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The Anti-Sintilimab Guidance? US FDA Gives Advice On Oncology Multiregional Trials

 
• By Sue Sutter

Studies should enroll a representative subgroup of US patients based on the incidence or prevalence of cancer in the US, and the comparator arm should use the US standard of care when possible, the FDA says in draft guidance.

Globe and stethoscope
The FDA released new advice on designing and conducting multiregional trials for oncology drugs. • Source: Shutterstock

Multiregional clinical development programs to support US Food and Drug Administration approval of oncology drugs should enroll a representative subgroup of US participants adequate to enable a robust assessment of safety and efficacy, new draft guidance states.

Key Takeaways

  • Multiregional clinical development programs should enroll a representative subgroup of US patients based on the incidence or prevalence of cancer in the US, a new draft guidance states.

  • The comparator arm in the studies should reflect the US standard of care when possible

To ensure adequate regional representativeness, the agency recommends a strategic allocation approach based in part on the incidence or prevalence of the cancer in the US, with regions characterized on

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