A: ALWAYS START WITH THE END IN MIND and then focus. Invest in the best, most experienced statistician you can find. Focus on specific data to support your primary and hierarchical key secondary endpoints and your criteria for success. Only invest in the investigators who know how to optimize enrollment with the right subjects. Provide those investigators with the resources they need to be successful. Train everyone involved in the trial and reinforce study conduct methods continuously. If your product has any unique elements for use or administration, send a qualified observer to ensure the investigator is administering the product correctly for the first few subjects.
MARY ROSE KELLER
Mary Keller is VP of clinical operations at Heron Therapeutics and has 30+ years of experience in clinical development strategy and execution of global Phase 1 to 4 clinical trials for drug, biologic, and diagnostic products.