The FDA is partnering with the Critical Path Institute (C-Path) and the National Center for Advancing Translational Sciences (NCATS), part of the National Institutes of Health (NIH), on the CURE Drug Repurposing Collaboratory (CDRC). CDRC will provide a forum for the exchange of clinical practice data to inform potential new uses of existing drugs for areas of high unmet medical need, advancing research in these areas. CDRC will focus on capturing relevant real-world clinical outcome data through the FDA-NCATS CURE ID platform. In a pilot project focused on COVID-19, CDRC will use data collected via the CURE ID platform to aggregate global clinician treatment experiences to identify existing drugs that demonstrate possible treatment approaches that should be studied further.
FDA recognizes that many stakeholders are interested in designing and producing 3D printed devices during the COVID-19 public health emergency. We are also aware that stakeholders often do not know what device designs to choose or how much to print. In light of this and as part of our effort to protect the public to the extent possible, FDA is facilitating information-sharing regarding the use of 3D printing and other advanced manufacturing technologies in the context of personal protective equipment (PPE) and other medical device parts. To this end, the FDA entered a Memorandum of Understanding (MoU) with the Department of Veterans Affairs (VA) Innovation Ecosystem and the National Institutes of Health (NIH) 3D Print Exchange, to share data, and coordinate on open-source medical products for the COVID-19 response. These agencies are also working closely with America Makes, to provide resources that will connect health care providers and 3D printing organizations.
For more information: 3D Printing in FDA's Rapid Response to COVID-19
The FDA is applying data from diverse sources to inform its response to COVID-19 and this work is being done in collaboration with partners in the U.S. government, academia and industry. Examples include:
- The FDA has entered into an agreement with Aetion to collaborate on advanced analytical techniques to answer urgent COVID-19 research questions. The FDA and Aetion aim to answer questions about the use of diagnostics and medications in the pandemic, and risk factors for COVID-19-related complications in different patient populations.
- The rapid assessment of inpatient treatments has emerged as particularly critical for effective COVID-19 care, because the majority of life-threatening cases of COVID-19 are treated in inpatient settings. An FDA-funded extramural research project aims to develop a system of studies for the rapid assessment of the safety and effectiveness of COVID-19 inpatient medical countermeasures using real-world evidence (RWE).
- The FDA is participating in the COVID-19 Diagnostics Evidence Accelerator, a multi-stakeholder collaborative project to advance the development of diagnostics. The Diagnostics Evidence Accelerator is organized by the Reagan-Udall Foundation for the FDA in collaboration with Friends of Cancer Research.
- The FDA has partnered with experts in healthcare data and analytics to investigate characteristics and clinical outcomes of patients with cancer who are infected with SARS-CoV-2 (the virus that causes COVID-19) in order to improve our understanding of the disease in this population.
FDA has created a special emergency program for possible therapies, the Coronavirus Treatment Acceleration Program (CTAP). It uses every available method to move new treatments to patients as quickly as possible, while at the same time finding out whether they are helpful or harmful. We continue to support clinical trials that are testing new treatments for COVID so that we gain valuable knowledge about their safety and effectiveness.
FDA accelerates the development of prevention and treatment options for COVID-19 by providing new guidance with recommendations for innovators and researchers. These guidance documents aim to make the process for submitting applications to initiate studies for new drugs and biological products more efficient and outline recommendations for ways to design clinical trials to evaluate safety and effectiveness of these medical products for COVID-19.