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

doi:10.1136/bmj.324.7334.419

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What to do about poor clinical performance in clinical trials

Su Mason, joint heada,
Jon Nicholl, directorb,
Richard Lilford (r.j.lilford@bham.ac.uk), professor of clinical epidemiologyc

^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
1 Heron Way, Horsham RH13 6DF
Guy's Hospital, London SE1 9RT

Correspondence to: Professor Lilford

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.

Summary points

Guidelines on research governance from the Department of Health emphasise the importance of patient safety in trials

We suggest that healthcare organisations should make the trial management team responsible for monitoring safety through statistical analysis

Taking action on suboptimal results, however, remains the institution's responsibility

The rules for monitoring and responding to suboptimal performance should be made clear to everyone in advance

Should we monitor, and who should do it?

If neither the host organisation, nor the trial team, takes responsibility for monitoring performance then patients are left with no protection against substandard practice.2 We are aware of the dangers of applying a higher standard of scrutiny to clinical trials than to routine practice, but clinical trials often involve a relatively new treatment (such as an innovative surgical operation) where outcomes vary by skill. 3 4 With any new treatment it is appropriate to scrutinise outcomes—whether or not the treatment is part of a …