Statistical evidence is pervasive in medicine. In this chapter we will focus on the reliability of randomized clinical trials (RCTs) conducted to test the safety and efficacy of medical treatments. RCTs are scientific experiments and, as such, we expect them to be replicable: if we repeat the same experiment time and again, we should obtain the same outcome (Norton 2015). The statistical design of the test should guarantee that the observed outcome is not a random event, but rather a real effect of the treatments administered. However, for more than a decade now we have been discussing a replicability crisis across different experimental disciplines including medicine: the outcomes of trials published in very prestigious journals often disappear when the experiment is repeated –see for instance Lehrer 2010, Begley and Ellis 2012, Horton 2015).
(2019-01-01) Andreoletti, Mattia; Teira Serrano, David
Over the last decade, philosophers of science have extensively criticized the epistemic superiority of Randomized Controlled Trials (RCTs) for testing safety and effectiveness of new drugs, defending instead various forms of evidential pluralism. We argue that scientific methods in regulatory decision making cannot be assessed in epistemic terms only: there are costs involved. Drawing on the legal distinction between rules and standards, we show that drug regulation based on evidential pluralism has much higher costs than our current RCT-based system. We analyze these costs and advocate for evaluating any scheme for drug regulatory tests in terms of concrete empirical benchmarks, like the error rates of regulatory decisions.
