Safety Scientific Working Group

This working group will examine a more nuanced ranking of strength of evidence generated by real world data among non-randomized and randomized, prospective and retrospective designs throughout different stages of drug development, and develop a structured and principled approach to connect and integrate the multi sources of data for the purposes of risk and benefit evaluation.

1. Task Force 1: WS3-TF1 is an ASA safety working group task force on the application of ICH E9 (R1) estimand framework in post-marketing safety evaluation. The ICH E9(R1) recently established guidelines for the use of ‘estimands’ in clinical trials. The estimand framework provides a structured way of specifying what is being measured and estimated in a study and may also lead to better design of clinical trials and clearer communication between all relevant stakeholders. We would like to evaluate whether the “safety estimand” framework can be adapted for use in post-market safety studies and a proposal for how this may be accomplished. . If you would like to learn more or join this task force, please contact Yong Ma (yong.ma@fda.hhs.gov) and William Wang (William_wang@merck.com)
   
   
2. Task Force 2:WS3-TF2 is an ASA safety working group task force looking at design and statistical considerations for the pharmacoepidemiologic safety studies. This effort is a collaboration with epidemiology, statistics, and pharmacovigilance in alignment with the development of ICH M14 Expert Working Group. We look to understand the existing study design options, how the advanced causal inference methods can be applied, and how to interpret the statistical evidence presented in the data. The works we are doing can help to establish a common language and bridge statisticians, epidemiologists, and safety physicians in applying statistician concepts (for example, estimand) to the design of pharmacoepidemiologic safety studies. If you would like to learn more or join this task force or our other workstreams, please contact Li-An Lin (Lian.lin@modernatx.com), Yong Ma (yong.ma@fda.hhs.gov) and William Wang (William_wang@merck.com)
   
   
3. Task Force 3: WS 3 TF 3 is an ASA safety working group task force looking at safety design/analysis methods in RCT and RWE settings. Methods from epidemiology, statistics, and machine learning sometimes get applied to safety questions. We look to understand how these methods are currently used and could potentially better address the causal aspects of questions in drug safety. The work of many stakeholders can benefit from our work and vice versa. If you would like to learn more or join this task force or our other workstreams, please contact Ed Whalen (ed.whalen@pfizer.com), Birol Emir (Birol.Emir@pfizer.com) Yong Ma (yong.ma@fda.hhs.gov) and William Wang (William_wang@merck.com)