Safety Scientific Working Group

Safety Strategies and Analysis Workstream

  1. Zink RC. (2018). Introduction to the Special Section for Sources of Safety Data and Statistical Strategies for Design and Analysis. Therapeutic Innovation & Regulatory Science 52: 140.
  2. Zink RC, Marchenko O, Sanchez-Kam M, Ma H & Jiang Q. (2018). Sources of safety data and statistical strategies for design and analysis: Clinical trials. Therapeutic Innovation & Regulatory Science 52: 141-158.
  3. Izem R, Sanchez-Kam M, Ma H, Zink RC & Zhao Y. (2018). Sources of safety data and statistical strategies for design and analysis: Post-market surveillance. Therapeutic Innovation & Regulatory Science 52: 159-169.
  4. Marchenko O, Russek-Cohen E, Levenson M, Zink RC, Krukas-Hampel M & Jiang Q. (2018). Sources of safety data and statistical strategies for design and analysis: Real world insights. Therapeutic Innovation & Regulatory Science 52: 170-186.
  5. Ma H, Russek-Cohen E, Izem R, Marchenko O & Jiang Q. (2018). Sources of safety data and statistical strategies for design and analysis: Transforming data into evidence. Submitted to Therapeutic Innovation & Regulatory Science 52: 187-198.
  6. Marchenko O, Jiang Q, Chuang-Stein C, Mehta C, Levenson M, Russek-Cohen E, Liu L, Sanchez-Kam M, Zink RC, Ke C, Ma H, Maca J & Park S. (2017). Statistical considerations for cardiovascular outcome trials in patients with type 2 diabetes mellitus. Statistics in Biopharmaceutical Research 9: 347-360.
  7. Marchenko O, Jiang Q, Chakravarty A, Ke C, Ma H, Maca J, Russek-Cohen E, Sanchez-Kam M, Zink RC & Chuang-Stein C. (2015). Evaluation and review of strategies to assess cardiovascular risk in clinical trials in patients with type 2 diabetes mellitus. Statistics in Biopharmaceutical Research 7: 253-266.

Safety Monitoring Workstream

  1. Colopy M, Duke S, Ball G, Gordon R, Ahmad F, Jiang Q, Wang Wenquan & Wang William. (2016). ASA Biopharm’s Safety Monitoring Working Group: Survey of statisticians, thought leaders and regulatory guidance. JSM Proceedings 3030-3042.
  2. Fries M, Kracht K, Li J, Munsaka M, Sanchez-Kam M, Singh K, Wang W, Whalen E, Zhou K. (2016). Safety monitoring methodology in the premarketing setting. JSM Proceedings 2247-2269.