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Key Takeaways

• There is growing interest in the value of using real world data and real world evidence to support label expansions and approvals.
• RWE can provide information not typically learned from randomized clinical trials (RCTs), and helps address key questions that are relevant to patients, regulators, and healthcare providers.
• In 2018, the FDA released its Framework for Real World Evidence Program use in evaluating the potential use of RWE to support approval of new indications for drugs already approved, or to help support or satisfy drug post-approval study requirements.
• In Europe, the Heads of Medicines Agencies and the EMA released a joint report in 2019 on their big data taskforce summarizing many areas of interest to better understand RWE and its potential uses.

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