Most Clinical Trial Participants Not Told of Treatment Allocation at...

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Most Clinical Trial Participants Not Told of Treatment Allocation at End of

Study

LONDON (Reuters Health) Dec 06 - Many people who take part in clinical

trials never find out whether they were treated with the active medication

being studied or just a placebo, according to investigators who say

researchers should treat patients more like participants than subjects.

To see whether researchers told the participants what they had been given at

the end of a randomised, blinded trial, doctoral student Zelda Di Blasi and

colleagues from the University of York, UK, conducted a survey of 107

trialists.

Overall, 55% of the researchers said they didn't tell any of their patients,

or only told those who specifically asked, according to the report in the

British Medical Journal for December 7.

The main reasons for not informing participants were that the investigators

never considered this option or that they wanted to avoid biasing results

during the follow-up of patients after the study.

" Patients need to be treated as participants, rather than subjects, by

increasing their involvement in the trial process, " Di Blasi's team writes.

Getting patients more involved improves the quality of studies in important

ways, they point out.

However, they add that there's a chance that telling people they were given

a placebo could have detrimental effects. In some patients it could disrupt

any " placebo response. "

Considering how much the research community has focused on whether it is

ethical to give people a placebo, the issue of telling patients of their

allocation at the end of the study has received scant attention, Di Blasi

and colleagues said. They suggest that the area deserves more research.

BMJ 2002;325:1329-1332.