The trade-off between impartiality and freedom in the 21st Century Cures Act

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