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Mike's Blog November 2020

Catalyzing the CTSA “Power” to Serve the Vulnerable and Underserved

As COVID-19 continues as a top priority at all levels of our research enterprise, finding strategies to contain the spread of the virus and better treat the disease and its complications remains paramount. RADx-UP is an NIH initiative to support the development of community-engaged projects across the United States to assess and expand COVID-19 testing for underserved and/or vulnerable populations, which include health disparity populations, particularly African Americans and American Indians/Alaska Natives; those in nursing homes, jails, rural areas, or underserved urban areas; pregnant women; and the homeless. Read More


ACTIV-1 Immune Modulators Trial “Open to Enrollment”

Last month, NIH launched an adaptive Phase 3 clinical trial to evaluate the safety and efficacy of three immune modulator drugs in hospitalized adults with COVID-19. This is a randomized, parallel assignment, triple-blinded clinical trial of 3 immunomodulators - infliximab (REMICADE), abatacept (ORENCIA), and Cenicriviroc (CVC), in patients hospitalized for COVID-19. The trial utilizes an adaptive master protocol design and, as discussed in last month’s Mike’s Blog, NCATS through its Trial Innovation Network (TIN) is involved in the coordination, implementation and oversight of the trial. The study will be conducted at CTSA consortium sites and additional non-CTSA sites, including multiple international sites across four countries and is registered in under NCT04593940. Recently, NIH Director Dr. Francis Collins and NCATS Director Dr. Chris Austin discussed ACTIV-1 in an interactive Q&A session posted on YouTube.


Harnessing CTSA Community Engagement efforts against COVID-19

The Community Engagement Alliance (CEAL) Against COVID-19 Disparities initiative supports community outreach and engagement efforts in communities disproportionately affected by the COVID-19 pandemic. CEAL is an NIH-wide effort led by the National Institute on Minority Health and Health Disparities (NIMHD) and the National Heart, Lung, and Blood Institute (NHLBI).The goal is to leverage established relationships between researchers and local community leaders to help reach communities that might not have access to COVID-19 clinical research sites.
NCATS is playing an important role and as Dr. Austin mentioned in his recent Director’s Corner, “CEAL is leveraging the CTSA Program hubs’ strong community partnerships and long-standing community-engaged research efforts in 11 states to facilitate the inclusion and participation of ethnic and racial minority communities in COVID-19 vaccine and therapeutic clinical trials.” This is another example of how CTSAs are playing an active and important role in fighting this pandemic.

2020 NIH Rural Health Seminar: Challenges in the Era of COVID-19

Join the National Institute on Minority Health and Health Disparities (NIMHD) and the National Center for Advancing Translational Sciences (NCATS) for the 2020 NIH Rural Health Seminar: Challenges in the Era of COVID-19. The seminar will bring together researchers, medical practitioners and others to explore topics in rural health. Learn and explore the impact of COVID-19 on rural populations, systems and workforce issues, and community engagement to respond to the pandemic. Date: Thursday, November 19, 2020 Time: 1p.m.–5 p.m. ET.

Translational Science Interagency (NCATS/FDA) Fellowship

The Translational Science Interagency Fellowship (TSIF) program is jointly sponsored by NCATS and the U.S. Food and Drug Administration (FDA) and aims to provide training in both translational science and regulatory science. This is a three-year postdoctoral program that combines training at the FDA and within the NCATS Intramural Research Program. Applications being accepted now. For more information about eligibility requirements and how to apply please follow Applications are due January 15, 2021. 

Also, NCATS Intramural Research Program recently published a paper focused on the intramural training environment and early outcomes of alumni from these training programs.

NIH Loan Repayment Programs (LRPs)

The NIH Loan Repayment Programs (LRPs) are a set of programs established by Congress and designed to recruit and retain highly qualified health professionals into biomedical or biobehavioral research careers. NCATS  participates in the Clinical Research, Pediatric Research and Health Disparity Research LRPs. Online Application Period is from Sept 1, 2020 to Nov 20, 2020. Educational loan repayment maximum up to $100K over 2 years, depending on debt level.  Our NCATS point of contact is: David Wilde, MD, PhD.

N3C Mobilizes Patient Data to Study COVID-19: Featuring the Immunosuppressed/Compromised & Diabetes/Obesity Domain Teams

Individuals with compromised or suppressed immune systems (ISC) are considered high-risk for developing severe or life-threatening symptoms due to viral infections; however, little is known about the impact of COVID-19 on ISC populations. The ISC population is diverse in the levels, types, and durations of immunosuppression, including individuals with autoimmune diseases, immune compromising medical conditions, such as HIV, and solid organ transplant (SOT) patients that require therapeutics to suppress rejection responses against the allograft. Our team is requesting access to the Level 2 de-identified data to gain a better understanding of how COVID-19 affects ISC sub-populations. Our initial research will focus on a subset of target populations: persons with HIV (PWH), SOT, and autoimmune disorders including skin diseases such as atopic dermatitis and eczema. For each of these, we will ask the following questions: 1) What is the incidence of COVID-19 infection in the target population, and is it higher than in those without the ISC conditions?; 2) Is there an association between the target population and severity of COVID-19 infection?; 3) Is there a difference in severity of COVID-19 infection depending on the type/class of immunosuppressive drug used across the target population?; 4) What is the outcome of the target population after treatment for COVID-19 within those that are hospitalized (e.g. ventilator, LOS, death)? Through this research, we will gain a better understanding of how various types, levels, and durations of immunosuppression or compromise contribute towards ISC patient outcomes upon COVID-19 infection.

Apply to Host a CLIC Supported Virtual Un-Meeting

CLIC is currently accepting applications from CTSA Program hubs* interested in holding their own virtual Un-Meeting on a topic of their choice. The selected application will receive CLIC support in hosting their virtual Un-Meeting in early 2021, including planning guidance, high level coordination and materials from CLIC, as well as the necessary resources to virtually host the meeting. Application Deadline is December 15, 2020.


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