SPIRIT 2013: new guidance for content of clinical trial protocols

被引:229
作者
Chan, An-Wen [1 ]
Tetzlaff, Jennifer M. [2 ]
Altman, Douglas G. [3 ]
Dickersin, Kay [4 ]
Moher, David [2 ,5 ]
机构
[1] Univ Toronto, Womens Coll Hosp, Dept Med, Womens Coll Res Inst, Toronto, ON M5G 1N8, Canada
[2] Ottawa Hosp Res Inst, Clin Epidemiol Program, Ottawa Methods Ctr, Ottawa, ON, Canada
[3] Univ Oxford, Ctr Stat Med, Oxford, England
[4] Johns Hopkins Bloomberg Sch Publ Hlth, Ctr Clin Trials, Baltimore, MD USA
[5] Univ Ottawa, Dept Epidemiol & Community Med, Ottawa, ON, Canada
关键词
D O I
10.1016/S0140-6736(12)62160-6
中图分类号
R5 [内科学];
学科分类号
100201 [内科学];
摘要
引用
收藏
页码:91 / 92
页数:2
相关论文
共 15 条
[1]
[Anonymous], BMC MED ETHICS
[2]
Bridging the gap: improving clinical development and the regulatory pathways for health products for neglected diseases [J].
Bollyky, Thomas J. ;
Cockburn, Iain M. ;
Berndt, Ernst .
CLINICAL TRIALS, 2010, 7 (06) :719-734
[3]
SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials [J].
Chan, An-Wen ;
Tetzlaff, Jennifer M. ;
Altman, Douglas G. ;
Laupacis, Andreas ;
Gotzsche, Peter C. ;
Krleza-Jeric, Karmela ;
Hrobjartsson, Asbjorn ;
Mann, Howard ;
Dickersin, Kay ;
Berlin, Jesse A. ;
Dore, Caroline J. ;
Parulekar, Wendy R. ;
Summerskill, William S. M. ;
Groves, Trish ;
Schulz, Kenneth F. ;
Sox, Harold C. ;
Rockhold, Frank W. ;
Rennie, Drummond ;
Moher, David .
ANNALS OF INTERNAL MEDICINE, 2013, 158 (03) :200-+
[4]
SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials [J].
Chan, An-Wen ;
Tetzlaff, Jennifer M. ;
Gotzsche, Peter C. ;
Altman, Douglas G. ;
Mann, Howard ;
Berlin, Jesse A. ;
Dickersin, Kay ;
Hrobjartsson, Asbjorn ;
Schulz, Kenneth F. ;
Parulekar, Wendy R. ;
Krleza-Jeric, Karmela ;
Laupacis, Andreas ;
Moher, David .
BMJ-BRITISH MEDICAL JOURNAL, 2013, 346
[5]
Empirical evidence for selective reporting of outcomes in randomized trials -: Comparison of Protocols to published articles [J].
Chan, AW ;
Hróbjartsson, A ;
Haahr, MT ;
Gotzsche, PC ;
Altman, DG .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2004, 291 (20) :2457-2465
[6]
Comparison of protocols and registry entries to published reports for randomised controlled trials [J].
Dwan, Kerry ;
Altman, Douglas G. ;
Cresswell, Lynne ;
Blundell, Michaela ;
Gamble, Carrol L. ;
Williamson, Paula R. .
COCHRANE DATABASE OF SYSTEMATIC REVIEWS, 2011, (01)
[7]
Measuring the Incidence, Causes, and Repercussions of Protocol Amendments [J].
Getz, Kenneth A. ;
Zuckerman, Rachael ;
Cropp, Anne B. ;
Hindle, Anna L. ;
Krauss, Randy ;
Kaitin, Kenneth I. .
DRUG INFORMATION JOURNAL, 2011, 45 (03) :265-275
[8]
Access to data in industry-sponsored trials [J].
Lundh, Andreas ;
Krogsboll, Lasse T. ;
Gotzsche, Peter C. .
LANCET, 2011, 378 (9808) :1995-1996
[9]
National Research Council Panel on Handling Missing Data in Clinical Trials, 2010, The Prevention and Treatment of Missing Data in Clinical Trials
[10]
Russ Hagen, 2009, Ger Med Sci, V7, pDoc07, DOI 10.3205/000066