A cross-disciplinary collaboration working to improve the content and implementation of clinical trial safety analyses for medical research, leading to better data interpretations and increased efficiency in the clinical drug development and review processes.
Working Group Leads
Mary Nilsson:  Research Advisor | Greg Ball:  After graduating from Northwestern University with a bachelor’s in economics, Greg served in the Navy for 4 years and taught high school math and physics for 5 years, before going back to school to get a master’s in applied statistics from Purdue University. Eventually, while working as a statistician, he earned his PhD in biostatistics from the University of Texas Health Science Center. His current research on blinded safety monitoring procedures emerged from his early work at academic medical centers (MD Anderson and the Methodist Hospital) and CROs (Westat and Quintiles), developed into his college dissertation and continues to be developed in collaboration with statistical and clinical scientists from several pharmaceutical companies (Astellas, AbbVie and Merck). Greg established, with Bill Wang, the ASA Biopharm Safety Monitoring working group and is pioneering the joint DIA-ASA Interdisciplinary Safety Evaluation (DAISE) scientific working group, to advocate for aggregate safety assessments and cross-disciplinary scientific engagement. |
|---|