Abstract
Enhance Your Post-Marketing Trials:
Phase 4 is the fastest-growing area of clinical research today. At an annual
growth rate of 23%, industry investment in post-marketing research is expected
to top $12 billion in 2007. Rampant growth in Phase 4 research should come as
no surprise, however. A changing regulatory environment, growing concerns
about the safety of new medicines, and various uses for large-scale,
real-world data on marketed drugs' safety and efficacy are primary drivers of
the growth seen in the Phase 4 research environment today. Post-marketing
research is an important element of commercialization that enables companies
to expand existing markets, enter new markets, develop and deliver messaging
that directly compares their products with the competition, and secure a niche
position in crowded markets. What' s more, payer groups and regulators are both
requiring more post-marketing data from drug companies.
Given the increasing importance of post-marketing research, continued growth
expected for Phase 4 trials, and mounting competitive pressures, it is
critical for companies to make full use of the information and data available
to them. Phase IV Clinical Trials: Post-Marketing Study Management Structure,
Strategy, and Benchmarks is a comprehensive post-marketing study management
tool designed to provide industry executives with benchmark data and best
practice information to inform key strategic and operational decisions in the
areas of Phase 4:
- Trial management structure and oversight
- Research strategy
- Study design and execution
- Study timelines and cycle times
- Performance metrics and management
- Operational activities
- Trial budgeting and outsourcing
- Trial staffing
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