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Product approval demands real-world evidence

With healthcare payers under increasing amounts of pressure to keep costs down, more and more companies are being asked to provide proof of how their product benefits the ‘real world’. If you fail to provide real-world evidence, it’s highly likely that your product will not reach its full potential.

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 

Article: Today's Gold Standard - Product Approval Demands Real-World Evidence

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