Streamlining Adverse Events Reporting in Oncology: An American Society of Clinical Oncology Research Statement

被引:18
作者
Levit, Laura A. [1 ]
Perez, Raymond P. [2 ]
Smith, David C. [3 ]
Schilsky, Richard L. [1 ]
Hayes, Daniel F. [3 ]
Vose, Julie M. [4 ]
机构
[1] Amer Soc Clin Oncol, 2318 Mill Rd, Alexandria, VA 22314 USA
[2] Bristol Myers Squibb, Lawrence Township, NJ USA
[3] Univ Michigan, Ann Arbor, MI 48109 USA
[4] Univ Nebraska Med Ctr, Omaha, NE USA
关键词
DRUG SAFETY REPORTS; TRIALS; CANCER; SPONSORS; QUALITY; RULE; IND; FDA;
D O I
10.1200/JCO.2017.75.8193
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
[No abstract available]
引用
收藏
页码:617 / +
页数:9
相关论文
共 30 条
[1]  
[Anonymous], CTTI IND SAF ADV PRO
[2]   Optimizing Expedited Safety Reporting for Drugs and Biologics Subject to an Investigational New Drug Application [J].
Archdeacon, Patrick ;
Grandinetti, Cheryl ;
Vega, Jose M. ;
Balderson, David ;
Kramer, Judith M. .
THERAPEUTIC INNOVATION & REGULATORY SCIENCE, 2014, 48 (02) :200-207
[3]   Reporting of Serious Adverse Events During Cancer Clinical Trials to the Institutional Review Board: An Evaluation by the Research on Adverse Drug Events And Reports (RADAR) Project [J].
Belknap, S. M. ;
Georgopoulos, C. H. ;
Lagman, J. ;
Weitzman, S. A. ;
Qualkenbush, L. ;
Yarnold, P. R. ;
Edwards, B. J. ;
McKoy, J. M. ;
Trifilio, S. M. ;
West, D. P. .
JOURNAL OF CLINICAL PHARMACOLOGY, 2013, 53 (12) :1334-1340
[4]   Quality of Methods for Assessing and Reporting Serious Adverse Events in Clinical Trials of Cancer Drugs [J].
Belknap, S. M. ;
Georgopoulos, C. H. ;
West, D. P. ;
Yarnold, P. R. ;
Kelly, W. N. .
CLINICAL PHARMACOLOGY & THERAPEUTICS, 2010, 88 (02) :231-236
[5]   The Feasibility, Perceived Satisfaction, and Value of Using Synchronous Webinars to Educate Clinical Research Professionals on Reporting Adverse Events in Clinical Trials: A Report From the Children's Oncology Group [J].
Borgerson, Dawn ;
Dino, Jennifer .
JOURNAL OF PEDIATRIC ONCOLOGY NURSING, 2012, 29 (06) :316-322
[6]  
Clinical Trials Transformation Initiative, PROJ SAF REP
[7]  
Clinical Trials Transformation Initiative, CAS STUD EXP IND SAF
[8]   Quality of serious adverse events reporting to academic sponsors of clinical trials: far from optimal [J].
Crepin, Sabrina ;
Villeneuve, Claire ;
Merle, Louis .
PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, 2016, 25 (06) :719-724
[9]  
Delgra CJ:, 2017, WORLD DRUG SAF C AM
[10]  
Delgra CJ, 2016, PHARM FIN RUL SUMM I