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Real-world evidence (RWE) offers the potential to serve as a valuable tool in regulatory decision-making, offering insights derived from the real world that can complement traditional clinical trials. By capturing data from diverse sources such as electronic health records, patient registries, and insurance claims, RWE may help to streamline the clinical development process, reducing time and cost, while adding important information to the benefit-risk assessment. Despite these promising benefits, the full potential of RWE has yet to be fully realized due to challenges related to the underlying real-world data (RWD) that must be fit-for-purpose, controlled for bias, acquired and analyzed with statistical rigor, and maintained in a GCP compliant manner.
Regulatory agencies are working to ensure that guidelines clearly define acceptable practices for deriving and using RWE in their decision-making. For example, since 2017 FDA has been supporting the incorporation of RWE into regulatory evaluations with educational initiatives such as webinars that review best practices, present case studies of successful applications, and offer guidance on the development and use of RWD in various types of guidance meetings.
👉 The Latest RWE Views by FDA
The FDA’s most recent webinar on RWE, held in December 2024, focused on accomplishments and forward-looking initiatives regarding its Real-World Evidence Program for drugs and biological products.
John Kirk, Principal Regulatory Strategist at Veristat, attended the webinar. Watch John’s highlights video, in which he shares his insights and takeaways from the FDA webinar, covering:
- A historical context of RWE and its applications in regulatory submissions
- The increasing trend of its use in new drug applications (NDAs) and biologics license applications (BLAs)
- The importance of data integrity, the need for rigorous statistical analysis, and the growing recognition of RWE in various therapeutic areas, including rare diseases and oncology
“When the FDA assesses the real-world evidence for use in regulatory decision making, the lens they look through to assess analyses of these data will be equivalent to what they would use when they look at data from randomized clinical trials. Time is saved by using data that already exists, for sure, rather than conducting clinical trials. However, the investment is on the backend — creating a viable data set in terms of adequate matching to clinical trial data, addressing missing values, controlling for bias, maintaining data integrity, and other factors.”
John Kirk
Principal Regulatory Strategist at Veristat
By collaborating early in the trial design process, Veristat experts assist our sponsors in evaluating the suitability of real-world data sources, ensuring continual data integrity, and implementing the most current best practices for integrating real-world evidence into their regulatory submissions.
Get in Touch with Veristat
Want to speak to John and the Veristat team to determine if real-world evidence can enhance your clinical trial outcomes and support your regulatory strategy?
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