The use of RWD/RWE in drug development continues to evolve. Despite FDA draft guidance, there are few examples of successful and unsuccessful uses of RWD/RWE in clinical trials to draw upon, although it is growing daily.

Therefore, it’s important to draw upon expertise and ensure that trial investigators are using data standards the FDA will accept and to actively engage with the agency in the process.

This playbook further refines an understanding of RWD and RWE, ways in which it can be used in post-marketing and pre-marketing activities, like complementing clinical trials, deepening safety data and testing drugs for secondary indications. The playbook also:

• Describes the conditions where RWD/RWE is effective and ineffective 
• Offers case studies for both
• Highlights how designing and leveraging RWD/RWE as a service product can streamline clinical trials

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