Planning and core analyses for periodic aggregate safety data reviews

被引：12
作者：
Xia, H. Amy [2 ]
Crowe, Brenda J. [1 ]
Schriver, Robert C. [3 ]
Oster, Manfred [4 ]
Hall, David B. [5 ]
机构：
[1] Eli Lilly & Co, Lilly Corp Ctr, Indianapolis, IN 46285 USA
[2] Amgen Inc, Thousand Oaks, CA 91320 USA
[3] GlaxoSmithKline Inc, King Of Prussia, PA USA
[4] Sanofi Aventis, Bridgewater, MA USA
[5] Boehringer Ingelheim Pharmaceut Inc, Ridgefield, CT USA
来源：
CLINICAL TRIALS | 2011年 / 8卷 / 02期
关键词：
CLINICAL-TRIALS; DRUG;
D O I：
10.1177/1740774510395635
中图分类号：
R-3 [医学研究方法]; R3 [基础医学];
学科分类号：
1001 ;
摘要：
Background In 2009, the Safety Planning, Evaluation and Reporting Team gave detailed recommendations for a well-planned and systematic approach for safety data collection and analysis. Important aspects of this approach included regular reviews of aggregate data by a multidisciplinary team focusing on safety. Purpose This article provides information to facilitate the planning and implementation of aggregate data reviews. Methods Our recommendations are based on experience of the authors and review of relevant literature. Results We present information regarding the planning of aggregate data reviews as well as examples of data displays that are useful for many different compounds. A subset of these data displays could form a set of 'core' analyses to be generated for aggregate data reviews. Clinical Trials 2011; 8: 175-182. http://ctj.sagepub.com
引用
收藏
页码：175 / 182
页数：8
相关论文
共 13 条
[1]   Graphical approaches to the analysis of safety data from clinical trials [J].
Amit, Ohad ;
Heiberger, Richard M. ;
Lane, Peter W. .
PHARMACEUTICAL STATISTICS, 2008, 7 (01) :20-35
[2]  
[Anonymous], 2011, The statistical analysis of failure time data
[3]   Accounting for multiplicities in assessing drug safety: A three-level hierarchical mixture model [J].
Berry, SM ;
Berry, DA .
BIOMETRICS, 2004, 60 (02) :418-426
[4]   Reporting cumulative proportion of subjects with an adverse event based on data from multiple studies [J].
Chuang-Stein, Christy ;
Beltangady, Mohan .
PHARMACEUTICAL STATISTICS, 2011, 10 (01) :3-7
[5]  
CIOMS Working Group VI, 2005, Report of CIOMS working group VI
[6]   Recommendations for safety planning, data collection, evaluation and reporting during drug, biologic and vaccine development: a report of the safety planning, evaluation, and reporting team [J].
Crowe, Brenda J. ;
Xia, H. Amy ;
Berlin, Jesse A. ;
Watson, Douglas J. ;
Shi, Hongliang ;
Lin, Stephen L. ;
Kuebler, Juergen ;
Schriver, Robert C. ;
Santanello, Nancy C. ;
Rochester, George ;
Porter, Jane B. ;
Oster, Manfred ;
Mehrotra, Devan V. ;
Li, Zhengqing ;
King, Eileen C. ;
Harpur, Ernest S. ;
Hall, David B. .
CLINICAL TRIALS, 2009, 6 (05) :430-440
[7]  
Guo T., 2008, A tool to help you decide (detect potentially serious liver injury)
[8]   Forest plots: trying to see the wood and the trees [J].
Lewis, S ;
Clarke, M .
BMJ-BRITISH MEDICAL JOURNAL, 2001, 322 (7300) :1479-1480
[9]   DATA MINING AND STATISTICALLY GUIDED CLINICAL REVIEW OF ADVERSE EVENT DATA IN CLINICAL TRIALS [J].
Southworth, H. ;
O'Connell, M. .
JOURNAL OF BIOPHARMACEUTICAL STATISTICS, 2009, 19 (05) :803-817
[10]  
U.S. Food and Drug Administration, 2010, GUID IND INV SAF REP
12