Valuations of experimental designs in proteomic biomarker experiments and traditional randomised controlled trials

This article examines the shifting conditions for biomedical knowledge production by studying trends in the design of biomedical experiments. The basic premise of the study is that the very act of establishing a research design entails a process involving a series of valuations where different values are evoked, ordered, and displaced. In focus is the articulation and ordering of what counts as central values in research design for two kinds of biomedical treatment trials, namely the traditional randomised controlled trial (RCT) and the emerging new form of biomarker trials used to assess biomarker/treatment combinations (BTTs). The empirical material consists of textbooks (RCTs) and journal articles (BTTs). We ask how these materials articulate the various scientific, medical, and economic values at play. Among the differences uncovered are a difference in relation to what counts as ethical in relation to prior knowledge, differences in the flexibility in design as well as the valuation of the risk for false positives and false negatives. More broadly, the study shows how textual accounts of different ways of producing knowledge are linked to partly different valuations of ethics, flexibility, and risk as part of establishing the research design of biomedical experiments.