Online Program

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Wednesday, September 25
Wed, Sep 25, 8:30 AM - 9:45 AM
Regulatory Experiences and Approaches of Using Historical Controls and Real-World Data in Product Development and Approval

Use of Historical Controls and Real-World Data for Oncologic Drugs and Biologics (301010)

*Pallavi Shruti Mishra-Kalyani, FDA 

Keywords: Oncology, Real World Data, Real World Evidence, Historical Controls, External Controls

The establishment of comparative efficacy using data from sources other than traditional randomized control trials growing interest in the scientific community. Additionally, FDA has launched several initiatives to encourage the use of real-world evidence to support the regulatory actions for drugs and biologics. We will discuss the current experiences using real-world evidence for approvals of oncology drugs and biologics, as well as possible use of external controls or real-world data in support of evidence of treatment efficacy.