CTSA Ansible – May 2021

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THE SPOTLIGHT | WHAT’S NEW | GET INVOLVED | CONSORTIUM CORNER

Mike’s Blog May 2021

A Note from Joni

Guest Blog by Dr. Joni L. Rutter, NCATS Acting Director

Greetings!

It is my pleasure to be a guest on Mike’s Blog this month. While I have not yet met some of you, I hope this can serve as an introduction in my new capacity as Acting Director of the National Center for Advancing Translational Sciences.

It has just been a few weeks since Dr. Austin’s departure, and you may be wondering how this leadership change could affect you. I can assure you that the CTSA Program will not skip a beat. I have been and remain a committed super fan of the CTSA Program! In fact, I could not be more excited about the CTSA program’s future. I have been deeply involved in the N3C and look forward to translating that exceptional “can-do-ness” energy to other areas of the CTSA Program as we continue to approach many critical clinical research and translational science endeavors. To Access Full Blog – Click Here.

THE SPOTLIGHT


CTSA Program Hubs Will Help Implement the ACTIV-6 Clinical Trial

The National Institutes of Health will fund a large, randomized, placebo controlled Phase 3 clinical trial to test several existing prescription and over-the-counter medications for people to self-administer to treat symptoms of COVID-19. The trial is part of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership and overseen by NCATS.
The Duke Clinical Research Institute, Durham, North Carolina, an NCATS-funded Clinical and Translational Science Awards (CTSA) Program hub, will serve as the clinical coordinating center, and the Vanderbilt Institute for Clinical and Translational Research CTSA Program hub will serve as the trial’s data coordinating center. Enrollment will focus on communities that are significantly affected by COVID-19 but lack access to major academic medical centers, where large clinical trials usually take place.

WHAT’S NEW


– UPCOMING EVENTS –

NEW: NCATS Advisory Council (June 10-11, 2021)

Several CTSA concepts will be presented: https://ncats.nih.gov/advisory/council.

Un-Meeting: Exploring the Inclusion of Community Hospitals in Clinical Research

Save the date! This NCATS Un-Meeting will focus on the successful outreach and recruitment of community hospital participants into clinical trials prior to and during the COVID-19 pandemic. What lessons were learned and how can these strategies be implemented for future clinical trials?

Registration and details coming soon.


NEW: Virtual Workshop: Enhancing the Participation of Research Investigators in the Biomedical Workforce, May 18-20, 2021

In partnership with the UCLA Clinical and Translational Science Institute (CTSI) and Charles R. Dew University of Medicine and Science (CDU) Urban Health Institute, the National Institute of Allergy and Infectious Diseases (NIAID) is hosting their regional research funding workshop with Charles R. Drew University of Medicine and Science (CDU) and UCLA titled “Enhancing the Participation of Research Investigators in the Biomedical Workforce.” This three-day workshop May 18-20, 2021 is free and open to pre and post-doctoral fellows, clinician-scientists, as well as early-stage and mid-career research investigators at any institution.

– UPDATES AND REMINDERS FROM NIH –

NEW: Funding Opportunity Announcement (FOA) and Accompanying Notice of Special Interest (NOSI): Clinical and Translational Science Award (CTSA) Consortium-Wide Centers: Resources for Rapid Demonstration and Dissemination (C3-R2D2) – Health Informatics

NCATS will support applications for Clinical and Translational Science Award (CTSA) Program consortium-wide resource centers that will rapidly demonstrate and disseminate innovative resources (to include capabilities) that have demonstrated impact at a local or national level to the wider consortium. Only applications responding to a NOSI will be allowed to apply to this FOA.Due date for NOT-TR-21-025: June 21, 2021. More information onPAR-21-203andNOT-TR-21-025.

NEW: Notice of Intent to Publish Research Opportunity Announcements for the NIH Post-Acute Sequelae of SARS-CoV-2 Infection Initiative: PASC Data Repositories and Mobile Health Platform

NIH plans to publish two additional ROAs in support of the PASC Initiative, one on PASC Data Repositories and one on a Mobile Health Platform. The solicited research will improve understanding of and develop strategies to prevent and treat post-acute manifestations of SARS-CoV-2 infection across the lifespan. Publication of the ROAs is expected in May 2021. Projects will be funded utilizing NIH’s Other Transaction Authority (OTA), which offers flexibility and the ability to engage partners in collaborative innovation and problem solving. Initial awards are anticipated to be made in June 2021. We will issue broad notification to the community when the ROAs are published. Please direct all inquiries to: NHLBI_OTA@mail.nih.gov.

NEW: Funding Opportunity Announcements for RADx-UP Phase II

  • RFA-OD-21-008 Emergency Awards: Community-engaged COVID-19 Testing Interventions among Underserved and Vulnerable Populations- RADx-UP Phase II (U01, Clinical Trial Optional). More information.
  • RFA-OD-21-009 – Emergency Award: RADx-UP – Social, Ethical, and Behavioral Implications (SEBI) Research on Disparities in COVID-19 Testing among Underserved and Vulnerable Populations (U01 Clinical Trials Optional). More information.
  • NOT-OD-21-103 – Notice of Special Interest (NOSI): Emergency Competitive Revisions for NIH Grants to Add or Expand Community-engaged COVID-19 Testing Interventions among Underserved and Vulnerable Populations – RADx-UP Phase II (Emergency Supplement- Clinical Trial Optional). More information.
  • NOT-OD-21-101– Notice of Special Interest (NOSI): Administrative Supplements for Rapid Acceleration of Diagnostics-Underserved Populations (RADx-UP) Phase I Projects to Address Vaccine Hesitancy and Uptake. More information.

NEW: Publication of the Revised NIH Grants Policy Statement (Rev. April 2021) for Fiscal Year 2021 (NOT-OD-21-107)

The updated FY 2021 version of the NIH Grants Policy Statement (GPS) applies to all NIH grants and cooperative agreements with budget periods beginning on or after October 1, 2020. A table summarizing the significant changes implemented with this revision is available on the GPS webpage.

NEW: Expanding Requirement for eRA Commons IDs to All Senior/Key Personnel (NOT-OD-21-109)

All individuals listed on the Research & Related Senior/Key Person Profile (Expanded) form must have an eRA Commons ID, effective for grant application due dates on or after January 25, 2022.

REMINDER: Upcoming Changes to the Biographical Sketch and Other Support Format Page (NOT-OD-21-073) required for all applications and RPPRs submitted for due dates on or after May 25, 2021

OPERA has recently published Guide Notice NOT-OD-21-073, Upcoming Changes to the Biographical Sketch and Other Support Format Page. Updated forms and instructions will be required for all applications and RPPRs submitted for due dates on or after May 25, 2021. Updated Biosketch resources, including FAQs and sample Biosketch format pages can be found here. Updated Other Support resources, including FAQs and sample Other Support format pages can be found here.

REMINDER: Non-Compliant Publications in RPPRs

Publications not compliant with the NIH Public Access Policy will cause a delay in review and processing of the applicable Notice of Grant Award.

Blog from NIH Office of Extramural Research: Why Properly Acknowledging NIH Support in Your Paper is Important

Imagine this scenario. In the hustle to publish a paper, you accidently forgot to cite the underlying NIH support. Or, the opposite, you opt to include that other grant in the acknowledgments that did not have anything to do with the work. No problem, right? Well, it could be.

– CTSA PROGRAM NEWS AND UPDATES –

Working Group Proposals Open

The CTSA Program Working Groups (WGs) consider and develop solutions around a specific clinical and translational science issue. Working Groups that are APPROVED by CTSA Program Steering Committee will be supported by CLIC. Groups/Individuals interested in forming a WG are required to propose and deliver well-defined projects or deliverables that fill identified translational gaps and/or further the CTSA Program objectives in high priority areas in clinical and translational science.

Proposals due June 1. (Please note: deadline was moved because of the Memorial Day holiday)

More information >


Introduction to CM-PRISM Webinar

Common Metrics – Program Results to Improve Strategic Management, aka CM-PRISM, is the new data reporting software platform for CTSA Program hubs to report their annual Common Metrics data and narratives. This new platform was built in REDCap, which is familiar software to many hubs across the consortium. This new platform has the flexibility to accommodate multiple users from each hub and to ease the burden of data entry. The goal of this new platform is to increase the consistency and comparability of hub data across the consortium. CM-PRISM has been designed to support the updates made by the Informatics and Careers Metric Quality Improvement committees. Register for CLIC’s “Introduction to CM-PRISM” webinar on Monday, May 17 at 3 pm ET.

Another N3C Published Preprint

For the past year, researchers have been pursuing possibilities for the repurposing of existing drugs that can effectively disrupt COVID-19 disease processes. Electronic health record (EHR) data from the N3C Data Enclave were used to produce a recent preprint published in medRxiv on April 6, 2021 titled Drug repositioning candidates identified using in-silico quasi-quantum molecular simulation demonstrate reduced COVID-19 mortality in 1.5M patient records.

– TOOLS AND RESOURCES –

The CLIC Career Development Community has launched!

This is an interactive space available to the CTSA Program and greater translational science communities where individuals can collaborate, network and share ideas with their peers. There are three focus areas for KL2 scholars, TL1 trainees and clinical research professionals. Each focus area includes a message board, community content feed and searchable community member list to foster communication across the consortium.

UPDATE: Community Engagement Alliance (CEAL) Against COVID-19 Disparities

The NIH Community Engagement Alliance (CEAL) Against COVID-19 Disparities focuses on addressing misinformation around COVID-19, engaging trusted partners and messengers in the delivery of accurate information, and educating communities on the importance of inclusion in clinical research to overcome COVID-19. The CEAL website includes resources that can be shared with your communities – now available in both English and Spanish – on vaccines, diversity and inclusion, clinical trials, and COVID-19 basics. Popular resources to explore include up-to-date information, infographics, videos, toolkits, social media and key digital links to help keep your communities informed.

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