In light of the urgent need for medical intervention during the coronavirus
pandemic, the Department of Health and Human Services (HHS), through the
U.S. Food and Drug Administration (FDA) and the Centers for Disease Control
and Prevention (CDC), has taken action to increase the supply of
respirators available to healthcare providers and provide new guidance on
the conduct of clinical trials.
N-95 Respirators Expiration Dating and Additional Authorizations
On March 3, 2020, both the Centers for Disease Control and Prevention and
the U.S. Food and Drug Administration stated that it is permissible to use
N-95 respirators regulated by National Institute for Occupational Safety
and Health (NIOSH) for healthcare settings.
FDA granted CDC’s emergency use authorization, as requested, because FDA
concluded that NIOSH respirators may be effective in preventing inhalation
of COVID-19 viral particles. This means hospitals and healthcare providers
looking for masks can also consider NIOSHA-approved respirators in the
clinical setting. For manufacturers of NIOSH-regulated N-95 respirators, it
means sales of these respirators for prevention of COVID-19 transition may
be authorized during the national emergency. In all other times, FDA approval would be necessary to introduce an N-95
respirator to market because it is a Class-II device, which requires FDA
Additionally, CDC and FDA have stated that certain models of N-95 masks may
have efficacy past their expiration dates and could be considered for use
after visual inspection.
FDA Guidance on Conduct of Clinical Trials of Medical Products During
On March 18, FDA released "FDA Guidance on Conduct of Clinical Trials of Medical Products During
COVID-19 Pandemic: Guidance for Industry, Investigators, and
Institutional Review Boards” (CT guidance). FDA recognizes the need to reassess compliance with
protocols and human subject protection in light of the current national
crisis. In the CT guidance, FDA emphasized the following considerations for
ongoing clinical trials.
- Safety first. Study decisions should take into account the impact on the
safety of all clinical trial participants. This could also include
continuing use of an investigational product for patients already in the
trial. These decisions are best made in consultation with an Institutional
Review Board (IRB) or Independent Ethics Committee after considering the
risk associated with discontinuing the product and the best way to protect
the safety, welfare, and rights of the study participant.
- Keep all study participants informed about what will happen to the study
and their participation.
- If a clinical trial participant cannot come to the site, consider
alternate methods for contact (phone, virtual visit, alternate location).
Are in-person visits really necessary, given COVID-19?
- For cases where a drug is discontinued, FDA stressed the need to
continue to monitor withdrawal or adverse events from the cessation of an
- COVID-19 screening procedures are likely not necessary to report as a
protocol amendment unless they are part of a new research objective.
- Change first and then report. Protecting the health of the study
participants is paramount. Changes that minimize immediate hazards do not
require immediate reporting to an IRB or filing of an amendment for
protocol change; this can be done after the fact.
- Stick to the protocol as much as possible, but note the deviations
related to COVID-19. Note also the reasons why efficacy endpoints were not
collected and the COVID-19-related reasons for this.
- Sponsors and investigators should work with FDA to inform the agency of
changes taking place to the trial, and work with the IRB to ensure
protection of trial participants.
- In the clinical study report, sponsors should describe to FDA the
following information related to COVID-19:
- The contingency measures implemented
- A list of all participants impacted by COVID-19 study-related
disruptions, by unique subject identification numbers and by study site
(noting how the participation was altered)
- Analysis of how the COVID-19 changes would impact safety and efficacy of
the investigational drug or device
Practically speaking, sponsors, IRBs and investigators should work in
unison regarding any clinical trial changes. Subject safety is the highest
priority and should be emphasized above all else, but balanced in terms of
risks and benefits for the participant.
Great examples of sponsors quickly adapting to social-distancing norms
include mailing drugs to patients, measuring results remotely and figuring
out workarounds for various paperwork issues. It is important to keep in
mind, however, that when adapting isn't feasible and trials must be halted,
force majeure provisions may be triggered.
McGuireWoods has specific experience working with and handling issues in
clinical trials. Please reach out if we may assist further.
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