Prioritizing preferences

The realization that patients have distinct preferences about the trade-offs and risks inherent in medical decisions -- and that their choices are frequently different from those physicians or regulators would make -- has mobilized FDA, Congress and industry to begin to embed patient input into the development and evaluation of medical products.

FDA has concluded that patient preference information is necessary to inform regulatory decision-making, and in some cases may be the only way to enable an approval when benefit-risk trade-offs are uncertain...