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Mike's Blog - August 2020

Community Engagement in the COVID era is the CTSA version of All Hands-on Deck

As the COVID-19 pandemic continues to rampage across the globe and now some nations previously lauded for their infection control practice are seeing a resurgence, along with emerging science suggesting not only a very low infectious dose, but also efficient asymptomatic transmission, the focus on COVID interventions both treatment and prevention is heating up.

Across the US, several large-scale vaccines trials as well as multiple inpatient and outpatient treatment trials are beginning to enroll. At the same time, other emerging data has painfully demonstrated limitations in our ability to diagnose COVID and NIH has embarked on an ambitious design to test novel devices as well as strategies to identify COVID-19 cases more rapidly. More recently, published evidence has called into questions our traditional concept of immunity (typically based on neutralizing antibody titers) which will further complicate our ability to assess the future public health impact of both vaccines and recovered cases.  Continue Reading

THE SPOTLIGHT


EHR COVID-19 DREAM Challenge

Launched earlier this year in response to the coronavirus pandemic, the EHR COVID-19 DREAM Challenge is designed to use electronic health record (EHR) data to to answer the question: Of patients who had at least one encounter/visit at University of Washington Medicine and who had a COVID-19 test, can we predict who tested positive? Due to the importance and emergent need for a better understanding of the virus and for the development of patient-specific risk scores and early warning tools, the Center for Data to Health (CD2H) developed a platform to support analytic and machine learning hypotheses on clinical data to rapidly discover and implement approaches for care

The COVID EHR dataset was updated on August 6th with additional patient data from UW’s EHR. (Models previously submitted still function in the updated infrastructure.) Several useful resources, including a synthetic dataset and a data dictionary, are available for scientific collaboration. The data will be a valuable part of the National COVID Cohort Collaborative (N3C) Enclave that is scheduled to open for community research this summer. The DREAM Challenge’s goal is to make biomedical research more transparent, more reproducible, and more accessible to a broader audience of scientists. CD2H and N3C thank all participants for their interest in this continuous benchmark project!


WHAT'S NEW


Common Metrics - Insights to Inspire Series

The Insights from the hubs have now all been posted to the CLIC website. This year's series of blogs focused on the Careers in Clinical and Translational Research metric. Be sure to read all the stories from this year or last. The associated webinars are scheduled through November and will present the successes of the hubs in the Careers metric. You can find the list of webinars here or access past webinars by going to the CM Webinars page (login required). You can read about all Common Metrics activities from the Common Metrics page on the CLIC website!  Additional stories from hubs are available on our website. We also encourage you to share your hub’s insights.

Fall 2020 Virtual CTSA Program Meeting

Reminder - 2020 Fall Program Meeting will be held virtually on November 18 – 20, 2020. Virtual registration details coming soon!

2020 NCATS Responsive Un-Meeting - Registration Opens August 17, 2020

This NCATS “rapid-response” Un-Meeting will encourage discussions around the changes encountered in the area of clinical and translational research resulting from the COVID pandemic. Other potential topics include Identifying clinical research trial design opportunities as a unified network in the post-COVID clinical era? What does training look like? What do remote trials look like? What is the impact on recruitment? Furthermore, what is the role of CTSA Program in clinical research post-COVID.  We look forward to seeing you in the ether!

Human Subjects Research Updates

We recently updated the New Projects Human Subject Research (HSR) submission guidelines(updated July 8, 2020). Current HSR study risk categories and process types are summarized in the above table. As always, please follow the instructions provided in the guidelines and include all required information and documents from the Addendum and Instructions, according to the research category and process type.  For questions/comments about the process please email the DOPA mailbox at NCATSDOPAinquiry@mail.nih.gov.  For additional questions please contact your designated NCATS Program Official.

CTSA Competitive Revision Awards (PAR-19-337)

The purpose of this FOA is to solicit competitive revision (formerly known as competitive supplement) applications from awardees with active Clinical and Translational Science Award (CTSA) Program hub awards (UL1) to support the demonstration, and/or dissemination, and/or implementation of highly innovative and impactful translational science projects that address the goals of the CTSA Program and are beyond the original scope of the approved parent project. The July CTSA Program Webinar included an informational presentation about this FOA. The next application due date is September 25, 2020. For more information and complete instructions please follow PAR-19-337.

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