Laura Bothwell

  • Fellowship year:2012-2013
  • University: Columbia University
  • Dissertation Topic/Category: Social-Medical Sciences
  • Dissertation Title: A Social History of the Randomized Controlled Trial
  • In perceived biomedical research wisdom, randomized controlled trials (RCTs) revolutionized post-World War II health research. By blending statistical analysis with the testing of new procedures and interventions, RCTs have enabled investigators to circumvent the influence of a variety of biases on research outcomes so that the effectiveness of various interventions can be ascertained with unmatched levels of confidence. While extant literature addresses the epistemological history of RCTs from the scientific community's perspective, history of medicine would be significantly enhance by a broader social history of RCTs. Similarly, while a plethora of bioethical literature has been written on RCTs and human subject research, we currently lack a historical analysis which ties together ethical shifts over time as they relate to RCTs.

     
    The objective of my dissertation is to describe the key political, economic, and cultural events in the social history of RCTs from the 1950s to the 1990s and to analyze how these events influenced RCTS methodology and norms. I aim to show how large, multi-site RCTs grew out of a Cold War political environment that supported public investment in scientific structures; how post-WWII law influenced the proliferation of RCTS; how politics, culture, and economics influenced shifts in the demographics of RCT research subjects; and how ethical norms both changed and remained consistent in RCTs over time through interaction with broader cultural ethical shifts.