CTSA Program PI Webinar Wednesday, November 28, 2018 2:00 3:00 ET - - PowerPoint PPT Presentation

CTSA Program PI Webinar

Wednesday, November 28, 2018 2:00 – 3:00 ET

Agenda

Time Topic Presenter 2:00 - 2:15 Welcome NCATS and CTSA Program Updates Michael Kurilla 2:15 - 2:25 CLIC Update

• Common Metrics Update
• Contest Announcement

Deborah Ossip (CLIC) Laura Meyers (CLIC) 2:25 - 2:55 DIAMOND Update / Discussion Vicki Ringold & Team 2:55 - 3:00 Adjourn

2

NCATS and CTSA Program Updates

Michael Kurilla

FY 2019 Budget

ØMinibus: Department of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019 and Continuing Appropriations Act, 2019 (P .L. 115-245)

• NIH: $39.084 billion ($2 billion increase, or 5.4%, above FY 2018)
• NCATS:

FY 2017 ($M) FY 2018 ($M) FY 2019 ($M) NCATS 705.9 742.4 806.4 CTSA 516.1 542.8 559.8 CAN 25.8 25.8 “up to 80.0”

FY 2019 Budget

Ø Appropriation report language:

• Senate: Clinical and Translational Science Awards [CTSA] Program.—The Committee encourages the NCATS

to fund, through the existing CTSA Program hubs, expanded efforts to improve translational research that address health disparities and the significant burden of conditions that disproportionately affect minority and special populations. Accelerating translational research by making it more efficient and effective will reduce the burden of disease and promote health equity. Applying the CTSA model to address longstanding regional health disparities can provide innovative, multidisciplinary approaches to reducing the burden of disease among vulnerable populations. The Committee supports the goals of the NCATS program and believes the principles that serve as the foundation of NCATS; public-private partnerships, community

• utreach, faster access to clinical trials, have tremendous potential for addressing the long-standing

diseases associated with health disparities. The Committee encourages NCATS to fund institutions with a history of serving health disparity populations.

• House: Rural Health Outcomes and Health Disparities.—The Committee notes translational science and

education is critical to developing new treatments and healthcare approaches that can be disseminated to underserved and special populations to improve health outcomes across the life span. The Committee continues and encourages NCATS, through its CTSA program, to enhance its commitment to the value of translational science and funding for universities to continue to innovate by leveraging statewide resources and capabilities to improve rural health outcomes and eliminate health disparities. The Committee requests an update on the actions within the CTSA program to improve rural health outcomes and health disparities in the fiscal year 2020 Congressional Justification.

CTSA Program Administrative Reminders and Updates

• 1. Provided to PIs and Administrators via 10/31/2018 email:
• Carryovers
• Information and guidance on requesting carryovers can be

found on the CTSA Program consortium website here.

• Research Performance Progress Reports (RPPRs)
• Updated 2019 Specific Guidelines for Research Performance

Progress Reports (RPPRs) for the Clinical and Translational Science Awards (CTSA) Program here.

• Send questions to: CTSARPPRQuestions@mail.nih.gov
• 2. Provided to PIs and Administrators via 11/13/2018 email:
• CTSA Program Communications Guidance Document
• NCATS CTSA Program consortium website: https://ctsa.ncats.nih.gov/governance-

guidelines/guidelines/success-story-form/

• CLIC website: here and on the CLIC’s News page and will soon be added to CLIC’s

Communications Toolkit (remember to login to access).

NIH RFI: Draft Data Management & Sharing Policy Notice Number: NOT-OD-19-014

• NIH Seeks Public Comment on Proposed Provisions for a Future Draft

Data Management and Sharing Policy. Feedback will help to inform the development of a draft NIH policy for data management and sharing, which is expected to be released for an additional public comment period upon its development.

• Comments on the proposed key provisions will be accepted

through December 10, 2018, and can be made electronically by visiting here.

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Seeking New Steering Committee Members

NCATS is seeking nominations for new CTSA Program Steering Committee (SC) members! We have 5 total slots available – 4 UL1 PIs and 1 Administrator SC member. If you would like to self-nominate or suggest a fellow PI, please submit the PI name, institution, and brief explanation (no longer than 1 paragraph) to Samantha Jonson (Samantha.Jonson@nih.gov) by Friday, November 30th. The eligibility criteria for SC appointments for PIs (UL1, KL2 and TL1) and an Administrator are as follows:

• A PI must be officially named in the Notice of Grant Award of an active CTSA Program hub
• An Administrator is the key point of contact between their institution’s CTSA Program leadership and

Program Directors, and NCATS personnel

• An “active” award is defined as a hub award that is not in a No-Cost Extension (NCE). A PI or

Administrator whose hub award in an NCE is not considered eligible as there is insufficient time remaining in the award project period for initiation of an appointment.

• For both PIs and Administrator, their hub award must have at least 3 years remaining during the

project period

• An eligible PI has not served on the SC since December 2014

To learn more about the roles and responsibilities, please visit this web page.

NOT-NS-19-022: Notice of Intent to Publish a Funding Opportunity Announcement for HEAL Pain Effectiveness Research Network: Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required)

• This Notice of Intent to Publish a Funding Opportunity Announcement was released

yesterday (HEAL Pain Effectiveness Research Network: Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3). It is about the program under consideration that will conduct effectiveness clinical trials to establish best practices to prevent or manage acute or chronic pain in ways that reduce the risk for addiction.

• The notice is a fairly comprehensive summary of the future RFA under
• consideration. Please take time to read it.
• The TIN will act as the Clinical Coordinating Center, the Data Coordinating Center

and provide biostatistical support as needed. The TIN will work with the Clinical and Translational Science Awards (CTSA) hubs ( https://ctsa.ncats.nih.gov/ ) and other sites identified by awardees to implement studies.

• We are asking that each CTSA hub have a HEAL TIN liaison point of contact for

these studies.

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NIH HEAL Initiative: Program Update and Funding Opportunities for Pain Research Available through NIH

• This presentation was given by Dr. Walter J. Koroshetz, MD, Director of the

National Institute of Neurological Disorders and Stroke (NINDS), at an AAMC

• webinair. He discussed all of the new pain research programs and those

under consideration that are part of the trans-NIH HEAL Initiative. This includes the Pain Effectiveness Research Network (Pain-ERN).

• Links to the slides and recording are at https://www.aamc.org/initiatives/rocc/
• The Pain ERN is mentioned on slide 9, and this slide demonstrates how the

network fits in with the other planned HEAL programs. Slide 27 gives a more complete description of the Pain ERN program.

• Also notice the other clinical HEAL studies that could involve your CTSA.
• See more about planned and available funding opportunities at

https://www.nih.gov/research-training/medical-research-initiatives/heal- initiative/funding-announcements-opportunities.

10

Source: Koroshetz, W.J. (2018, November 8). NIH HEAL Initiative: Program Update and Funding Opportunities for Pain Research Available through NIH (Webinar). In Research on Care Community Webinar Series. Retrieved from https://www.aamc.org/initiatives/rocc/

Common Metrics Initiative: Longitudinal CM Report

PI Webinar November 28, 2018

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.

Objectives

• 1. To show hub quantitative trend values relative to

consortium data.

• 2. To illustrate changes in hub data relative to consortium

since 2016 going into 2017.

• 3. To identify qualitative factors involved in turning the

curve since 2016.

• 4. Generate questions and hypotheses, allow exploration -

“What if...”

Goal

To provide both a quantitative and qualitative longitudinal perspective of the Common Metrics data for 2015, 2016, and 2017.

Quantitative Methodology

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.

Obtain 2017 CM Data Extract on 10/1/2018 Clean the data Calculate Median, IQR for all Numerical Data 2015 - 2017 2015 -2017 longitudinal plots for each hub Identify "exemplars”; Change in metric value from 2016 - 2017

Quantitative Results

For all numerical metrics:

• Illustrate year over year trend for your hub

as well as the consortium

• Your hubs annual reported results as well

as the consortium

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.

For all numerical metrics show:

• Change in reported value from 2016 – 2017
• Identify “exemplars” – hubs with the most change in

the “right direction”

2015 -2017 Longitudinal Plots 2016 – 2017 Change in Metric Value

TTC Plan Analysis

• Identify common themes/practices among de-identified

exemplar hubs.

• May include analysis through QDA Miner software / Inter-

Rater Reliability.

• Best practices of de-identified exemplar hubs will be

shared in reports sent to NCATS and hubs.

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.

Communication Plan: Next Report

Stakeholder Groups:

• Steering Committee
• PI Webinar
• Common Metrics Executive Committee
• CTSA Program Evaluators

The goal of presenting at these calls is twofold:

• 1. to engage the community in the CM report process, and
• 2. to seek comments and feedback to ensure visualization

clarity and improve descriptions of our visualizations Target Report Date: February 28, 2019

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.

CMI Upcoming Activities

Accrual Median Metric Development Team

• December 7, 2018
• January 23, 2019

Targeted 2017 Hub Report

• February 28, 2019

2017 Hub Report Webinar

• March 18, 2019
• March 21 OR 26, 2019

RBA Tool Review – April 8, 2019

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.

Informatics Final Phase 1 Office Hour – December 10, 2018 Informatics Phase I completion – December 31, 2018 Informatics Phase 2 – February 4, 2019 Informatics Phase 2 completion – March 31, 2019

CLIC CM Contact

common_metrics@clic-ctsa.org

Newsletter Naming Contest: Re-name the CTSA Program Update

What

• Revamping the CTSA Program Update
• Streamline content
• Modernize look & feel

Why

• Feedback from consortium that the current update is

lengthy, difficult to navigate, repetitive w/ other communications

What we need from you

• Your creativity!
• CLIC/NCATS are hosting a contest to re-name the

CTSA Program Update

• Accepting online submissions until Dec. 31:

clic-ctsa.org/form/newsletter-naming-contest-re-name- ctsa-program-update

• No submission limit per individual or hub
• Will reveal winning name in new & improved January

newsletter issue (Jan. 11)

YOUR NAME HERE

contactdiamond@umich.edu

The DIAMOND Mission

Deliver a sustainable, collaborative discovery learning space for clinical research professionals (CRPs) working in CTSA institutions & partners. DIAMOND includes:

• Access to competency-based clinical research training offerings and

assessments

• An easy way to contribute training and assessment materials to the

collection

• Access to an ePortfolio system to encourage workforce development

and connection

2014

ECRPTQ Phase I

GCP Training Recommendations for PIs and CRCs

NIH/NCATS- UL1TR000433-08S1 doi:10.1017/cts.2016.2

2015

ECRPTQ Phase II

Developing a competency-base for PI and CRC Education and Training

NIH/NCATS- UL1TR000433-08S1 doi:10.1017/cts.2016.2

2017

DIAMOND

Developing a competency based educational portal, assessments and ePortfolio for CRPs

NIH/NCATS- U01TR002013 [Umich, OSU, Rochester, Tufts]

Evolution of DIAMOND

DIAMOND Partners

• University of Michigan
• The Ohio State University
• University of Rochester
• Tufts CTSI

DIAMOND Contributors

• Northwestern University
• Mayo Clinic
• Duke University
• Nationwide Children’s Hospital
• ACRP

The DIAMOND Team

Access DIAMOND through CLIC or diamondportal.org

DIAMOND ePortfolio

• Portal: 63% new

visitors, 37% returning visitors

• Visits from across

the U.S., China, and India

• 22 active Portfolio

users

• 13 connections

between users

DIAMOND Users

DIAMOND Portal DIAMOND ePortfolio

• The DIAMOND portal is free for all users to contribute materials and

browse materials in the collection

• Portfolium is a free platform that can be used for clinical research

professionals utilizing DIAMOND

• Your Portfolium accounts through DIAMOND will remain accessible

for life

What Does This Cost?

Questions?

Contact the DIAMOND group administrator at: contactdiamond@umich.edu