O'Brien C
Division of GI, Center for Liver Diseases, University of Miami School of Medicine, Miami, FL 33136, USA.
J Viral Hepat. 2006 May;13 Suppl 1:6-14. doi: 10.1111/j.1365-2893.2006.00757.x.
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.
慢性丙型肝炎患者治疗方面的许多重大进展都是基于随机、双盲、对照临床试验的结果取得的。然而，鉴于有大量丙型肝炎药物正在研发中，医生需要了解临床试验的独特要素和类型，以便对不同药物的疗效声明进行准确比较。临床医生还需要意识到可能影响这些试验结果和解读的各种因素，无论所研究的干预措施是什么。例如，在美国和欧洲进行的类似试验可能会有不同结果，仅仅是因为研究人群不同。因此，试验设计和患者群体都是慢性丙型肝炎患者临床试验设计和分析中的重要考虑因素。
