Clinical Trials and the Drive to Material Standardisation

‘Extending the Rails’ or Reinventing the Wheel?

  • Catherine M. Montgomery University of Oxford

Abstract

There have long been calls to reduce the bureaucratization of clinical trials and make them more ‘sensible’, with the focus on approvals and guidelines. Here, I focus on the mundane environments of a multi-centre clinical trial to ask how ‘sensible’ it is to standardize trials at the level of material objects. Drawing on ethnographic data collected in the UK, South Africa and Vietnam, I present three vignettes of material standardisation. While acknowledging some positive effects, I argue that standardising in this way may be antithetical to sustainable and relevant clinical research.  Three dimensions of this are discussed: 1) the external validity of evidence from pragmatic trials 2) the gap between experimentation and implementation and 3) long-term site capacity to conduct research.  Drawing on the literature on ‘situated standardisation’, the paper concludes by suggesting a greater acknowledgement of the need for trials not only to be ‘sensible’ but also ‘situated’.