Reagan-Udall Foundation launches COVID-19 treatment hub
The nonprofit Reagan-Udall Foundation for the FDA on Wednesday launched an expansion to its expanded access navigator to help patients and physicians identify potential treatments for coronavirus disease (COVID-19) via clinical trials and expanded access programs.The foundation says the COVID-19 treatment hub was developed at the request of the US Food and Drug Administration and includes a directory of COVID-19 therapies in development and a listing of clinical trials and expanded access programs pulled from ClinicalTrials.gov. (RELATED: FDA’s Nonprofit Arm Plots Out New Compassionate Use Navigator, Regulatory Focus 7 April 2016; FDA Launches Expanded Access Pilot ‘Project Facilitate’, Regulatory Focus 3 June 2019).
The treatment hub features a directory listing more than 50 companies and institutions with links to their expanded access policies and relevant information about products being developed to treat COVID-19.
More than 500 studies and expanded access programs from around the world are currently featured within the hub. However, not all the studies listed are interventional or involve investigational products, and some are unrelated to treating COVID-19, such as one study looking at the impact of phone consultations for endoscopy-related outpatient appointments during the COVID-19 outbreak.
The hub also provides an overview of some of the major treatments under investigations to treat COVID-19, such as the anti-malaria drugs chloroquine and hydroxychloroquine and convalescent plasma, and links to other coronavirus resources from FDA. (RELATED: Convalescent Plasma: FDA Facilitating Emergency Access, Regulatory Focus 24 March 2020; FDA EUA Allows States to Receive Unapproved COVID-19 Treatments, Regulatory Focus 30 March 2020).
Holly Fernandez Lynch, assistant professor of medical ethics at the University of Pennsylvania, told Focus she thinks having a centralized treatment hub for stakeholders is helpful, but said she would prefer to see more messaging about the investigational nature of the interventions it features.
“I think the site is a missed opportunity to help people understand the current state of uncertainty and the need for rigorous investigation. Even something as small as continually calling these products ‘treatments’ can be misleading,” Fernandez Lynch said.
Fernandez Lynch noted that the issue is not that the treatments are not FDA-approved, but that we still don’t know what treatments will work for patients.
“Ideally the message would not be that we need clinical trials for the purpose of gaining regulatory approvals, but rather that we need clinical trials to tell us what’s safe and effective, with regulatory approvals to follow,” Fernandez Lynch said.
Reagan-Udall Foundation