TY - JOUR
T1 - A semi-parametric analysis for identifying Scleroderma patients responsive to an anti-fibrotic agent
AU - Li, Jialiang
AU - Wong, Weng Kee
N1 - Funding Information:
The research of Li was supported in part by National University of Singapore Research Grants, and the research of Wong was supported in part by a Senior Investigator Grant from The Scleroderma Foundation. The principal investigator of the Type I Bovine Collagen Trial was Dr. Postlethwaite from the University of Tennessee at Memphis and we thank him for permission to use the data.
PY - 2009/3
Y1 - 2009/3
N2 - In a recently concluded multi-center two-armed clinical trial for Scleroderma patients, results from a variety of analyses based on parametric models showed that late phase patients benefited from the bovine collagen treatment at 15 months and the placebo group did not. However, the cutoff time for defining early or late phase patients was somewhat arbitrary and sample size for late phase patients was small in the two groups. We apply a combination of semi-parametric and parametric approaches to further ascertain treatment efficacy and address modeling issues related to the choice of the cutoff and the scientific hypothesis of interest. We compare results with those obtained from parametric models and demonstrate how semi-parametric methods can help to better identify Scleroderma patients responsive to an anti-fibrotic agent.
AB - In a recently concluded multi-center two-armed clinical trial for Scleroderma patients, results from a variety of analyses based on parametric models showed that late phase patients benefited from the bovine collagen treatment at 15 months and the placebo group did not. However, the cutoff time for defining early or late phase patients was somewhat arbitrary and sample size for late phase patients was small in the two groups. We apply a combination of semi-parametric and parametric approaches to further ascertain treatment efficacy and address modeling issues related to the choice of the cutoff and the scientific hypothesis of interest. We compare results with those obtained from parametric models and demonstrate how semi-parametric methods can help to better identify Scleroderma patients responsive to an anti-fibrotic agent.
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U2 - 10.1016/j.cct.2008.10.003
DO - 10.1016/j.cct.2008.10.003
M3 - Article
C2 - 19013258
AN - SCOPUS:60249088688
SN - 1551-7144
VL - 30
SP - 105
EP - 113
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
IS - 2
ER -