Issues in designing and interpreting clinical trials of treatments for chronic hepatitis C.
Many of the major advances in treating patients for chronic hepatitis C have been made based on the results of randomized, double-blind, controlled clinical trials. However, given the large number of hepatitis C medications in development, physicians need to understand the unique elements and types of clinical trials in order to make accurate comparisons of differing drug efficacy claims. Clinicians also need to be aware of the various factors that can influence the outcomes and interpretations of these trials, irrespective of the intervention under study. For example, similar trials conducted in the United States and Europe may have different outcomes simply because the study populations differ. Thus, both trial design and patient population are important considerations in the design and analysis of clinical trials for patients with chronic hepatitis C.
O'Brien
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Division of GI, Center for Liver Diseases, University of Miami School of Medicine, Miami, FL 33136, USA. cobrien@med.miami.edu
D000998:Antiviral Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D016174:Hepacivirus / Q000254:growth & development*; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D049673:History, 20th Century; D049674:History, 21st Century; D006801:Humans; D016032:Randomized Controlled Trials as Topic / Q000266:history / Q000379:methods* / Q000592:standards; D012107:Research Design; D018401:Sample Size
D000998:Antiviral Agents