Effective Integration of PRO Strategy and Execution within the Drug Development Framework
Do not be discouraged by the requirements of the FDA PRO Guidance to Industry. With proper planning, PRO label claims are an attainable goal! While the mantra has been that PROs are just like any other endpoint used to support a claim, the reality is that much education and process improvement has been required to emphasize the investment of time and integration of PRO strategy and execution within the “Learn and Confirm” drug development framework. To see the presentation click below.