Clinical Trial Patients Often Kept in the Dark
Clinical Trial Patients Often Kept in the Dark
Fri Dec 6, 1:29 PM ET
By Stephen Pincock
LONDON (Reuters Health) - Many people who take part in clinical trials never
find out whether they were treated with the new medication being studied or just
a dummy drug, according to researchers who say scientists should treat patients
more like participants than subjects.
In certain clinical trials, researchers give some patients the experimental
treatment and some an inactive placebo--but make sure that neither the patients
nor the doctors themselves know who is given which. This is an important
technique employed to avoid bias in interpreting results and to establish just
how well the drug really works.
To see whether investigators told the participants what they had been given at
the end of the study, doctoral student Zelda Di Blasi and colleagues from the
University of York, UK, surveyed 107 scientists who had conducted these
"placebo-controlled, randomized" trials.
"Participants have less than a 50% chance of being informed of their treatment
allocation to placebo at the end of a trial," they report in the British Medical
Journal. Overall, 55% of the researchers said they didn't tell any of their
patients, or only told those who specifically asked.
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, there's a chance that telling people they were given a
placebo could have detrimental effects. In some patients it could disrupt the
"placebo effect" in which patients given the dummy drug actually begin to feel
better, the researchers explain.
Considering how much the research community has focused on whether it is ethical
to give people placebo, the issue of telling patients at the end of the study
has received scant attention, Di Blasi and colleagues said. They suggest that
the area deserves more research.
SOURCE: British Medical Journal 2002;325:1329-1332.
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