By bringing together experts with complementary skills, knowledge and experience, NCATS helps projects cut through operational roadblocks to contribute to new knowledge about COVID-19 and the virus that causes it. Read about a few of the collaborative efforts supported by NCATS that are enabling the rapid launch of clinical studies, the translation of data into knowledge and possible new solutions for further exploration:
- A Network Approach for Understanding COVID-19 and Rare Diseases
- Leveraging Existing Partnerships to Build a National Data Analytics Platform
- Forming New Collaborations to Jump-Start and Optimize Studies
- Accelerating Clinical Trial Start-Up
- Harnessing the Power of Crowdsourcing to Share Novel Uses for Repurposed Drugs
- Building on Community Relationships to Increase Participation by Underserved and Vulnerable Populations in Research
- Partnering with Industry to Speed Development of Promising Treatments
A Network Approach for Understanding COVID-19 and Rare Diseases
The NCATS-led Rare Diseases Clinical Research Network (RDCRN) consists of 20 collaborative clinical research teams who partner with patient groups to study how rare diseases progress and to develop better ways to diagnose and treat them. This close partnership enabled RDCRN researchers and clinicians to recognize that many people with rare diseases faced new challenges from the COVID-19 pandemic, from reduced access to needed medical care to possible heightened anxiety and stress. They launched an online survey to find out how the COVID-19 pandemic is impacting individuals with rare diseases, their families and their caregivers. Results of the survey, which will remain open into the fall, will help researchers shed light on the needs of people with rare diseases during the COVID-19 pandemic and other potential health crises, in addition to informing future research efforts. Learn more about the survey.
Leveraging Existing Partnerships to Build a National Data Analytics Platform
Vast amounts of data are being generated that could be used to advance research efforts focused on COVID-19. But the datasets often become too large to share, and the networks for data management are so dissimilar that they cannot be combined easily. Making data more meaningful, open and accessible is a key goal in NCATS’ efforts to improve translational science and advance research across many diseases. NCATS, in partnership with the Clinical and Translational Science Awards (CTSA) Program hubs and the National Center for Data to Health (CD2H), launched an effort to build a centralized national data resource for studying COVID-19 and identifying potential treatments. The National COVID Cohort Collaborative, or N3C, is building an analytics platform to systematically collect clinical, laboratory and diagnostic data from different sources and harmonize it. Researchers can access the N3C Data Enclave analytics platform to accelerate COVID-19 research and clinical care. If successful, this approach may help answer other research questions and serve as a model for addressing future public health emergencies. Learn more about the N3C and applying for data access.
Forming New Collaborations to Jump-Start and Optimize Studies
Scientists at NCATS laboratories focus on key obstacles and inefficiencies in the translational process, overcoming bottlenecks that slow the development of new treatments for patients. They help collaborators do this, too. A prime example is a new NIH study: a serosurvey to analyze blood samples and quantify the number of undetected coronavirus cases — information that could guide the COVID-19 response. NCATS translational scientist Matt Hall, Ph.D., who had originally proposed the idea, pulled together a new collaborative team of researchers from across the NIH. Each colleague brought a different set of domain expertise and resources that enabled the team to begin recruiting study volunteers in less than a month. NCATS’ role has since expanded to include optimizing both the test that will be used to analyze the blood samples and the data collection efforts through a new data dashboard. Read more about the study.
Watch this video to learn how the NIH study to measure undetected COVID-19 cases came together:
A version of this video with audio description is in development and will be posted as soon as it is available.
Accelerating Clinical Trial Start-Up
- NCATS’ Clinical and Translational Science Awards (CTSA) Program brings together academic medical centers from around the country to innovate locally, regionally and nationally on the myriad scientific and operational roadblocks currently limiting clinical translation. Having an established collaborative structure in place to enhance operational and scientific efficiency (as well as safety) is critical during the COVID-19 pandemic. For example, a CTSA Program collaboration between the Indiana Clinical and Translational Sciences Institute (CTSI) and the South Carolina Clinical and Translational Research (SCTR) Institute resulted in a study to determine if health care providers at a hospital have been exposed to the virus that causes COVID-19. The SCTR launched a fast-track approval process, refined the protocol and implemented the study within 15 days. Currently, all 440 participants have been screened and enrolled, with future participants currently on a wait list. Read more about the collaboration between the CTSI and the SCTR.
- As the COVID-19 pandemic rapidly evolved and underscored the urgency to get trials underway faster, NCATS’ Trial Innovation Network (TIN) and CTSA Program hubs stepped up to ensure effective support and rapid implementation of clinical research studies aimed to treat or understand various aspects of COVID-19. For example, the Johns Hopkins University Trial Innovation Center is supporting the planning and partial implementation of a suite of trials testing convalescent plasma to prevent or treat COVID-19. The team believes using plasma from patients who have recovered from COVID-19 infection could provide immediate immunity to the most at-risk individuals to protect them from infection or help infected individuals recover. Read more about this clinical trial.
- Rigorous clinical trials can deliver strong evidence on whether COVID-19 treatments are safe and effective. The CTSA Program, including its Trial Innovation Network, is playing a key role in rapidly expanding enrollment in two randomized, placebo-controlled trials evaluating convalescent plasma as a treatment for people hospitalized with COVID-19. The trials demonstrate a nimble and coordinated response to the nation’s public health need to bring safe, effective COVID-19 therapies to patients sooner. Read more about these clinical trials.
- NCATS is coordinating and overseeing an adaptive Phase 3 clinical trial to evaluate the safety and efficacy of three immune modulator drugs in hospitalized adults with COVID-19. The CTSA Program, with its innovation in conducting clinical trials, extensive capacity and broad geographical reach, is playing a key role in rapidly implementing the trial. The trial, known as ACTIV-1 Immune Modulators, is part of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership. It aims to determine if the therapeutics can restore balance to an overactive immune system and, as a result, reduce the need for ventilators and shorten hospital stays. Read more about the large-scale clinical trial or watch NCATS Director Christopher P. Austin, M.D., discuss the trial with NIH Director Francis Collins, M.D., Ph.D.
Harnessing the Power of Crowdsourcing to Share Novel Uses for Repurposed Drugs
Created through a collaboration between the U.S. Food and Drug Administration (FDA) and NCATS, CURE ID enables the crowdsourcing of medical information from health care professionals to facilitate the development of new treatments using repurposed drugs for difficult-to-treat infectious diseases. CURE ID, which is accessible through a website, smartphone or other mobile device, was recently updated to boost the platforms effectiveness to address the COVID-19 pandemic. The app, which was developed with NCATS’ support, includes information on most clinical trials submitted to clinicaltrials.gov for COVID-19 drugs, biologics and vaccines, which is frequently updated. Other available information includes relevant journal articles, news articles and events. Building off the CURE ID platform, the Critical Path Institute launched the CURE Drug Repurposing Collaboratory (CDRC), a public-private partnership funded by the FDA, in collaboration with NCATS, to accelerate the identification of effective treatments and further drug development. The CDRC will demonstrate how data shared from clinicians in real-time can be used to inform ongoing and future clinical trials and potentially drug labeling. Download the CURE ID app from a mobile app store.
Building on Community Relationships to Increase Participation by Underserved and Vulnerable Populations in Research
Communities of color account for more than half of all reported COVID-19 cases in the United States and historically are underrepresented in clinical research. The Clinical and Translational Science Awards (CTSA) Program hubs have built trusting relationships with these communities by including them in research design and clinical study participation and by disseminating study outcomes to the communities. These ongoing efforts enabled the hubs to pivot rapidly to support two new NIH-wide initiatives focused on addressing health disparities exacerbated by COVID-19. The NIH Community Engagement Alliance (CEAL) Against COVID-19 Disparities is leveraging CTSA Program community engagement resources to promote and facilitate the inclusion and participation of underrepresented communities in COVID-19 vaccine and therapeutic clinical trials. Similarly, the Rapid Acceleration of Diagnostics for Underserved Populations (RADx-UP) program, which is focused on expanding COVID-19 testing for underserved communities, is utilizing CTSA Program Community and Collaboration Cores to connect researchers and trainees with community-engaged research activities. This work will help identify community needs and inform research priorities. In addition, six CTSA Program hubs have received RADx-UP funding. Learn more about CEAL and RADx-UP.
Partnering with Industry to Speed Development of Promising Treatments
When the COVID-19 pandemic began, no approved therapeutics or vaccines were available to counteract SARS-CoV-2. NIH responded swiftly with the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) initiative, a public-private partnership to coordinate development of the most promising treatments and vaccines. Alongside industry partners, NCATS has a lead role in a range of ACTIV efforts. The preclinical work focuses on the evaluation of therapeutic candidates to identify potential treatments. Two research papers from the ACTIV Preclinical Working Group offer new tools to speed drug discovery and testing. In the first paper, researchers provide a blueprint for rethinking the traditional sequential drug development approach. They propose streamlined pathways and criteria to identify the most promising therapeutic agents for COVID-19 and move them into human trials rapidly and safely. The second paper summarizes the latest guidance and insights on animal models for preclinical testing of COVID-19 vaccines and therapeutics. The review complements animal model data that are updated regularly by the working group and researchers on the NCATS OpenData Portal. In addition to these efforts, NCATS is coordinating and overseeing the ACTIV-1 Immune Modulators clinical trial to determine whether immune modulator drugs can restore balance to an overactive immune system in hospitalized adults with COVID-19.
Learn more: See how NCATS-supported platform approaches pivot to COVID-19 efforts.