Randomized controlled trials test new drugs using various debiasing devices to prevent participants
from manipulating the trials. But participants often dislike controls, arguing that they impose a
paternalist constraint on their legitimate preferences. The 21st Century Cures Act, passed by US
Congress in 2016, encourages the Food ...
Randomized controlled trials test new drugs using various debiasing devices to prevent participants
from manipulating the trials. But participants often dislike controls, arguing that they impose a
paternalist constraint on their legitimate preferences. The 21st Century Cures Act, passed by US
Congress in 2016, encourages the Food and Drug Administration to use alternative testing methods,
incorporating participants’ preferences, for regulatory purposes. We discuss, from a historical
perspective, the trade-off between trial impartiality and participants’ freedom. We argue that the only
way out is considering which methods improve upon the performance of conventional trials in
keeping dangerous or inefficacious compounds out of pharmaceutical markets
