Articles
Post-Approval Research: Safety Net Or Power Tool?
March 16, 2009
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•Article: Post-Approval Research: Safety Net Or Power Tool?
•Article: Post-Approval Research: Safety Net Or Power Tool?
•Article: Post-Approval Research: Safety Net Or Power Tool?
By Nancy A. Dreyer, MPH, PhD
The method of releasing a new product into the marketplace is a delicate balancing act. A devel-oper naturally wants to release its product ASAP. However, the developer also knows the product has to undergo serious testing before it can safely be made publicly available. Post-approval research is the responsible solution to this dilemma. Also known as phase IV testing, this method allows a product to prove its real-world worth through patient health improvement while simultane-ously demonstrating its long-term safety. This method enables knowl-edgeable practitioners to prescribe the product in confidence, which makes the product more valuable. It also sets up mechanisms to:
- Evaluate product utilization patterns
- Explore market and label expansion opportunities
- Provide a steady pipeline of data for scientific publications and presentations
•Article: Post-Approval Research: Safety Net Or Power Tool?
