Compliance revisited: pharmaceutical drug trials in the era of the contract research organization.
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.
Jonvallen
Petra
P
Luleå University of Technology, 971 87 Luleå, Sweden. petra.jonvallen@ltu.se
D001291:Attitude of Health Personnel; D002985:Clinical Protocols; D002986:Clinical Trials as Topic / Q000379:methods / Q000451:nursing / Q000523:psychology; D003284:Contract Services / Q000458:organization & administration*; D003628:Database Management Systems / Q000458:organization & administration; D004046:Dietetics; D004345:Drug Industry / Q000458:organization & administration*; D006785:Hospitals, University; D006801:Humans; D008505:Medical Staff, Hospital / Q000523:psychology; D055118:Medication Adherence / Q000523:psychology*; D009042:Motivation; D024802:Nurse's Role / Q000523:psychology; D009723:Nurse-Patient Relations; D015404:Nursing Methodology Research; D009741:Nursing Staff, Hospital / Q000458:organization & administration / Q000523:psychology*; D009765:Obesity / Q000188:drug therapy / Q000451:nursing / Q000523:psychology; D010348:Patient Care Team / Q000458:organization & administration; D011332:Privatization / Q000458:organization & administration; D011795:Surveys and Questionnaires; D013548:Sweden