Clinical Trials and Novel Pathogens: Lessons Learned from SARS
Identifieur interne : 005421 ( Main/Exploration ); précédent : 005420; suivant : 005422Clinical Trials and Novel Pathogens: Lessons Learned from SARS
Auteurs : Matthew P. Muller [Canada] ; Allison Mcgeer [Canada] ; Sharon E. Straus [Canada] ; Laura Hawryluck [Canada] ; Wayne L. Gold [Canada]Source :
- Emerging Infectious Diseases [ 1080-6040 ] ; 2004.
Abstract
During the recent global outbreak of severe acute respiratory syndrome (SARS), thousands of patients received treatments of uncertain efficacy and known toxicity such as ribavirin and corticosteroids. Despite this, no controlled clinical trials assessing the efficacy of these agents were conducted. If a second global SARS outbreak occurred, clinicians would not have controlled data on which to base therapeutic decisions. We discuss the unique methodologic and logistical challenges faced by researchers who attempt to conduct controlled trials of therapeutic agents during an outbreak of a novel or unknown infectious pathogen. We draw upon our own experience in attempting to conduct a randomized controlled trial (trial) of ribavirin therapy for SARS and discuss the lessons learned. Strategies to facilitate future clinical trials during outbreaks of unknown or novel pathogens are also presented.
Url:
DOI: 10.3201/eid1003.030702
PubMed: 15109402
PubMed Central: 3322802
Affiliations:
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Despite this, no controlled clinical trials assessing the efficacy of these agents were conducted. If a second global SARS outbreak occurred, clinicians would not have controlled data on which to base therapeutic decisions. We discuss the unique methodologic and logistical challenges faced by researchers who attempt to conduct controlled trials of therapeutic agents during an outbreak of a novel or unknown infectious pathogen. We draw upon our own experience in attempting to conduct a randomized controlled trial (trial) of ribavirin therapy for SARS and discuss the lessons learned. Strategies to facilitate future clinical trials during outbreaks of unknown or novel pathogens are also presented.</p></div></front><back><div1 type="bibliography"><listBibl><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>Canada</li></country><region><li>Ontario</li></region><settlement><li>Toronto</li></settlement><orgName><li>Université de Toronto</li></orgName></list><tree><country name="Canada"><noRegion><name sortKey="Muller, Matthew P" sort="Muller, Matthew P" uniqKey="Muller M" first="Matthew P." last="Muller">Matthew P. Muller</name></noRegion><name sortKey="Gold, Wayne L" sort="Gold, Wayne L" uniqKey="Gold W" first="Wayne L." last="Gold">Wayne L. Gold</name><name sortKey="Gold, Wayne L" sort="Gold, Wayne L" uniqKey="Gold W" first="Wayne L." last="Gold">Wayne L. Gold</name><name sortKey="Hawryluck, Laura" sort="Hawryluck, Laura" uniqKey="Hawryluck L" first="Laura" last="Hawryluck">Laura Hawryluck</name><name sortKey="Hawryluck, Laura" sort="Hawryluck, Laura" uniqKey="Hawryluck L" first="Laura" last="Hawryluck">Laura Hawryluck</name><name sortKey="Mcgeer, Allison" sort="Mcgeer, Allison" uniqKey="Mcgeer A" first="Allison" last="Mcgeer">Allison Mcgeer</name><name sortKey="Mcgeer, Allison" sort="Mcgeer, Allison" uniqKey="Mcgeer A" first="Allison" last="Mcgeer">Allison Mcgeer</name><name sortKey="Muller, Matthew P" sort="Muller, Matthew P" uniqKey="Muller M" first="Matthew P." last="Muller">Matthew P. Muller</name><name sortKey="Straus, Sharon E" sort="Straus, Sharon E" uniqKey="Straus S" first="Sharon E." last="Straus">Sharon E. Straus</name><name sortKey="Straus, Sharon E" sort="Straus, Sharon E" uniqKey="Straus S" first="Sharon E." last="Straus">Sharon E. Straus</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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