Reeve Russell, Pang Lei, Ferguson Bradley, O'Kelly Michael, Berry Seth, Xiao Wei
1 Quintiles, Durham, NC, USA.
2 Merck, Rahway, NJ, USA.
Ther Innov Regul Sci. 2013 Nov;47(6):641-650. doi: 10.1177/2168479013499571.
Time progression models provide a significant advantage in developing clinical trials and can also be used to elicit comparisons among therapeutic agents. The authors performed a meta-analysis to construct a time progression model for rheumatoid arthritis (RA), an area of significant interest for pharmaceutical development, using the ACR20 end point. Compounds studied were chiefly monoclonal antibodies that were used in conjunction with methotrexate. The study shows that an exponential time response model adequately fits the data. From the modeling, a distribution of effects for biological RA therapies can be provided.
时间进展模型在开展临床试验方面具有显著优势,还可用于对治疗药物进行比较。作者进行了一项荟萃分析,以使用美国风湿病学会(ACR)20达标这一终点,构建类风湿关节炎(RA)的时间进展模型,RA是药物研发的一个重要领域。所研究的化合物主要是与甲氨蝶呤联合使用的单克隆抗体。该研究表明指数时间响应模型能很好地拟合数据。通过建模,可以给出生物制剂治疗类风湿关节炎的效应分布情况。