BMJ 2002;324:419-421 ( 16 February )

Education and debate

    What to do about poor clinical performance in clinical trials
    Commentary: Of course patients should be told
    Commentary: The surgeon is only one factor

What to do about poor clinical performance in clinical trials

Su Mason, joint head aJon Nicholl, director bRichard Lilford, professor of clinical epidemiology c

a Northern and Yorkshire Clinical Trials and Research Unit, University of Leeds, Leeds LS2 9NG, b Medical Care Research Unit, University of Sheffield, Sheffield S1 4DA, c Department of Public Health and Epidemiology, University of Birmingham, Birmingham B15 2TT

Correspondence to: Professor Lilford (r.j.lilford@bham.ac.uk)

The first 150 words of the full text of this article appear below.

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 . . . [Full text of this article]


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