CTSA Program Webinar Wednesday, July 22, 2020 2:00 PM 3:00 PM ET - - PowerPoint PPT Presentation

CTSA Program Webinar

Wednesday, July 22, 2020 2:00 PM – 3:00 PM ET

Agenda

2

Time Topic Presenter

2:00 PM – 2:10 PM Welcome NCATS and CTSA Program Updates Michael G. Kurilla, M.D., Ph.D. 2:10 PM – 2:15 PM Competitive Revisions Updates Pablo Cure, M.D., MPH Program Director, Division of Clinical Innovation NCATS NIH 2:15 PM – 2:50 PM TIN Updates Jane Atkinson, D.D.S. Consuelo Wilkins, M.D. Paul Harris, Ph.D. Danny Benjamin, M.D., Ph.D. Dan Hanley, M.D. Trial Innovation Network (TIN), NCATS NIH 2:50 PM – 3:00 PM Report from “An Un-Meeting on Lifespan and Life Course Research: Integrating Strategies” Susanna McColley, M.D. Associate Clinical Director of Child Health Translational Sciences Institute Northwestern University Feinberg School of Medicine 3:00 PM Adjourn

CTSA Program Updates

Michael Kurilla

Opportunities & Administrative Updates

4

NIH Rapid Acceleration of Diagnostics (RADx) Initiative

https://www.nih.gov/research-training/medical-research-initiatives/radx

• Support innovative technologies to make more rapid SARS-CoV-2 tests (in

the millions) available in US by late Summer or Fall in support of safe return to normal life

• National call for scientists and organizations to bring their innovative ideas

for new COVID-19 testing approaches and strategies

• Technologies, devices, and strategies

RADx Components

• RADx-Tech: Innovative point-of-care and home-based tests; improve clinical

laboratory tests that can directly detect the virus. https://www.nibib.nih.gov/radx-initiative-covid-19-testing/FAQ

• RADx-UP: Understand factors associated with disparities in COVID-19 morbidity and

mortality in underserved populations and to lay the foundation to reduce disparities

• RADx-rad: Support new, non-traditional approaches, including rapid detection

devices and home-based testing technologies, that address current gaps in COVID- 19 testing

• RADx-ATP: Increase testing capacity and throughput by identifying existing and late

stage testing platforms for COVID-19 that are far enough advanced to achieve rapid scale-up or expanded geographical placement in a short amount of time; efforts will focus on scaling up technologies and improving existing high-throughput platforms

RADx-UP New Funding Opportunities

• Community-Engaged Research Testing Research Projects

Limited Competition Emergency Competitive Revisions NOT-OD-20-121 Due: August 7, 2020

• Community-Engaged Research on COVID-19 Testing

Emergency Competitive Revisions NOT-OD-20-120 Due: August 7, 2020; September 8, 2020

• Social, Ethical, and Behavioral Implications (SEBI) Research on COVID-19 Testing

Emergency Competitive Revisions NOT-OD-20-119 Due: August 7, 2020; September 8, 2020

• RADx-UP Coordination and Data Collection Center RFA-OD-20-013

Due: August 7, 2020

Human Subjects Research (HSR) Studies Process Change

• Additional Temporary Change to New Domestic KL2 Scholar projects that involve

HSR (effective July 9, 2020)

• Formal Prior Approval requirements are suspended for domestic COVID-19-related

and non-COVID KL2 Scholar HSR Category 2 studies (not a clinical trial and are minimal risk or exempt).

• Category 2 studies may begin after entry into the eRA HSS along with NCATS-

specified documentation and email notification of NCATS at NCATS_CTSA_Pilot_HS@mail.nih.gov.

• All UL1 Pilots and KL2 Scholar projects that include Category 1 studies (greater

than minimal risk or a clinical trial) or include a foreign component continue to require formal Prior Approval.

HSR Requirement Reminders

• Harmonized UL1 Pilot and KL2 Scholar project requirements (at least

temporarily)

• Email notification of NCATS for Process Types
• Standard & Expedited Prior Approval: NCATSPriorApprovalRequest@mail.nih.gov
• Notification & HSS Study Entry: NCATS_CTSA_Pilot_HS@mail.nih.gov
• Addendum and Instructions for PIs and SOs version 1.0 is required (here)

https://ctsa.ncats.nih.gov/governance-guidelines/guidelines/new-projects-with-human-subjects-research/

• Critical to expedite review and approval
• The form has not been updated with temporary changes; follow the

instructions that match your HSR study categories and process types.

Current HSR Study Categories & Process Types

Mechanism

UL1 Pilot or KL2 Project

Study Risk Category Category 1 Greater Than Minimal Risk

• r Clinical Trial

Category 2 Minimal Risk or Exempt (non-Clinical Trial) Study Focus Non-COVID COVID-19 Non-COVID COVID-19 Process Type Standard Prior Approval Expedited Prior Approval Notification & HSS Study Entry Notification & HSS Study Entry

Upcoming Webinars

• August: Cancelled – BUT…
• … we need your input for the Oct. webinar
• September 23 webinar: Dr. Kurilla’s annual “State of the CTSA Program”

(tentative)

• October 28 webinar: Focus on human subjects-related topics
• Submit your questions/issues to the CLIC suggestion box by October 5
• Also submit best practices that address common problems and you’d like to share

Competitive Revision Awards

Pablo Cure

CTSA Program Competitive Revision Awards

PAR-19-337

Purpose:

Solicit UL1 competitive revision applications for the demonstration, and/or dissemination, and/or implementation of highly innovative and impactful translational science projects that address the goals of the CTSA Program, have been tested and validated at a specific hub or institution, and are beyond the original scope of the approved parent project

Funding Instrument:

Cooperative Agreement

Eligibility:

Active UL1 parent awards (not in NCE)

Award Budget:

$750,000/year in direct costs excluding consortium/contractual F&A costs

Project period:

1 to 3 years provided it is within the remaining project period of the UL1 award

Due Dates:

September 25, 2019; September 25, 2020; September 27, 2021

Letter of Intent:

30 days prior to the application due date

Application Instructions:

Please refer to PAR-19-337 for complete instructions.

Review and Selection:

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by NCATS

• Parent award (UL1) must be active (i.e. not be in an

extension period), and the research proposed in the supplement must be accomplished within the remaining active project period for the existing UL1 parent award.

• Projects with a total proposed duration of less than one

year will not be accepted.

• Requested project period may be from 1-3 years provided

it is within the remaining project period of the current UL1 award.

Eligibility

• Demonstration, and/or dissemination, and/or implementation of new

activities and/or capabilities successfully developed at one hub to be tested at

• ther hubs.
• Efforts to promote the sharing of resources and capabilities across different

CTSA Program hubs.

• Efforts to disseminate expert knowledge and create that expert capacity at

additional CTSA Program hubs.

• Sharing and/or expansion of a platform developed and demonstrated to be

impactful in the translational science space at a single hub that will be adopted at multiple hubs.

• Expansion of consortium-wide capabilities.

Proposed capability has been tested/validated and has led to a measurable impact at the local hub.

Examples of the types of projects that would be considered for support under this FOA include, but are not limited to:

Page Limitations

All page limits described in the SF424 Application Guide and the Table of Page Limits must be followed. Note: We recommend applicants to use a different application title than the Parent UL1 grant title in their competitive revision applications. This to avoid duplication in cases where more than one application is submitted by the same hub. Only one competitive revision application to a UL1 hub may be funded per year.

• Addressing a systemic barrier in clinical and translational

science

• Evidence that the proposed capability is ready for use

and dissemination

• Capability Dissemination and Implementation Plan
• Evaluation and Sustainability Plan
• Program Director/Principal Investigator

Research Strategy

• Failure to follow SF424 Instructions:
• For studies that will include the use of previously collected biospecimens, data or

records, lack of description regarding the source of these materials, whether these can be linked with living individuals, and who will be able to link the materials.

• For Human Subjects Research Claiming Exemptions: lack of justification of why the

research meets a specific exemption category.

• Lack of description regarding the process for obtaining informed consent
• Lack of description regarding planned strategies for protecting against or minimizing

all potential risks identified, including strategies to manage and protect the privacy of participants and confidentiality of research data.

• Inclusion plans that are not justified or with insufficient details (i.e plans for

inclusion of children, inclusion of women and minorities).

• Failure to recognize observational research on users as Human Subject Research

(45 CFR 46).

• Failure to include in the Research Strategy a Dissemination and Implementation

Plan and/or Evaluation and Sustainability Plan

Common Mistakes

• Informational webinar/presentation: July 22, 2020
• LOI: August 26, 2020 (30 days prior to receipt date)
• Receipt: September 25, 2020
• Review: February 2021
• Council: May 2021
• Earliest start: July 2021
• Resubmissions: Not Applicable. Only New Applications will

be considered.

Next Key Dates

Notice of Special Interest (NOSI): Clinical and Translational Science Award (CTSA) Program Applications to Address 2019 Novel Coronavirus (COVID-19) Public Health Need For more information refer to: NOT-TR-20-011

Questions?

• Please review FOA: PAR-19-337
• Scientific/Research Contact: pablo.cure@nih.gov
• Peer Review Contact: victor.henriquez@nih.gov
• Financial/Grants Management Contact: irene.haas@nih.gov

CTSA Program Meeting Trial Innovation Network

July 22

TIN COVID Activities

SINGLE CTSA SITE INITIATED

• 22 Emergency TIN trial consults
• From 13 distinct institutions
• Rapid deployment of trials
• 2 HCQ outpatient
• 3 CP outpatient
• 1 CP inpatient
• Rapid deployment of four DSMBs
• 2 CP outpatient
• 2 HCQ outpatient

MULTI-SITE EXPANSION

• Provide CTSA network data for ACTIV program
• RIC provided support for 22 COVID TIN studies
• Initiate 2 multisite COVID-19 outpatient CP trials in TIN-CTSA network
• ~ 20 CTSA sites
• Prophylaxis and early infection CP
• CTSA-TIN coordination approach for emergency trials
• Shared DSMB data across trials
• Pooling of analysis across trials
• Network’s approach to emergency trial response
• Develop NCATS-CTSA ACTIV master resources
• Coordinating the EOI process for the trans-CTSA ACTIV platform

master protocol

• 3 interventions
• Engaging 40-50 CTSA network sites

PENDING

• DSMB for School Boards to

advise on school re-opening and school safety

Enh nhanc ncing ing Mino nori rity ty Recr cruitmen itment t in n COV OVID ID-19 9 T ri rials ls

Recruitment Innovation Center Principal Investigators: Paul l A. . Harris, , PhD hD; ; Professor of Biomedical Informatics Consuelo uelo H. W . Wilk lkins, ns, MD, , MSC SCI; Professor of Medicine Vanderbilt University Medical Center

COVID lifespan progression

Striking Disparities in COVID-19

Long-standing systemic health and social inequities have put some racial/ethnic minority groups at increased risk of COVID-19 or experiencing severe illness, regardless of age.

https://www.cdc.gov/coron avirus/2019-ncov/need- extra-precautions/racial- ethnic-minorities.html

Higher COVID-19 rates among people speaking languages other than English

Common Barriers Scientist –level barriers  Limited experience recruiting minorities  Lack relationships with community orgs  Few, if any, minority researchers Participant-level barriers  Perceived harms, fear, mistrust  Costs, transportation, access, convenience  Info unavailable in preferred language Study-level barriers  Budgets inadequate for recruitment  No expertise to culturally tailor documents  Lack of culturally congruent research staff Study-Specific Barriers

• Misinformation about COVID-19
• Concerns re safety of COVID-19 tests, treatments, vaccines
• Limited access to testing and care
• Fears related to government involvement
• Contact tracing
• Information being shared w/ law enforcement
• Stigma related to COVID-19
• Lack of dedicated staff to support recruitment
• No information/resources for family and household members

involved in decision making

• Study materials not available in multiple languages
• Minimal/no involvement of trusted leaders/community orgs

Heller et al. Strategies addressing barriers to clinical trial enrollment of underrepresented populations: a systematic review. Contemp Clin Trials. 2014;39(2):169-182. Schmotzer GL. Barriers and facilitators to participation of minorities in clinical trials. Ethn Dis. 2012;22:226–30

Comprehensive Approaches to Minority Recruitment

Enabling Minority Recruitment

• Identif

ntify sit ites es wi with capacity acity to recrui cruit min inori ritie ies s

• Contact sites with higher % minorities
• Questions on site selection to determine interest/capacity
• Prior experience recruiting minorities, bilingual staff
• Support

rt facili ilitie ies s in in min inori rity y recrui cruitment ment

• T

raining in minority recruitment

• Culturally tailored recruitment materials
• Information to address fears related to radiation

Enabling Minority Recruitment (cont)

• Increase

rease pip ipeline line of referr erral als s to COVID ID-19 19 resea search rch sit ites es

• Identify primary care and community champions
• Professional and community-focused orgs, National Med

Assoc, National Hispanic Med Assoc

• Cr

Creat ate awa wareness reness of study

• National campaign; using tailored messaging
• Partne

ner wit ith trust sted ed commun unity ity organ ganiz izat ation ions

• Engage through trusted community organizations
• Support families in decision making and study participation

Ongoing RIC COVID Activities

• Image gallery of diverse photos vetted by ResearchMatch

Expert Advice group

• eConsent-tools and best practices for COVID
• “How to” Videos
• ResearchMatch translated into Spanish
• Social media campaigns (FB paid ads) for

ResearchMatch

• Community Engagement Studios for tailored

messaging & creative feedback

Figure 2: RIC procedural video (for first TIN COVID-19 trial)

COVID-19 - Library of Recruitment Materials

General materials Study specific Examples of local materials (translated)

eConsent

eConsent has addressed the problems of:

• How to continue doing

research studies during a pandemic?

• How to do studies with

COVID-19+ participants and keep everyone safe, preserve PPE, and reach LARs, parents, translators, etc., when everyone is remote?

YouTube Channel for eConsent education videos: https://www.youtube.com/playlist?list=PLiMlsWK5xzDsjG_slun3JTDJxIzVWOlR2 Recent publication: REDCap based model for electronic consent

MyCap

MyCap provides the ability to collect valuable data in the outpatient, post- discharge, and recovery contexts such as:

• Medication changes
• New hospitalization
• Symptoms
• Need for follow-up

Soon to be available in Spanish And Portuguese!

RIC Community Advisory Board (CAB)

Diverse National RIC CAB has reviewed COVID trials; provided input recruitment

• Ask communities what they need
• Provide and offer resources and services
• Work with/support community-based orgs that

serve to minority communities

• Be transparent about study goals and provide

simple explanation of any associated risks

• Request secondary contact information to ensure

follow up

• Provide equitable compensation to study

participants

• Return study results to community

Awareness Oppo Opportunit ity Ac Acceptance Co Cons nsent Enr Enrol

• llment

Retentio ion Retu turn of

• f

Resu esult lts

Recruitment Continuum: Example COVID Vaccine Trials

Community Partners National Campaign Tailored Recruitment Materials Consent forms in multiple languages Culturally congruent staff MyCap in translated versions Results to Community & Providers

Trial Innovation Network

ACTIV-1 – RAMP-C EOI

EHR Cohort Assessment and Interested PI

Trial Innovation Network

Goals of the presentation

• Provide a summary of the results of the Expression of

Interest and Study Specific Site Feasibility Survey for the ACTIV-1 trial

• Showcase the strengths of the TIN-CTSA collaboration to

quickly identify interested PIs across the United States using existing processes and infrastructure

Trial Innovation Network

EOI Sent June 25, 2020 following a PI lead webinar Responses Due July 2, 2020

EHR Cohort Assessment (EHR based COVID patient #s) Interested PI # Total Responses 68 (10 affiliates) 69 (14 Affiliates) % Response Rate 86% 84% % Opt Outs 18% 16% % With Results 82% (58) 82% (56) Average Response Time 7 Days 9 Days

Trial Innovation Network

ACTIV-1 – RAMP-C Key dates Study Specific Feasibility Survey

Survey Sent: July 12, 2020 to 56 interested PIs Responses Due: July 17, 2020 Responses as of Date: July 19, 2020: 42 (77%) Average Response Time: 3 Days

Trial Innovation Network

ACTIV-1 –RAMP-C FAQs of Interest

What about sites participating in the ACTT or other trials involving similar populations? ACTT 1 and ACTT 2 may be nearing

• completion. Sites participating in other studies enrolling similar populations

may also participate in ACTIV-1. In such cases, we recommend rotating enrollment across the trials in a pre-specified manner Is there a formal feedback mechanism for the ACTIV-1 trial? As ACTIV-1 gets operationalized, there will be opportunities for CTSA/TIN investigators to participate in the steering committee. In addition, there will be an opportunity for participating CTSAs to nominate a person to serve as the protocol chair.

Trial Innovation Network

Power of the TIN-CTSA Collaboration

• Through the TIN-CTSA collaboration and existing

TIN infrastructure, over the course of 3 weeks we:

• Received EHR based numbers of COVID patients from 58 CTSAs

and affiliates

• Identified 56 interested PIs across the CTSA network and

affiliates

• Received 42 study specific feasibility surveys

Trial Innovation Network

How to get Involved

If you are interested in participating: Contact: Cecile Santiago-Turla santi007@duke.edu Next Steps

• Follow-up on additional sites that have not responded
• Protocol PI and NCATS to review the survey responses
• Select sites to participate

CTSA Program Meeting

TIN-CTSAs Coordinated Approach for Emergency Studies Update July 22

• DSMB Approach
• Joint Analyses Approach

Goal and Outcome of Presentation

Goal: * Update on Coordinated Approach for Emergency Studies * Provide TIN analytic support to PIs willing to participate Outcome: * Solicit more collaboration and participation from the CTSA teams * Define the pathway by which additional protocols can be added to the Covid-19 Collaboration Platform

Current COVID trial Landscape –Coordinated Assistance Program

• I. Hydroxychloroquine
• Current inpatient studies no longer recruiting
• DSMBs not making new stopping criteria decisions
• Less immediate benefit for sharing data for DSMB decision making
• Strong interest in pooled analysis

II. Convalescent Plasma

• Studies still accruing with potential for safety/efficacy input
• DSMBs can benefit from data shared intermittently for safety/efficacy

decision making

• PIs have strong interest in pooled analysis

TIN Coordinated Assistance for Emergency Studies

Effort 1 - DSMB Approach Define a group of DSMB Chairs that wish to collaborate around DSMB and Safety

• Foster connections with study teams and individual study DSMB leaders
• Aggregate protocols, statistical plans, endpoint variables, and data dictionaries
• Confirm study investigator teams wish to collaborate
• Develop statistical graphics and software for clinical trial reporting for DSMBs

Effort 2 - Joint Analyses Approach Define investigator groups willing to collaborate around conduct and analyses in clinical trials

• Foster additional connections between investigators and TIN statisticians
• Organize investigator meetings by intervention type
• Define areas of consonance and dissonance between studies
• Define comparator or control group(s)
• Define common data definitions
• Aggregate data or build common analytic pathways
• Organize long term data storage

Outreach Timeline

6/8 Presentation to CTSA PI Steering Committee

May June 2020

5/8-5/28 Expression of Interest sent to CTSA Teams 6/29 Survey additionally sent to those who completed EOI

July

5/6 PI-led webinar to CTSA Liaison Teams 5/5 Presentation to CTSA Liaison Team Points of Contact 6/11 Follow–up letter & survey sent to CTSA SC and pods July 20-24 Streamlined TIN outreach 7/22 CTSA Program Meeting presentation 5/11 Outreach discussion with CLIC team 6/11 Update to CTSA Program Steering Committee Meeting 7/17 Follow–up letter & survey sent to CTSA SC and pods

Aggregate Survey Results

Response: 27 entries from 16 CTSAs (6 CTSAs with >1 entry)

• Willingness to share their study protocol:
• 19/27 yes
• 6/27 not the primary site and/or their trial was sponsored
• 2/27 no and did not give a reason
• Willingness to contribute trial data:
• 13/27 not sure
• 8/27 would share patient level
• 6/27 would share their data element definitions
• 6/27 would share safety data

JHU-Tufts TIC and Covid-19 Collaboration Platform

Engagement of Investigators

• Pediatric Convalescent Plasma – 16 sites doing single site work; 4

meetings

• Adult Inpatient Convalescent Plasma – 4 sites undertaking a Pooling

analysis – Led by Albert Einstein & NYU

• Adult Outpatient Convalescent Plasma – 3 multisite studies considering

pooling for analysis; committed to shared data for DSMB

• Adult HCQ - 11 sites committed to pooled analysis – data harmonization

initiated.

• Adult Other interventions – 5 non HCQ/CP trial participants submitted

protocols http://covidcp.org/

Progress – Joint Analysis

 Establish a governance and leadership structure  Engage trial PIs of HCQ and Convalescent Plasma  Host meeting of HCQ PIs interested in data sharing  Establish plan for sIRB approval  Explore barriers, facilitators, and opportunities for CTSA engagement in a coordinated approach for emergency studies  Establish a joint data use agreement to use with Vanderbilt RIC’s DSMBc project  Standardized statistical analysis plan and supporting data dictionary  Register and publish results of a planned pooled analysis of trials in ClinicalTrials.gov

Progress - DSMB

 Establish a governance and leadership structure  Determine the IRB requirements to support initiatives  Develop statistical software for synchronized DSMB reports  Identify single therapeutic (convalescent plasma)  Engage trial PIs of therapeutic  Establish plan for sIRB approval  Establish a joint data use agreement to use with JHU-Tufts TIC’s Data Pooling/Joint Analysis project  Garner IRB approval ฀ Onboard 3-4 trials of single therapeutic (convalescent plasma)

Question & Answer

Next Steps and Contact

• Interested PIs can upload their protocols to the Covid-19 Collaboration

Platform http://covidcp.org/

• For more information about the initiatives, complete a short informative survey with more

information: survey (https://jhmi.co1.qualtrics.com/jfe/form/SV_3krDoXwJ0dGNezX)

• Contacts below for more information:

Marianne Gildea, JHU-Tufts TIC, mgildea1@jhmi.edu Terri Edwards, Vanderbilt RIC, terri.edwards@vumc.org

Thank you

Additional Background

Proposed Strategy

I. Pooled Analysis (JHU)

• HCQ: VUMC leverage current PI contacts to assist JHU with data requests for

pooled analysis

• Convalescent Plasma: JHU/VUMC combined outreach for shared pooled

analysis outreach II. C-DSMB (VUMC)

• HCQ: No outreach
• Convalescent Plasma: VUMC/JHU combined effort for PI outreach for

intermittent data requests for C-DSMB while trials are still accruing

Rather than divide work based on treatment type, divide work based on initiative

Joint Analyses Approach

CHARGE

• Organize and execute a pooled analysis by SARS-CoV-2 trial intervention category (hydroxychloroquine, convalescent plasma,

and other (future))

• The pooled analysis capability will include singe- or multi-site investigations

GOALS

• Organize and execute a pooled data analysis by intervention category with submission of results to clinicaltrials.gov
• Develop database matrix to categorize trials by intervention
• Define primary and secondary endpoint harmonization/standardization
• Harmonize important data dictionary and case report form variables for pooling of analyses
• Create a data analysis plan for combined data sets
• Produce an emergency randomized conrolled trial dat use declaration statement for the data that has been willingly

shared APP APPROACH

• Convene a harmonization working group of statisticians and trialists to develop recommendations for strategic harmonization of

COVID-19 trial information

• Focus efforts on hydroxychloroquine and convalescent plasma trials to convene a demonstration mechanism to harmonize

intervention trials with input from CTSA DSMBs

• Produce a standardized statistical analysis plan and supporting data dictionary for harmonized, individual clinical trials for

hydroxychloroquine, convalescent plasma and other interventions as allowed

• Convene two groups to produce an emergency randomized controlled trial data use declaration for the data that have been

willingly shared. The two groups will be the trialists and statistician contributors and the institutional data users group (health care delivery, health IT, sIRB officials, DSMB members, and other institutional representatives taken from the CTSA network)).

• Register, with a consensus of participating trial PIs, a planned pooled analysis of hydroxychloroquine and convalescent plasma

trials in ClinicalTrials.gov.

HCQ Meeting Attendees – July 8

Adult HCQ

Vanderbilt University (ORCHID) NCT04332991 Bassett Healthcare (COVID MED Trial) NCT04328012 Harvard (PRECISE) NCT04351191 Duke University (Pragmatic Factorial Trial) NCT04335552 University of Utah (HCQ) NCT04342169 Queen's Medical Center, Honolulu (OAHU-COVID 19) NCT04345692 Intermountain (HAHPS) NCT04329832 University of Kentucky (Novel Agents for Treatment) NCT04374019 NYU Langone Health (TEACH) NCT04369742 Washington University (WU352) NCT04341727 University Medical Center, New Orleans (Moderate to Severe Disease) NCT04344444

• Follow-up with HCQ individual teams post meeting to

discuss any hesitations or barriers to data sharing

• Host 2nd Convalescent Plasma study PI meeting
• 2nd Outreach to CTSA teams based on survey results
• Strategic discussions with CTSA PIs to begin with Dr.

Selker (Tufts) and Dr. Lindsell (Vanderbilt)

Pooled Analyses Next Steps

DSMB Background

• Our national clinical research infrastructure has shown a rapid and efficient response to

COVID-19 pandemic

• Multiple, concurrent trials of the same therapeutic (e.g., Convalescent plasma)
• NCATS recognizes the challenges of such rapid initiation and the potential for innovation:
• Small sample sizes may produce inaccurate signal for either efficacy or stopping

criteria due to small sample size

• DSMBs could benefit from study findings of similar therapeutics to more fully

understand the scientific landscape

• Additionally, there’s an essential, ethical responsibility to
• Protect the national trust in research infrastructure as it responds to the COVID-19
• Improve participant safety and maximize scientific benefit in exchange for participant

burden

DSMB coordination (DSMBc) Overview

CHARGE

• Pilot a novel DSMB support plan using visualization and data reporting tools
• Enable synchronized review of multiple studies by a single DSMB entity focused on a specific

therapeutic.

GOALS

• To collect and share DSMB data to enable periodic assessment of safety and efficacy signals across

studies in Convalescent Plasma (CP)

• To collect and analyze data from similar CP trials to provide DSMBs with a larger information set with

which to gain insights into the efficacy and safety of CP

APPROACH

• Initial focus will consist of 3-5 Convalescent Plasma studies.
• Aggregate protocols, statistical plans, outcome variables, and data dictionaries
• Develop statistical graphics and software for coordinating clinical trial reporting for DSMBs

Adult Convalescent Plasma Studies

Adult Convalescent Plasma JHU CSSC-001 NCT04323800 JHU CSSC-004 NCT04373460 VUMC (Pass It On) NCT04362176 SIREN Network (C3PO) NCT04355767

• Follow-up with individual teams regarding any concerns or

hesitations

• Meet with study DSMBs Chairs to define shared data

pathway

• Assemble one or more concrete proposals ("ground rules")

and circulate for feedback, for a vote, or in preparation for a second meeting if necessary

DSMB Next Steps

ResearchMatch

• Supports

recruitment of people that speak English or Spanish

• Matches Spanish

recruitment messages with people selecting Spanish language

• Offers Volunteer

support, education, and engagement in Spanish

Community Engagement Studios

Guidance from CESs regarding clinical trial recruitment to date:

• 1. Be aware of exclusion criteria that limits participation.
• 2. Remove systemic barriers to participation (adding non-traditional times for study visits,

transportation/stipends)

• 3. Develop culturally tailored and translated study materials being carefully not to pander.
• 4. Partner with respected community (national and local)
• rganizations / contacts
• 5. Train study staff (e.g. cultural humility and bias) *Hire study

staff representative of community.

• 6. Disseminate results in real time - full transparency to

continue to establish and gain trust.

EHR-Based Cohort Assessment + Site Selection

5 COVID-19 Expressions of Interest

COVID EOI Expression of Interested Components Response Rate

• Avg. Response Time

ACTIV-1* EHR-based Cohort Assessment + Request for site-investigators 84% 8 Days RAMIC* Request for site-investigators + Protocol Feasibility 39% 11 Days Proning* Request for site-investigators 65% 11 Days COVID Platform Request for site-investigators 44% 14 Days CSSC 001 Request for site-investigators 74% 7 Days

*RIC-Led Expression of Interest

• ACTIV-1 and CSSC-001 Expressions of Interest the CTSA sites were given 1 week to respond (usually

requires 3 weeks)

• Even with this shortened timeframe, sites were still able to respond at a high-rate and in record-breaking

time.

• We believe this is attributed to the established process and CTSA sites recognizability of these requests.

Finding the Right Patient for the Right Trial

REDCap dashboard-daily feed from Epic:

• Lists COVID-19 + patients
• Maps eligibility criteria to currently enrolling trial
• Mapped to co-enrollment
• E-mail and SMS messaging workflows support

English and Spanish

An Un-Meeting on Lifespan and Life Course Research: Integrating Strategies

Susanna McColley, MD

Presentation goals

• Describe the Un-Meeting format, themes, and attendees
• Summarize key themes developed
• Demonstrate how the Un-Meeting outcomes will result in submission
• f a Synergy Paper and development of tools for dissemination

Welcome!

#LifespanUnMeeting

Steering & Planning Committees

Karen Bandeen-Roche

Rashmi Gopal- Srivastava Heidi Hanson Rick Kaskel Rosemarie Rogers Phyllis Mitzen Robert White Christine Stake Susanna McColley Kate Fetherston Judy Giordano Emily Traw Keith Herzog Jaime Ziegler

Attendees

Representatives from 48 CTSA Hubs and IDEA-CTR sites

Attendees

7/22/2020 74

Attendee research interests

7/22/2020 75

Un-Agenda

7:15 – 7:45 Arrival/Coffee 7:45 – 8:15 Breakfast 8:15 – 8:30 Welcome 8:30 – 9:00 Un-Plenary 1 9:00 – 9:45 Idea generation 9:45 – 10:00 Break/Relocate 10:00 – 12:00 Breakouts Topic assignments made during idea generation Each session will last 30 minutes It is encouraged that you switch breakout topics 12:00 – 12:45 Lunch 12:45 – 1:15 Un-Plenary 2 (TL1 Scholars) 1:15 – 1:45 Idea generation 1:45 – 2:00 Break/Relocate 2:00 – 3:00 Breakouts Topic assignments made during idea generation Each session will last 30 minutes It is encouraged that you switch breakout topics 3:00 – 4:00 Report out 4:00 Adjourn

Moments

Major discussion themes

• Data sharing and linking across settings and

sites

• Lifespan and transitions
• Life course
• Intergenerational
• Lifecourse methods
• Toolbox
• Measurement
• Transgenerational research
• Engagement
• Partnership
• Education, communication and resources
• Recruitment and Retention
• Culture and age considerations
• Innovative strategies
• Promoting healthy aging
• Caregiver roles from infancy to older age
• Social determinants of health and rural

health

• “Special populations”
• Terminology and communication
• Funding
• Problem of “fit” within NIH Institutes

Post-meeting survey

Post-Meeting Survey

Ongoing work

• Immediate action: including more trainees and early career faculty

as guest speakers for Integration Across the Lifespan Enterprise Committee meetings

• Ongoing evaluation
• Synergy Paper proposal funded

This happened

Source: coronavirus.jhu.edu July 15,2020

Lifespan Synergy Paper

• Integrating Strategies for lifespan and life course research: the need

for innovation highlighted by a pandemic

• Focus on social and institutional determinants of health
• Propose a structural competency framework to promote inclusion of

underrepresented populations in research using a quality improvement approach

Population, Concept, Context

• Population: People underrepresented in biomedical research
• Concept: Design and implement methods to assess structural barriers, incorporating SDOH and

considerations to specific populations and individuals, to research participation

• Context: While people who are demographically underrepresented in research have unique

individual and group barriers to participation, a holistic framework to evaluate and address these barriers can be used to develop specific strategies for individuals and populations

• Population: People whose data are used in life course research
• Concept: Design and implement methods to assess structural issues in data procurement and

analysis that excludes representative populations from life course studies

• Context: Problems of including representative populations in life course research stem from

both sources of data, including electronic health records, and analytic approaches, which may not report important demographic information.

Eleven hubs, T2-T4

Member CTSA Hub/ organization Scientific discipline Susanna McColley Northwestern University Pediatrics Karen Bandeen-Roche Johns Hopkins University Gerontology; Biostatistics Elizabeth Eckstrom Oregon Health and Science University Geriatrics Frederick Kaskel Albert Einstein College of Medicine Pediatrics Anne Cappola University of Pennsylvania Internal Medicine Dorothy Farrar Edwards University of Wisconsin Gerontology Heidi Hanson University of Utah Epidemiology; Population Health Lainie Friedman Ross University of Chicago Pediatrics; Biomedical Ethics Mark Schleiss University of Minnesota Pediatrics; Materno-fetal infections Dominic Reeds Washington University, St. Louis Geriatrics; Nutritional Science Emerald Rivers (TL1) Johns Hopkins University Nursing; Geriatrics Monica Bianco (recent TL1) Northwestern University Pediatrics Madison LeCroy (TL1) Albert Einstein College of Medicine Epidemiology; Population Health Lindsey Potter (TL1) University of Utah Epidemiology; Population Health Peter Dayan Columbia University Pediatrics Christine Stake Lurie Children’s Hospital Stakeholder Engagement; Sociology, Health Administration

• Q. Eileen Wafford

Galter Library Library Science; Systematic Reviews Phyllis Mitzen Northwestern University community partner, Skyline Village Community engagement of older adults Sheehan Fisher Northwestern University Psychology; parental depression and parent-child interaction

Next steps and getting involved

• Synergy paper writing team monthly meetings, manuscript

submission by June 2021

• Structural competency checklists for modification for use in
• bservational, interventional and life course research
• Dissemination, testing, refinement
• We will be seeking partners!
• Contact information
• SMcColley@luriechildrens.org

Thank you!

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.

CLIC Updates

Martin Zand Deborah Ossip

CLIC Updates: Upcoming Events

• Making a Commitment to Diversity & Inclusion I2I Webinar (Careers metric-CCTR)
• July 29th @ 2:00 PM ET
• Register Now
• CLIC Virtual Tour Part 5: Q&A Session
• August 5th @ 1:00 PM ET
• Register here: https://clic-ctsa.org/events/clic-virtual-tour-part-5
• Building Real Connections: Recruiting Future Clinical Trial Researchers I2I Webinar (Careers metric-CCTR)
• August 27th @ 3:00 PM ET
• Register Now
• Training Applications: Starting with a Strong Foundation I2I Webinar (Careers metric-CCTR)
• September 29th @ 3:00 PM ET
• Register Now
• CLIC Virtual Un-Meeting: Clinical Research in the COVID-era and Beyond
• September 30th
• General Registration Opens: August 17, 2020
• For new updates, visit the Un-Meeting webpage
• Virtual 2020 Fall CTSA Program Meeting
• November 18-20
• For new updates, visit the meeting webpage

Save these dates!

CLIC / NCATS Communication Channels

Sharing Content: CLIC Website

• News (Consortium News & WOW! Factor

stories): clic-ctsa.org/news

• Events: clic-ctsa.org/events
• CLIC Funding opportunities (RFAs):
• Synergy Papers; https://clic-

ctsa.org/collaboration/clic-synergy-papers

• UnMeetings; https://clic-

ctsa.org/collaboration/clic-un-meetings

• CLIC Education & Career Development

Gateway

• Educational tools (Education

Clearinghouse): clic-ctsa.org/education

• Career & training opportunities

(Opportunities Board): https://clic- ctsa.org/opportunities-board

Twitter

• 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

Mike’s Blog

• https://clic-ctsa.org/news/mikes-blog

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: https://ctsa.ncats.nih.gov/cd2h/
• To Join: CD2H Onboarding

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

Reminders

• The next scheduled webinar will be Wednesday, August 26th,

2:00 PM – 3:00 PM Eastern Time.

• Registration URL:

https://rochester.zoom.us/webinar/register/WN_Bz2g- rQqTV6gJLI614aXgA

• ctsa_program_webinar@clic-ctsa.org
• https://clic-ctsa.org/groups/ctsa-program-group