Event

Study designs utilizing external control arms have been suggested as a methodological approach to be able to efficiently assess outcomes in oncology studies using real-world and observational evidence. Although randomized control trials (RCTs) are considered the gold standard, you will hear from physicians, clinical trialists, statisticians and other real-world research experts on their perspective of current and future applications of synthetic controls to enhance development and increase knowledge of new oncology treatments. They will address challenges faced by the pharmaceutical industry with clinical trials and the potential benefits that may be addressed with external controls, including lower costs, increased efficiency, time savings and potential ways to introduce real-world data elements for regulatory decisions. Our experts will address:

1. What are External Control studies? How are they designed? And how are they beneficial in clinical development to biopharma?
2. Clarifying industry “definitions” surrounding external controls
3. Addressing challenges with the eligibility criteria of oncology clinical trials
4. Considerations of using real-world data for oncology external control studies
5. Describe previous use cases and potential future uses and applications