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

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# What to do about poor clinical performance in clinical trials {#article-title-2} 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 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 …