Mason, S., Nicholl, J. and Lilford, R. (2002) What to do about poor clinical performance in clinical trials. BMJ, 324 (7334). pp. 419-420. ISSN 0959-535XFull text available as:
Available under licence : See the attached licence file.
The performance of individual clinicians is being monitored as never before. Su Mason and colleagues discuss the implications of this for clinical trials and recommend what should happen if during a trial the performance of one clinician or one centre is identified as being particularly poor. Tom Treasure, a surgeon, wants the monitoring to be done fairly and to take account of the complexities of clinical practice; and Heather Goodare, a patient, wants to be told when things go wrong.
The Department of Health in England has issued guidelines for research governance stating that healthcare organisations remain responsible for the quality of all aspects of patients' care whether or not some aspects of the care are part of a research study.1 We discuss how this obligation can be met in multicentre trials, given that data on the performance of clinicians are held by the trial management team, not by the host organisation.
|Copyright, Publisher and Additional Information:||© 2002 BMJ Publishing Group.|
|Institution:||The University of Sheffield, The University of Leeds|
|Academic Units:||The University of Sheffield > Faculty of Medicine, Dentistry and Health (Sheffield) > School of Health and Related Research (Sheffield) > Health Services Research (Sheffield)
The University of Leeds > Faculty of Medicine and Health (Leeds) > Institute of Molecular Medicine (LIMM) (Leeds) > Section of Clinical Trials Research Unit (Leeds)
|Depositing User:||Repository Officer|
|Date Deposited:||28 Nov 2008 13:43|
|Last Modified:||16 Jun 2014 19:10|