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

Abstract

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 the Food and Drug Administration to use alternative testing methods,incorporating participants’ preferences, for regulatory purposes. We discuss, from a historicalperspective, the trade-off between trial impartiality and participants’ freedom. We argue that the onlyway out is considering which methods improve upon the performance of conventional trials inkeeping dangerous or inefficacious compounds out of pharmaceutical markets.