In March 2012, Nature published a commentary urging the academic community to “raise standards” for preclinical research. They argued that poor quality data was “unquestionably a significant contributor to failure in oncology trials” and that the present situation in clinical research was “reminiscent of the situation in clinical research about 50 years ago.” This commentary catalyzed a series of reforms at the National Institutes of Health that were carried out at lightning speed (for a large federal bureaucracy): by January 2014 NIH Director Francis Collins had publicly committed to a series of reproducibility reforms, and by January 2016 several of these reforms had already come into effect across all institutes and centers. This talk explores the historical circumstances that laid the groundwork for these rapid policy changes by connecting the history of medicine to the history of science. I show how the techniques that evidence-based medicine reformers were adopted and adapted by translational researchers, generating a body of evidence about the quality of rodent studies that was later mobilized by reformers within the NIH. Assessments of the number of authors reporting that their studies had been masked and randomized, for example, allowed reformers to argue that preclinical research was substandard because relatively few practitioners used the specific types of bias-reducing techniques that are common in clinical research. This moment in history is part of a broader story of how conceptions of “quality” developed within the clinical trials ecosystem are being taken up in basic research, and changing the landscape of scientific labor as a consequence. 

Nicole C. Nelson is an Associate Professor in the Department of Medical History and Bioethics at the University of Wisconsin–Madison. Her research examines scientists’ assumptions about the natural world and how these assumptions shape scientific practice. In her book, Model Behavior, she explores how animal behavior geneticists’ beliefs about the complexity of gene action and of psychiatric disorders are reflected in their research with mouse models. For this work she won a First Book Award from the UW–Madison Center for the Humanities.

Nelson also does research on new technologies in oncology research and clinical practice. As an embedded ethnographer in a trial investigating resistance to chemotherapy, she observed researchers as they introduced genomic technologies into existing clinical research routines. Work from this project, conducted in collaboration with Alberto Cambrosio and Peter Keating, has been published in Social Science & Medicine and New Genetics and Society. Currently, she is conducting research with Pilar Ossorio on machine learning algorithms in oncology, where algorithms are now routinely used to estimate a patient’s risk of reoccurrence of their cancer.

Nelson is a Collaborating Editor for the journal Social Studies of Science, where she manages the review process and make decisions on a subset of manuscripts submitted to the journal. She is also on the editorial board for the journal New Genetics and Society, the Journal of the History of Biology, and was the reviews editor at Social Studies of Science.