Time-of-Essence Challenge Issued to COVID-19 Developers
The 16th Director of the US National Institutes of Health (NIH) issued a ‘time-of-essence’ challenge to the vaccine research industry.
On November 10, 2020, Francis S. Collins, M.D., Ph.D. issued a statement saying ‘ the NIH is taking an all-hands-on-deck approach to speeding life-saving research for vaccines, treatments, and diagnostic tests to end the COVID-19 pandemic.’
And ‘through the establishment of major public-private initiatives such as the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) and the Rapid Acceleration of Diagostics (RADx) initiatives, the NIH and its partners, have launched dozens of COVID-19 vaccine and treatment clinical trials and funded dozens of new and innovative testing technologies at an unprecedented rate.’
‘To maintain this record pace, it will be crucial for clinical researchers involved in COVID-19 and SARS-CoV-2 clinical trials to share their results as swiftly as possible.’
‘Toward this end, I strongly encourage the clinical research community to register their clinical trials and submit summary results information for COVID-19 and SARS-CoV-2 trials as quickly as possible and ahead of regulatory and policy deadline requirements to ClinicalTrials.gov, the publicly accessible database operated by NIH’s National Library of Medicine.’
‘To ensure such information is accessible as quickly as possible, NIH is prioritizing the processing of COVID-19 submissions to ClinicalTrials.gov to make the information rapidly available in a matter of days, not weeks.”
“We are also providing one-on-one support to researchers during the process of submitting results information to ClinicalTrials.gov to address questions and optimize reporting.’
Furthermore, the ‘NIH has taken several additional actions to speed access and discoverability for researchers, clinicians, and the public of critical information from COVID-19 and SARS-CoV-2 research, including, but not limited to, the following:
- Supporting the infrastructure for timely dissemination of COVID-19 clinical trial data.
- Making it easier to find information about COVID-19-related studies on ClinicalTrials.gov, including information about studies listed on the World Health Organization’s International Clinical Trial Registry Platform. These efforts have made information about more than 6,400 COVID-19 related clinical studies readily available to those who need it.
- Launching a preprint pilot, which has made more than 1,000 preprints with early reporting on NIH-funded research related to COVID-19 discoverable through PubMed. More than 80 percent of these preprints have yet to be published, highlighting the importance of this pilot effort in accelerating early access to research results ahead of peer-reviewed publications.
‘The scientific community bears collective responsibility for expediting the dissemination of knowledge from NIH-funded research. Doing so will bring COVID-19 treatments and vaccines to the American public and the world as quickly as possible, concluded Dr. Collins remarks.
Francis S. Collins, M.D., Ph.D.. has been the director of the U.S. NIH since 2017. Dr. Collins is a physician-geneticist noted for his landmark discoveries of disease genes and his leadership of the international Human Genome Project.
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