It is no longer enough to prove product quality, safety and efficacy, payers now want to know whether benefits will translate into the wider population of patients.
Payers also now want to see how the product compares to existing treatments rather than a placebo.
At PAREXEL we have found the following practices are the key to success:
• Answer the question with design
• Select sites that mirror reality
• Enrol broadly
• Monitor smartly
• Keep it simple
• Embrace the future