Clinical trials and novel pathogens: lessons learned from SARS

doi:10.3201/eid1003.030702

. 2004 Mar;10(3):389-94.

doi: 10.3201/eid1003.030702.

Clinical trials and novel pathogens: lessons learned from SARS

Matthew P Muller¹, Allison McGeer, Sharon E Straus, Laura Hawryluck, Wayne L Gold

Affiliations

PMID: 15109402
PMCID: PMC3322802
DOI: 10.3201/eid1003.030702

Clinical trials and novel pathogens: lessons learned from SARS

Matthew P Muller et al. Emerg Infect Dis. 2004 Mar.

. 2004 Mar;10(3):389-94.

doi: 10.3201/eid1003.030702.

Authors

Matthew P Muller¹, Allison McGeer, Sharon E Straus, Laura Hawryluck, Wayne L Gold

Affiliation

¹ Mount Sinai Hospital, Toronto, Ontario, Canada.

PMID: 15109402
PMCID: PMC3322802
DOI: 10.3201/eid1003.030702

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.

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Figures

**Figure**
Epidemic curve of the first Toronto SARS outbreak. Data provided courtesy of the Ministry of Health and Long Term Care, Ontario, Canada.

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References

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[1] Peiris JSM, Lai ST, Poon LLM, Guan Y, Yam LYC, Lim W, et al. Coronavirus as a possible cause of severe acute respiratory syndrome. Lancet. 2003;361:1319–25. 10.1016/S0140-6736(03)13077-2 - DOI - PMC - PubMed

[2] Peiris JSM, Lai ST, Poon LLM, Guan Y, Yam LYC, Lim W, et al. Coronavirus as a possible cause of severe acute respiratory syndrome. Lancet. 2003;361:1319–25. 10.1016/S0140-6736(03)13077-2 - DOI - PMC - PubMed

[3] Drosten C, Gunther S, Preiser W, van der Werf S, Brodt H-R, Becker S, et al. Identification of a novel coronavirus in patients with severe acute respiratory syndrome. N Engl J Med. 2003;348:1967–78. 10.1056/NEJMoa030747 - DOI - PubMed

[4] Drosten C, Gunther S, Preiser W, van der Werf S, Brodt H-R, Becker S, et al. Identification of a novel coronavirus in patients with severe acute respiratory syndrome. N Engl J Med. 2003;348:1967–78. 10.1056/NEJMoa030747 - DOI - PubMed

[5] Ksiazek TG, Erdman D, Goldsmith C, Zaki SR, Peret T, Emery S, et al. A novel coronavirus associated with severe acute respiratory syndrome. N Engl J Med. 2003;348:1953–66. 10.1056/NEJMoa030781 - DOI - PubMed

[6] Ksiazek TG, Erdman D, Goldsmith C, Zaki SR, Peret T, Emery S, et al. A novel coronavirus associated with severe acute respiratory syndrome. N Engl J Med. 2003;348:1953–66. 10.1056/NEJMoa030781 - DOI - PubMed

[7] Centers for Disease Control and Prevention. Update: severe acute respiratory disease—worldwide and United States, 2003. Morb Mortal Wkly Rep MMWR. 2003;52:664–5. - PubMed

[8] Centers for Disease Control and Prevention. Update: severe acute respiratory disease—worldwide and United States, 2003. Morb Mortal Wkly Rep MMWR. 2003;52:664–5. - PubMed

[9] Crotty S, Maag D, Arnold JL, Zhong W, Lau JYN, Hong ZH, et al. The broad-spectrum antiviral ribonucleoside ribavirin is an RNA virus mutagen. Nat Med. 2000;6:1375–8. 10.1038/82191 - DOI - PubMed

[10] Crotty S, Maag D, Arnold JL, Zhong W, Lau JYN, Hong ZH, et al. The broad-spectrum antiviral ribonucleoside ribavirin is an RNA virus mutagen. Nat Med. 2000;6:1375–8. 10.1038/82191 - DOI - PubMed

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Clinical trials and novel pathogens: lessons learned from SARS

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Clinical trials and novel pathogens: lessons learned from SARS

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