Developing Treatment Guidelines During a Pandemic Health Crisis: Lessons Learned From COVID-19 (Special Article) has been published in The Annals of Internal Medicine, the result of a collective effort by Maternal-Fetal Medicine specialist Brenna Hughes, MD, MSc, (pictured) and colleagues on the National Institutes of Health (NIH) COVID-19 Treatments Guidelines Panel. Susanna Naggie, MD, MHS, Vice Dean for Clinical Research and Associate Professor of Medicine at Duke, was also a Panel member/contributor.
The article includes information on the following:
- Navigating U.S. Food and Drug Administration Emergency Use Authorizations
- Children and Pregnant Individuals
- Communicating with Stakeholders: Clinicians and the Public
As the COVID-19 pandemic unfolded, healthcare providers needed credible, evidence-based guidelines. In the setting of rapidly expanding clinical information about a new disease, coordinated synthesis and dissemination of credible information was of critical importance. As a convening body, NIH had the scientific credibility and the resources to recruit experts in multiple clinical disciplines to establish a Panel to meet this need. In March 2020, the White House Coronavirus Task Force, through the Secretary of Health and Human Services, asked the NIH to develop evidence-based guidelines for the treatment of patients with COVID-19. Although the NIH rarely sponsors guidelines, NIH sponsorship of a COVID-19 guideline was warranted in this instance given the urgency of the public health emergency and the ability of NIH to immediately launch an adequately resourced response. the publication states.
- The Panel comprises 57 individuals representing 6 governmental agencies, 11 professional societies and 33 medical centers, plus 2 community members, who have worked together to create and frequently update the guidelines on the basis of evidence from the most recent clinical studies available.
- The initial version of the guidelines was completed within 2 weeks and posted online on April 21, 2020.
- Initially, sparse evidence was available to guide COVID-19 treatment recommendations. However, treatment data rapidly accrued based on results from clinical studies that used various study designs and evaluated different therapeutic agents and approaches.
- Data have continued to evolve at a rapid pace, leading to 24 revisions and updates of the guidelines in the first year.