Monitoring and Assessment of Medical Countermeasures as Part of a Public Health Emergency Response

Monitoring and Assessment of Medical Countermeasures as Part of a Public Health Emergency Response

In response to the 2009 H1N1 influenza pandemic, researchers were unable to assess the clinical effectiveness of intravenous peramivir, an unapproved drug made available under an Emergency Use Authorization.2 Although an Emergency Use Authorization provided access to peramivir, use of a product unde...

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Bibliographic Details
Published in:American journal of public health (1971) Vol. 108; no. S3; pp. S224 - S226
Main Authors: Measer, Gregory T, Maher, Carmen T, Hu-Primmer, Jean
Format: Journal Article
Language:English
Published: United States American Public Health Association 01-09-2018
Subjects:
21st century
AJPH Surveillance
Clinical decision making
Clinical trials
Data collection
Decision making
Ebola virus
Emergency medical services
Emergency preparedness
Emergency response
Ethics
Food
Health Policy
Health surveillance
Infectious diseases
Influenza
Infrastructure
Innovations
Medical innovations
Pandemics
Product development
Public health
R&D
Research & development
Safety
Swine flu
United States > US
West Africa
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Description
Summary:In response to the 2009 H1N1 influenza pandemic, researchers were unable to assess the clinical effectiveness of intravenous peramivir, an unapproved drug made available under an Emergency Use Authorization.2 Although an Emergency Use Authorization provided access to peramivir, use of a product under this authorization yields little data beyond standard adverse event reporting. Throughout the 2014-2015 Ebola virus disease outbreak in West Africa, the FDA maintained that randomized controlled trials that incorporate advances in trial design could yield needed safety and effectiveness data in an ethical way.3 But randomized controlled trials can be challenging to plan and conduct during an emergency. With the recent passage of the 21st Century Cures Act, the FDA will continue to support innovations in medical product development and facilitate the use of realworld evidence in regulatory decision-making.5 Though traditional randomized controlled trials remain the gold standard for medical product assessment, there is a need for new and novel ways to collect and analyze data for scientifically sound evaluation of MCMs.6 Collecting and using data in a more efficient way requires more than just infrastructure and technology.
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All authors contributed equally to this article.
CONTRIBUTORS
Note. This article reflects the views of the authors and should not be construed to represent the US Food and Drug Administration’s views or policies.
ISSN:0090-0036
1541-0048
DOI:10.2105/AJPH.2018.304526