Trial management team should be responsible for patient welfare

Healthcare organisations should make the trial management team responsible for patients' welfare during a trial. Mason and colleagues (p 419) say that the statistician who is responsible for analysing data on interim monitoring could scrutinise the outcome by the clinician or organisation. This would identify clinicians or centres that lie outside the bounds of acceptable practice. However, it should remain the institution's responsibility to take action on suboptimal results. The rules for monitoring and responding to suboptimal performance should be made clear to everyone in advance.

(Credit: A TSIARAS/SPL)

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Relevant Article

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

Su Mason, Jon Nicholl, Richard Lilford, Heather Goodare, and Tom Treasure
BMJ 2002 324: 419-421. [Extract] [Full Text] [PDF]