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The Babel of Drugs: On the Consequences of Evidential Pluralism in Pharmaceutical Regulation and Regulatory Data Journeys
Data Journeys in the Sciences
Throughout the last century, pharmaceutical regulators all over the world have used various methods to test medical treatments. From 1962 until 2016, the Randomized Clinical Trial (RCT) was the reference test for most regulatory agencies. Today, the standards are about to change, and in this chapter we draw on the idea of the data journey to illuminate the trade-offs involved. The 21st Century Cures Act (21CCA) allows for the use of Electronic Health Records (EHRs) for the assessment ofdoi:10.1007/978-3-030-37177-7_11 fatcat:rfzxwahu5reejcjkxmutovchg4