Safety Scientific Working Group

 

American Statistical Association
Biopharmaceutical Section
Safety References Library
Initial Test Version – more to be added in time

 

Note and Disclaimer: The safety references contained here are for general information purposes only. They include references from various sources such as journal articles, books and book chapters, workshop presentations, and guidance documents related to drug safety data. The information is provided by ASA Biopharmaceutical Section as is, along with hyperlinks to the source references which are available for users with legal access to the given reference or if it is available freely online. While the ASA Biopharmaceutical Section continually updates and corrects the information, it does not make a warranty of any kind, express or implied, about the completeness or availability with respect to the reference information. The ASA Biopharmaceutical Section also has no control over the nature, content and availability of hyperlinks provided with regard to when they become nonfunctional. The inclusion of any reference does not imply a recommendation or endorsement of the views expressed within them. References are collected by searching with PubMed, CIS, and online search engines using but not limited to terms such as “safety monitoring, interim safety check, interim analysis with safety, ongoing safety assessment … .”  Users of the library are also encouraged to submit references suggestions for possible addition to the library.

 

Send comments to the Safety References Library Team

  • General Considerations and Challenges in the Analysis of Safety Data
  • Standard Analysis of Adverse Events
  • Analysis of Safety Data from Spontaneous Reporting Systems
  • Safety Monitoring

 

References for General Considerations and Challenges - Journal Articles, No Abstracts  

  1. B.J. Crowe, H. A. Xia, J. A Berlin, and et al, 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, Clinical Trials, 6 (2009), 430 ‒ 440.
  2. S. Singh and Y. Loke, Drug safety assessment in clinical trials: methodological challenges and opportunities, Trials, 13 (2012), 1 ‒ 8.
  3. H. A. Xia, B. J. Crowe, R. C. Schriver, M. Oster, and D. B Hall, Planning and core analyses for periodic aggregate safety data reviews, Clinical Trials, 8 (2011), 175 ‒ 182.
  4. H. A. Xia and Q. Jiang, Statistical evaluation of drug safety data, Therapeutic Innovation and Regulatory Science, 48 (2014), 109 ‒ 120.

 

References for Standard Analysis of Adverse Events - Journal Articles, No Abstracts

  1. D. Cao and X. He, Statistical analysis of adverse events in randomized clinical trials using SAS, PharmaSUG 2011, Paper SP07.
  2. I. S. F. Chan and W. B. Wang, On analysis of the difference of two exposure-adjusted Poisson rates with stratification: From asymptotic to exact approaches, Statistics Biosciences 1(2009), 65 ‒ 79.
  3. G. F. Liu, On analysis of low incidence adverse events in clinical trials, Topics in Applied Statistics: 2012 Symposium of the International Chinese Statistical Association (M. Hu, et al, ed.), Springer Proceedings in Mathematics and Statistics, 55, New York, 2012, pp. 273 ‒ 282.
  4. Y. Zhou, C. Ke, Q. Jiang, S. Shahin, and S. Snapinn, Choosing appropriate metrics to evaluate adverse events in safety evaluation, Therapeutic Innovation and Regulatory Science 49(2015), 398 ‒ 404.

References for Analysis of Data from Spontaneous Reporting Systems - No Abstract

  1. A. L. Gould, T. C. Lystig, Y. Lu, H. Fu, and H. Ma, Methods and issues to consider for detection of safety signals from spontaneous reporting databases: A report of the DIA Bayesian Safety Signal Detection Working Group, Therapeutic Innovation and Regulatory Science 49 (2015), 65 ‒ 75.
  2. M. Hauben, C. Zou, E. Whalen, W. Wang, and L. H. Zhang, A pilot study on the feasibility of using p-plots for signal detection in pharmacovigilance, Statistics in Biopharmaceutical Research 7 (2015), 25 ‒ 35.
  3. N. Hu, L. Huang, and R. C. Tiwari, Signal detection in FDA AERS database using Dirichlet process, Statist. Med. 34 (2015), 2725 ‒ 2742.
  4. L. Huang, T. Guo, J. N. Zalkikar, and R. C. Tiwari, A review of statistical methods for safety surveillance, Therapeutic Innovation and Regulatory Science 48 (2014), 98 ‒ 108.

 

References for Monitoring of Safety Data – Journal Articles, No Abstracts

  1. G. Ball, Continuous safety monitoring for randomized controlled clinical trials with blinded treatment information Part 4: One method, Contemporary Clinical Trials 32 (2011), S11 ‒ S17.
  2. K. Kashiwabara, Y. Matsuyama, and Y. Ohashi, A Bayesian stopping rule for sequential monitoring of serious adverse events, Therapeutic Innovation and Regulatory Science 48(2014), 444 ‒ 452.
  3. S. Wen, G. Ball, and J. Dey, Bayesian monitoring of safety signals in blinded clinical trial data, Ann Public Health Res 2 (2015), 10 ‒ 19.
  4. B. Yao, L. Zhu, Q. Jiang, and H. A. Xia, Safety monitoring in clinical trials, Pharmaceutics 5 (2013), 94 ‒106.