Patients' interests: paramount in randomised trials

doi:10.1136/bmj.330.7481.44-a

BMJ 2005;330:44-45 (1 January), doi:10.1136/bmj.330.7481.44-a

Letter

Patients' interests: paramount in randomised trials

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

EDITOR—Patients and the public recognise the need forlarge randomised trials. Trialists must also recognise the responsibilitiesthey owe to their study participants. There has been some debateon whether these responsibilities are always fully discharged.

The early stopping of the MA17 trial, with data released tothe media before the trial participants or health professionalshad been given time to assess the implications, led to speculationin the medical press about how far patients' interests werebeing considered.¹ Similarly, recent articles have alleged thatseveral pharmaceutical companies may have withheld product safetydata, ranging from harmful effects of paroxetine in adolescents,to cardiovascular events associated with rofecoxib, with consequentspeculation about the possibility of similar adverse effectsfrom other COX-2 inhibitors.^{2 3}

Sir Tom McKillop, the chief executive officer of AstraZeneca,said: "If we put consumer protection as the only thing the regulatorneeds to worry about, that . . . [Full text of this article]

Tony Stevens, consumer liaison lead

t.stevens@ncrn.org.uk, National Cancer Research Network, Cookridge Hospital, Leeds LS16 6QB

Roger Wilson, chair, National Cancer Research Institute Consumer Liaison Group

National Cancer Research Network, Cookridge Hospital, Leeds LS16 6QB