Brief History

The ASA Biopharmaceutical Safety Working Group (SWG) was initially created in 2014.  It started with a working group on “Safety Strategies and Analysis” in 2014, which led to the creation of the Safety Monitoring Working Group in the fall of 2015, with mission “to help empower the biostatistics community to better enable qualitative and quantitative safety monitoring”. Founding co-chairs were Dr Olga Manchenko and Dr Qi Jiang; they were followed by Judy Li and William Wang.

As explained in an article by Judy Li et al. in AMSTAT NEWS, 1 July 2019, (page 18),  the working group was formed as a response to the trend away from individual case review towards aggregate analysis of safety data to determine if an event was a reportable “SUSAR”. That called for the further development of statistical methodology for blinded monitoring and aggregate analyses across clinical trials in the same program. At the same time, it was clear that a more interdisciplinary approach had to be established that considered both qualitative medical and quantitative statistical thinking. Therefore, in 2017 the working group expanded into an interdisciplinary working group and kept a strong focus on this aspect since then. Jim Buchanan and Mengchun Li served as non-statistical co-chairs and significantly contributed to the success of the working group.

The working group also had members from the beginning.  This involvement was formalized and acknowledged by a public-private partnership (PPP) agreement with the FDA that was signed in early 2021.