title: Clinical trials and novel pathogens: lessons learned from SARS.
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.
authors.affiliation: Mount Sinai Hospital, Toronto, Ontario, Canada.
authors.forename: Matthew P
authors.initials: MP
authors.lastname: Muller
authors.forename: Allison
authors.initials: A
authors.lastname: McGeer
authors.forename: Sharon E
authors.initials: SE
authors.lastname: Straus
authors.forename: Laura
authors.initials: L
authors.lastname: Hawryluck
authors.forename: Wayne L
authors.initials: WL
authors.lastname: Gold
mesh_terms: D000998:Antiviral Agents / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D021821:Communicable Diseases, Emerging / Q000188:drug therapy*; D004196:Disease Outbreaks; D006801:Humans; D012254:Ribavirin / Q000627:therapeutic use*; D045169:Severe Acute Respiratory Syndrome / Q000188:drug therapy* / Q000453:epidemiology
chemical_list: D000998:Antiviral Agents; D012254:Ribavirin