Quantitative patient preference studies set the benefit-risk bar before phase 3

Discrete choice experiments and best-worst scaling quantify how patients trade benefits against harms and burdens. Regulators (FDA CDRH, EMA) have accepted such data in medical devices and some drugs. The proposal is that for each new indication, a preference study defines the minimum clinically important benefit and acceptable toxicity profile, which is then written into the phase 3 design and the regulatory review.