CTSA Ansible- July 2021

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

Mike’s Blog July 2021

Expanding Options for COVID Interventions

Although COVID-19 infections are decreasing and vaccinations among the adult population hover around 50%, COVID-19 is not quite yet in our rear-view mirror due to a combination of uncertainty regarding durability of immunity conferred by either vaccination or natural infection as well as emerging viral variants of concern. The FDA has authorized emergency use of intravenous monoclonal antibodies in the outpatient setting for patients with mild to moderate COVID-19 at high risk for severe disease, as well as several treatments for hospitalized patients with moderate to severe COVID-19, including anti-viral drug remdesivir, anti-inflammatory baricitinib, and corticosteroids.

For those who become infected with COVID-19 but are not sick enough to be hospitalized, reducing the duration and severity of COVID-19 symptoms with drugs already approved by the U.S. Food and Drug Administration (FDA) could fill an important gap, especially if a reduction in symptoms also reduces potential transmission. More than 80% of COVID-19 cases are diagnosed in outpatient care settings. Making repurposed prescription and over-the-counter medications available that people can self-administer at home can potentially deliver evidence-based COVID-19 treatments sooner to patients in need. To Access Full Blog – Click Here

THE SPOTLIGHT

Journal of Clinical and Translational Sciences Special Issue

The special issue of the Journal of Clinical and Translational Science, “Re-engineering the Clinical Research Enterprise in Response to COVID-19: The CTSA Experience,” published in June 2021, highlights the Clinical and Translational Science Awards’ (CTSA) tremendous local, regional, and national response to the COVID-19 pandemic. This unique compendium of 14 articles demonstrates the CTSA Program in action, pivoting to address COVID-19’s particular challenge to our nation’s biomedical research enterprise with a multifaceted translational approach.

As reflected in this collection and in the accompanying Foreword, the CTSA experience during the height of the COVID-19 pandemic exemplifies the collective capacity of the CTSAs as a transformational national network. Among the translational approaches discussed are: the use of telemedicine and remote technologies for patient care and clinical research; adaptation of processes involved with the institutional review board and informed consent; provision of support to clinicians navigating access to COVID-19 therapies; leveraging infrastructure to rapidly create a clinical data repository and biorepositories; engagement with community partners; and reexamination of root causes of health inequities in light of COVID-19. The articles touch upon virtually all the areas of focus of the CTSAs, capturing some of the many ways that the CTSAs have led the way in enhancing the translational process, catalyzing innovation in processes, research tools, and training to meet patient needs. These lessons learned and best practices shared are part of a new clinical and translational research landscape and provide reminders of what the CTSA program has done and can do to continue to address COVID-19 and future public health emergencies.

Explore the special issue here.

Share on Twitter

WHAT’S NEW

UPDATES AND REMINDERS FROM NIH

NCATS Council Meeting

The NCATS Council Meeting took place on June 10-11, 2021. Videocast of Day 1 and Day 2are available. Clearance of the following CTSA Concepts were all approved:

Clinical and Translational Science Award: Hub, UM1 mechanism
Specialized Innovation Programs: RC2 mechanism
Institutional Training: T32 (post-doc), T32 (pre-doc)
Institutional Career Development: K12
Research Education: R25 (short-term research experiences)

A Technical Assistance Webinar is planned after the release of the funding opportunities.

Upcoming Event: Food Insecurity, Neighborhood Food Environment & Nutrition Health Disparities: State of the Science

Sept. 21-23, 2021, 12:30-5:30 p.m. EDT. More information and Registration.

NEW: Federal Financial Reports

Updated Process for Submission of Federal Financial Reports for Closed Payment Management System Subaccounts. More information on NOT-OD-21-128.

NIH Final Federal Financial Reports (FFRs) will be converted to Interim Annual Reports in the Payment Management System. More information on NOT-OD-21-138.

NEW: Early Detection Research Network (EDRN) Funding Opportunity Announcements (FOAs) have been published.

Due Date September 9, 2021; letters of intent are due 30 days prior to the application due date.

EDRN Biomarker Characterization Centers (U2C): More information on RFA-CA-21-035.

EDRN Clinical Validation Centers (U01): More information on RFA-CA-21-033.

EDRN Data Management and Coordinating Center (U24): More information on RFA-CA-21-034.

Notice of Pre-Application Webinar for the “Early Detection Research Network” Program: RFA-CA-21-033, RFA-CA-21-034, and RFA-CA-21-035 at times listed in the notice on July 12, 2021, and August 9, 2021. More information on NOT-CA-21-088.

REMINDER: NIH is implementing new RPPR alerts to help grantees be compliant with the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information

(NOT-OD-16-149). This policy includes registering trials and submitting trial results at ClinicalTrials.gov in a timely manner.

REMINDER: Notice of Change to Key Dates for PAR-18-940 (CTSA U54).

The August 15, 2021 receipt date has been moved to July 15, 2021. More information on NOT-TR-20-036.

REMINDER: Non-Compliant Publications in RPPRs

Publications not compliant with the NIH Public Access Policy will cause a delay in the review and processing of the applicable Notice of Grant Award. NIH cannot issue restricted awards until September 15th.

REMINDER: Implementation of Changes to the Biographical Sketch and Other Support Format Page (NOT-OD-21-110)

Applications, Just-in-Time, and RPPR are expected as of May 25, 2021; required on or after January 25, 2022. More information on NOT-OD-21-110. Questions: nihosbiosketch@nih.gov.

REMINDER: 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. More information on NOT-OD-21-109

CTSA PROGRAM NEWS AND UPDATES

Insights to Inspire 2021, Informatics: The Journey to Interoperability

Data interoperability, the ability to share and use data across systems and institutions, is critical for the advancement of translational science. The Center for Leading Innovation and Collaboration (CLIC) new webcast series “Insights to Inspire 2021, Informatics: The Journey to Interoperability” shares how institutions can move toward data interoperability.

The webcasts are divided into two parts: The first five provide foundational knowledge about informatics, while the next seven dive deeper into specific topics related to interoperability. All webcasts are now available on the CLIC website.