Precision Medicine is fundamentally impacting the drug development process. But the promise of precision medicine also comes with great challenges: patient recruitment, protocol optimization and the logistics hurdles. Understanding recruiting patients by their genetics or biomarkers requires physicians to be well educated on both specific trial requirements and the intricacies of personalized medicine. Add the lack of regulatory guidelines or modifications needed to meet government approvals, and the difficulty of finding enough patients globally to meet protocol requirements, and it’s clear precision medicine requires a new approach based on structure methodology – one that is optimized for time, cost and risk.

We prepared a precision medicine checklist to help understand the challenges and opportunities running precision medicine trials.

The checklist covers the following:

• Ensuring your protocol is compliant with known regulatory positions, and being adaptable to an evolving approval process
• Optimizing your protocol for the best balance between finding the patients you need and making sure your final data is valid and ready for submission