The FDA is expediting the development of treatments for COVID-19 in a new program called the Coronavirus Treatment Acceleration Program (CTAP) and offering new guidance on conducting clinical trials of all medical products during the pandemic.
Coronavirus Treatment Acceleration Program
On March 31, 2020 the FDA began cutting red tape, redeploying staff and working 24 hours a day to review requests from companies, scientists and doctors who are working toward therapies. Staff from the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research are providing regulatory advice, guidance and technical assistance “as quickly as possible.”
For example, the agency has reviewed study protocols within 24 hours in many cases and has reviewed single-patient expanded access requests generally within three hours.
There are a variety of therapeutic areas being evaluated, according to the FDA announcement, including “antiviral drugs like remdesivir that might treat the specific virus, as well as host targets, such as interleukin-6 (IL-6) receptor inhibitors that may be helpful in reducing lung inflammation and improving lung function in COVID-19 patients.”
“There’s also interest in examining whether therapies such as convalescent plasma and hyperimmune globulin, antibody-rich blood products that are taken from blood donated by people who have recovered from the virus, could shorten the length or lessen the severity of the illness. Work is also ongoing to evaluate whether existing therapies such as chloroquine and hydroxychloroquine (with or without other medications) help treat patients with COVID-19.”
Clinical Trials During Pandemic
In addition to expediting treatment development, the agency noted the pandemic may impact the conduct of clinical trials of all medical products.
To that end, the agency issued an updated guidance on March 27, 2020, entitled: “Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic,” with an appendix adding questions and answers.
The agency said it knows clinical trials may be impacted from quarantines, site closures, travel limitations, interruptions to the supply chain for the investigational product, or other considerations if site personnel or trial subjects become infected with COVID-19.
“These challenges may lead to difficulties in meeting protocol-specified procedures, including administering or using the investigational product or adhering to protocol-mandated visits and laboratory/diagnostic testing.”
If your trial is impacted by the pandemic, you should describe in appropriate sections of the clinical study report (or in a separate study-specific document):
- Contingency measures implemented to manage study conduct during disruption of the study as a result of COVID-19 control measures.
- A listing of all participants affected by the COVID-19 related study disruption by unique subject number identifier and by investigational site, and a description of how the individual’s participation was altered.
- Analyses and corresponding discussions that address the impact of implemented contingency measures (e.g., trial participant discontinuation from investigational product and/or study, alternative procedures used to collect critical safety and/or efficacy data) on the safety and efficacy results reported for the study.