Statistical Practices of Safety Monitoring: An Industry Survey
Michael W Colopy1, Robert Gordon2, Faiz Ahmad3
11 Statistical Sciences & Innovation, UCB BioSciences Inc, Research Triangle Park, NC, USA.
Abstract:
The Biopharmaceutical Section of the American Statistical Association (ASA) formed a Safety Monitoring Working Group to strengthen collaborations between biostatisticians and safety scientists. The task began by surveying current needs and practices regarding available statistical safety tools and methods, regulatory guidance, and processes needed to support their implementation. The goal is for biostatisticians to become fully engaged safety team members by having the necessary safety skill set including appropriate methodology, regulatory guidance and access to appropriate tools. In this publication, we will discuss our survey results that reveal current practices at 22 pharmaceutical companies and demonstrate how the survey instrument can be used to map an action plan for meeting the demand for improved quantitative safety monitoring.
More Related Videos
08:53Safety Precautions and Operating Procedures in an ABSL-4 Laboratory: 2. General Practices
Published on: October 3, 2016
07:59Using Practice Testing, Public Speaking, and Source Monitoring to Examine the Influences of Learning Strategies and Stress on Episodic Memory
Published on: June 14, 2019
Related Concept Videos
Survey Safety
Surveys
Statistical Significance
Introduction to Surveying, Plane Surveying and Geodetic Surveys
Errors and Mistakes in Surveying
Types of Surveys
