Phenotypes In Vivo (R21TR002029-01A1) (Columbia)
• TCR and BCR deep sequencing to distinguish autoimmune recurrence from allograft rejection (R21TR002279-01) (Columbia)
• Harnessing human brain and liver microphysiological systems for testing therapeutics for metastatic melanoma (U01TR002383-01) (Vanderbilt)
Innovate processes to increase the quality and efficiency of translational research, particularly of multisite trials
• Harnessing the power of CTSA-CDRN data networks: Using social determinants of health, frailty and functional status to identify at-risk patients and improve risk adjustment (U01TR002393-01) (UTHSCSA)
Advance the use of cutting-edge informatics
Addressing CTSA Program goals: Opioid-related (N=1); Rural Health-related (N=1)
CCIA (FY19 – Not Final): U01 (N=6); R21 (N=2 + 1 Pending)
41
• Translational Research Workforce Training: Leveraging the Veterinary Specialist (U01TR002953-01) (Wisconsin)
Train and Cultivate the Translational Science Workforce
• Genetic and Functional Dissection of Congenital Anomalies of the Brain (R21TR002770-01) (UNC)
Promote the integration of special and underserved populations in translational research across the human lifespan
• Coordinated medical treatment of opioid use disorder and infectious disease (U01TR002763-01) (Yale)
• SPROUT-CTSA Collaborative Telehealth Research Network (U01TR002626-01) (MUSC)
• ICT Tools for Rare Diseases (R21TR002402-01A1) (RTI)
Innovate processes to increase the quality and efficiency of translational research, particularly of multisite trials
• Unintended Prolonged Opioid Use (U01TR002743-01) (Mayo)
• Instrumenting the Delivery System for a Genomics Research Information Commons (U01TR002623-01A1) (Boston Children’s)
• Enhancing Infrastructure for Clinical and Translational Research to Address the Opioid Epidemic (U01TR002628-01A1) (MUSC)
Advance the use of cutting-edge informatics
Addressing CTSA Program Goals) Opioid-related (N=3); Rural Health-related (N=1)
CCIA Project Highlight (FY16)
Early Check: A Collaborative Innovation to Facilitate Pre-Symptomatic
Clinical Trials in Newborns (U01TR001792-01) (RTI)
Objective:
Establish a voluntary newborn screening research program to study the benefits of
screening for rare disorders so that policy makers will have the evidence they need to
make good decisions about newborn screening policy
Progress:
Program launched in Oct 2018 - https://earlycheck.org//
Objective:
Test strategies to improve retention of people who use drugs in research in rural communities and fosters facilitation of rural participants into clinical trials
Features:
Using rural peer retention specialists: an extension of the “peer navigator” model for study retention
Leveraging Oregon and Appalachian Kentucky and Ohio infrastructure, part of the National Rural Opioids Initiative, a multi-state consortium studying access to care, overdose, and infectious consequences of opioid use disorder in rural America
4343
CCIA Project Highlight (FY18)
Peer-based Retention of people who Use Drugs in Rural Research
(PROUDR2) (1-U01TRTR002631-01) (OHSU)
44
Program Contact:
H. Timothy Hsiao, Ph.D.
Program Director, Division of Clinical Innovation
National Center for Advancing Translational Sciences
Office: 301.594.8928 | e-mail: [email protected]
More Information about the CCIA Program:
Landing Page
FAQ
PAR-19-099
PAR-19-100
CLIC UpdatesDeborah J. Ossip, PhD
The University of Rochester Center for Leading Innovation and Collaboration (CLIC) is the coordinating center for the Clinical and Translational Science Awards (CTSA)
Program, funded by the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH), Grant U24TR002260.
Request for Applications
Un-Meetings
• Apply to host an attendee-driven event without
traditional rules and structure
• One hub will receive funds, planning guidance and
materials, and high-level coordination from CLIC
Application deadline: September 11, 2019
• Learn more: https://clic-ctsa.org/collaboration/clic-un-meetings
• Contact: [email protected]
Synergy Papers
• Apply to collaborate on a manuscript that showcases
a new or transformed assessment or perspective
relative to translational science
• Receive funds and administrative support from CLIC
Application deadline: October 2, 2019
• Learn more: https://clic-ctsa.org/collaboration/clic-synergy-papers
• Contact: [email protected]
CTSA Program Meeting
REGISTRATION DEADLINE EXTENDED• On-Site – September 9th
• ZOOM – September 20th
• Register Here:
• https://clic-ctsa.org/events/2019-fall-ctsa-program-meeting• You will need to be logged into your CLIC account to register (if you do not
have a log-in, you can sign up on the CLIC website)
• Just a few benefits to this change:
• Auto-filling your registration form with information from your account
• Confirm or edit your registration details directly from your account page
• Resend the confirmation letter for your records
CTSA Hub Poster Session
• The 2019 Fall CTSA Program Meeting will kick off with a Hub Poster Session.
• Thursday, September 26th from 6:00 PM to 8:00 PM ET
• Theme: CTSA Program Optional Cores
• 1 poster per hub
• Electronic versions of the posters will be available
• You will need to log into the website before you click “to submit a poster”
• SUBMISSION EXTENSION!!• New Deadline to Reserve Spot– September 9th
• Complete the abstract to reserve your hub’s spot
• The posters do not have to be finalized to reserve your spot
• New Deadline for Final Details – September 16th
• Upload final poster by COB September 16th
CLIC Website Updated!!
CLIC Website Upgrade• To create changes based on user interaction, user analytics and
suggestion box comments
• To prepare for the new group structure
CLIC Homepage Interaction Heatmap
75% of users
50% of users
25% of users
New Group Structure
New Homepage
Consortium submitted content higher on the page• Use of colored labels to show content type
Maintained rotating banner for high visibility news
Login - Here
Expanded menu bar
Group Pages – New Look
Improved Account Page
Share Content
Once logged in click
on “Share Content” at
the top of any page to
access the
submission forms
Contact CLIC
DTF to EC Transition Updates
Application ProcessMany questions are similar to what was
included previously in Working Group
Charters:
• Purpose
• Goals
• Deliverables
• Timelines
A few new questions:
• How does this WG differ from or
complement current efforts?
• If sponsored by an EC, you will need to
upload a letter of support from the lead
team
• Expected impact
• Expertise needed to accomplish goals
Application Process
NEW
• You will have a chance
to select from this list of
additional support/resources
from CLIC, CD2H and TIN.
Revised Submission Timeline For Round 1
System
Live
Proposals
Due
SC Review Earliest
WG Start
Oct 1 Oct 31 Nov 15-
Dec 8
Jan 1
CLIC/NCATS Communication ChannelsSharing Content: CLIC Website
News (Consortium News & WOW! Factor stories):
clic-ctsa.org/news
Events: clic-ctsa.org/events
Educational tools (Education Clearinghouse): clic-
ctsa.org/education
Funding opportunities (RFAs):
https://clic-ctsa.org/collaboration/clic-synergy-
papers
https://clic-ctsa.org/collaboration/clic-un-
meetings
Career & training opportunities (Opportunities
Board): https://clic-ctsa.org/opportunities-board
NCATS: twitter.com/ncats_nih_gov
CLIC: twitter.com/CLIC_CTSA
Hashtag: #CTSAProgram
CLIC Contact Us
Have a question and not sure where to direct it?:
clic-ctsa.org/contact
Newsletters
CTSA Ansible: Subscribe Here
CLIC News Roundup: Subscribe Here
NCATS e-Newsletter: ncats.nih.gov/enews
CTSA Program Initiative Channels
ACT Network
Website: http://www.actnetwork.us/National
Subscribe to newsletter:
https://bit.ly/2HQGsM5
IREx
Website: https://www.irbexchange.org
Subscribe to newsletter: https://bit.ly/2TtQG7b
National Center for Data to Health
(CD2H)
Website: http://www.actnetwork.us/National
Subscribe to newsletter:
https://bit.ly/2HQGsM5
Recruitment Innovation Center (RIC)
Website:
https://trialinnovationnetwork.org/recruitment-
innovation-center
Subscribe to newsletter:
https://bit.ly/2OpEDHc
SMART IRB
Website: https://smartirb.org
Subscribe to newsletter: https://bit.ly/2JFbiK3
Trial Innovation Network (TIN)
Website: https://trialinnovationnetwork.org
Subscribe to newsletter:
https://bit.ly/2TXHQDZ
Questions?
Reminders
• September’s CTSA Program Webinar is CANCELLED.
• The next scheduled webinar will be Wednesday, October 23rd,
2:00 PM – 3:00 PM Eastern Time
• https://clic-ctsa.org/groups/ctsa-program-group