Part of our discussion surrounding last week’s articles on randomized controlled trials focused on the way this preferred clinical evidence method represents patients. RTCs treat patients as homogenous; they assume differences among patients are going to come out in the wash. In the words of the CRO head quoted by Andriana Petryna, this idealized typifying of patients could be seen as making “ ‘non-existent patients’ come into existence”.
Petryna’s article indicates that the practice of offshoring clinical trials further broadens the gap between drug participants in clinical trials and drug consumers. She notes that the shift towards outsourced clinical trials is partly the result of a drug dependent Western population. Because many potential trial candidates in America and Eastern Europe are often taking three or four drugs, they cannot participate in drug studies. Researchers must look abroad to satisfy demand, testing drugs using ‘naïve’ recruits from populations unaffected by ‘treatment saturation’. Yet, those drugs that successfully pass trial phases are primarily consumed not by those naïve populations, but rather by the treatment saturated populations. The ultimate consumers of the drugs are ineligible as test subjects.
In this case, RCTs exclude their target users because they produce test results that are less statistically significant. Andriana Petryna suggests, however, that the value CROs and evidence based medicine place on statistical significance has resulted in non-existent patients becoming the ideal research candidates.