Clinical design of a non-inferiority trial and its quantitative evaluation in the patient with mild-to-moderate active ulcerative colitis
10.3969/j.issn.1001-6821.2010.03.012
- VernacularTitle:慢性活动期溃疡性结肠炎非劣效临床试验设计及其定量评价
- Author:
Shi-Mei WEN
1
;
Lu-Jin LI
;
Jan-Chao CHEN
;
Hong-Xia LIU
;
Qing-Shan ZHENG
Author Information
1. 上海中医药大学
- Keywords:
ulcerative colitis;
non-inferiority design;
non-inferiority margin
- From:
The Chinese Journal of Clinical Pharmacology
2010;26(3):209-212
- CountryChina
- Language:Chinese
-
Abstract:
Objective To introduce the design of a non-inferiority clinical trial for evaluating the mild-to-moderate active ulcerative coli-tis. Methods Based on international literature and the European guide-line on the development of new medicinal products for the treatment of ul-cerative colitis, a clinical trial was designed in involving with the positive control, non-inferiority margin, primary endpoint and the dose-finding within accepted efficacy and safety for a treatment of mild-to-moderate active ulcerative colitis. A real example of ulcerative colitis was intro-duced and its primary data were simulated for quantitative analysis. Re-sult For the non-inferiority clinical trial on mild-to-moderate active ulcerative colitis, the standard positive control should be aminosalicylic acid (5-ASA) with the dose of 3 g/day, the non-inferior margin is approximately 15%, and the CAI scale is recommended as primary end-point. Conclusion This study can provide some important information for similar clinical research.
