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.
Therapeutic Innovation & Regulatory Science
|July 12, 2018
Summary
The American Statistical Association
Area of Science:
- Biostatistics
- Pharmacovigilance
- Drug Safety
Background:
- Biopharmaceutical Section of the American Statistical Association (ASA) formed a Safety Monitoring Working Group.
- Goal is to strengthen collaborations between biostatisticians and safety scientists.
- Focus on enhancing quantitative safety monitoring in drug development.
Purpose of the Study:
- Survey current needs and practices in statistical safety tools and methods.
- Assess regulatory guidance and implementation processes.
- Identify skill gaps for biostatisticians in safety monitoring.
Main Methods:
- Conducted a survey across 22 pharmaceutical companies.
- Assessed availability and use of statistical safety tools and methods.
- Evaluated regulatory guidance and implementation processes.
Main Results:
- Revealed current practices in quantitative safety monitoring.
- Identified areas for improvement in statistical methodology and tools.
- Highlighted the need for enhanced biostatistician engagement in safety teams.
Conclusions:
- Survey results provide a benchmark for current practices.
- The survey instrument can guide action plans for improved safety monitoring.
- Biostatisticians require specific skills and tools to be effective safety team members.
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