Evaluating the evidence from clinical trials in chronic hepatitis C.
A number of studies are being published on investigational agents for the treatment of patients with chronic hepatitis C. Before incorporating new medications into therapy or electing to postpone therapy until an investigational agent receives regulatory approval, it is important to evaluate the following specific features of the published evidence: quality of the evidence, precision of the treatment effect, magnitude of the treatment effect, magnitude of the hazards, and other factors such as risk-benefit analysis and cost, including cost-effectiveness. Previous studies of treatment of patients with the disease allow us to establish some benchmarks and provide structure to evaluate the evidence of the efficacy and safety of these newer drugs.
Brown
R S
RS
Center for Liver Disease & Transplantation, Columbia University College of Physicians & Surgeons, New York, NY 10032, USA. rb464@columbia.edu
D000998:Antiviral Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D016174:Hepacivirus / Q000254:growth & development*; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D007372:Interferons / Q000627:therapeutic use; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012254:Ribavirin / Q000627:therapeutic use; D016896:Treatment Outcome
D000998:Antiviral Agents; D012254:Ribavirin; D007372:Interferons