Compliance revisited: pharmaceutical drug trials in the era of the contract research organization

Nursing Inquiry 16 (4):347-354 (2009)
  Copy   BIBTEX

Abstract

Over the past decade, the management of clinical trials of pharmaceuticals has become a veritable industry, as evidenced by the emergence and proliferation of contract research organizations (CROs) that co‐ordinate and monitor trials. This article focuses on work performed by one CRO involved in the introduction of new software, modelled on industrial production processes, into clinical trial practices. It investigates how this new management technique relates to the work performed in the clinic to ensure that trial participants comply with the protocol. Using an analytical distinction between ‘classical’ management work and invisible work, the article contextualizes the meaning of compliance in the clinic and suggests that the work involved in producing compliance should be taken into consideration by those concerned with validity of trials, as clinical trials are put under private industrial management. The article builds on participant observation at a Swedish university hospital and interviews the nurses, dieticians, doctors and a software engineer, all part of a team involved in pharmaceutical drug trials on a potential obesity drug.

Links

PhilArchive



    Upload a copy of this work     Papers currently archived: 93,098

External links

Setup an account with your affiliations in order to access resources via your University's proxy server

Through your library

Similar books and articles

Institutional mistrust in the organization of pharmaceutical clinical trials.Jill A. Fisher - 2008 - Medicine, Health Care and Philosophy 11 (4):403-413.
Outsourcing Clinical Trials to Latin America: Causes and Impact.Antonio Ugalde & Nuria Homedes - 2019 - In Eduardo Rivera-López & Martin Hevia (eds.), Controversies in Latin American Bioethics. Cham: Springer Verlag. pp. 115-144.

Analytics

Added to PP
2014-01-26

Downloads
8 (#1,344,496)

6 months
2 (#1,259,626)

Historical graph of downloads
How can I increase my downloads?

Citations of this work

No citations found.

Add more citations