Operating characteristics of a Simon two-stage phase II clinical trial design incorporating continuous toxicity monitoring [0.03%]
基于连续毒性监测的Simon两阶段二期临床试验设计的运行特性分析
H E Ray,S N Rai
H E Ray
Phase II clinical trials are usually designed to measure efficacy, but safety is also an important end point. Previous authors recommended a method to monitor toxic events after each patient is enrolled, which is also known as continuously ...
Exact sample-size determination in testing non-inferiority under a simple crossover trial [0.03%]
简略交叉设计下检验非劣效性的样本量精确确定方法
Kung-Jong Lui,Kuang-Chao Chang
Kung-Jong Lui
For testing the non-inferiority (or equivalence) of an experimental treatment to a standard treatment, the odds ratio (OR) of patient response rates has been recommended to measure the relative treatment efficacy. On the basis of an exact t...
Comparative Study
Pharmaceutical statistics. 2012 Mar-Apr;11(2):129-34. DOI:10.1002/pst.506 2012
Mario Hasler
Mario Hasler
This paper addresses multiple comparisons in the presence of both a negative and a positive control. The methodology of the three-arm trial is extended to the case of many experimental treatment arms or different doses of a compound. In con...
Statistical approaches for conducting network meta-analysis in drug development [0.03%]
药物研发中开展网络 Meta 分析的统计方法学进展
Byron Jones,James Roger,Peter W Lane et al.
Byron Jones et al.
We introduce health technology assessment and evidence synthesis briefly, and then concentrate on the statistical approaches used for conducting network meta-analysis (NMA) in the development and approval of new health technologies. NMA is ...
Chia-Min Chen,Yunchan Chi
Chia-Min Chen
When phase I clinical trials were found to be unable to precisely estimate the frequency of toxicity, Brayan and Day proposed incorporating toxicity considerations into two-stage designs in phase II clinical trials. Conaway and Petroni furt...
Martin Jenkins,Aiden Flynn,Trevor Smart et al.
Martin Jenkins et al.
Biomarkers play an increasingly important role in many aspects of pharmaceutical discovery and development, including personalized medicine and the assessment of safety data, with heavy reliance being placed on their delivery. Statisticians...
Carl-Fredrik Burman,Stig Johan Wiklund
Carl-Fredrik Burman
Modelling and simulation (M&S) is increasingly being applied in (clinical) drug development. It provides an opportune area for the community of pharmaceutical statisticians to pursue. In this article, we highlight useful principles behind t...
Scott D Patterson,Byron Jones
Scott D Patterson
The two one-sided test procedure (TOST) has been used for average bioequivalence testing since 1992 and is required when marketing new formulations of an approved drug. TOST is known to require comparatively large numbers of subjects to dem...
Subgroup analyses of clinical effectiveness to support health technology assessments [0.03%]
临床有效性亚组分析支持卫生技术评估
Marie-Ange Paget,Christy Chuang-Stein,Christine Fletcher et al.
Marie-Ange Paget et al.
Subgroup analysis is an integral part of access and reimbursement dossiers, in particular health technology assessment (HTA), and their HTA recommendations are often limited to subpopulations. HTA recommendations for subpopulations are not ...
An assessment of the statistical methods used to analyse toxicology studies [0.03%]
评估毒理学研究分析所使用统计方法的优劣
Philip Jarvis,Jim Saul,Mike Aylott et al.
Philip Jarvis et al.
The Statisticians in the Pharmaceutical Industry Toxicology Special Interest Group has collated and compared statistical analysis methods for a number of toxicology study types including general toxicology, genetic toxicology, safety pharma...