In July, the FDA’s Oncology Center of Excellence published three updated clinical trial eligibility guidance documents.
The move comes after the agency’s April announcement that it was conducting its first real-time clinical trials in partnership with Houston-based University of Texas MD Anderson Cancer Center, Philadelphia-based University of Pennsylvania, AstraZeneca, Amgen and Paradigm Health. The real-time clinical trial model allows the FDA to review safety signals as a trial is being conducted to enhance safety monitoring and increase efficiency.
The Oncology Center of Excellence’s July updates provide recommendations for selecting appropriate laboratory values as trial eligibility criteria to avoid unjustified exclusions of trial participants; expanding eligibility criteria to include patients with a wider range of performance status; and the appropriate use of washout periods and concomitant medication exclusions.
Read the full updated guidance documents here.
At the Becker's Perioperative Summit, taking place September 14–15 in Chicago, perioperative leaders and healthcare executives will focus on improving operating room efficiency, enhancing patient safety, optimizing staffing and driving innovation across surgical services. Apply for complimentary registration now.
