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Case Study E
Clinical trial of drug for people with Down
Dr E wants to investigate whether a particular drug will improve
the cognitive and learning abilities of people with Down syndrome.
He proposes a randomised, double-blind, placebo-controlled study.
This means that some of the participants would receive the study
drug and some would receive a placebo (for example, a sugar pill).
During the trial, neither the participants nor the researchers
would know who was receiving the drug. Participants would be
required to undergo regular six-hour assessment visits to check
The study drug has already been tested on people without Down
syndrome. That research provided some information about the
possible risks and side-effects of the drug, including that, for
some participants, it increased the incidence of contemplating
suicide. However, there may be other risks or side-effects that
have not yet been discovered. In particular, the effects of the
drug on people without Down syndrome may be different from those on
people with Down syndrome.
It is not known whether the drug will have the desired effect on
cognition or learning (or any other beneficial effects). However,
it is likely that even if the drug did lead to an improvement in
cognition for the research participants, the effect would be
temporary because the drug would not be available to participants
after the conclusion of the trial.
Some adults with Down syndrome may be capable of providing
consent if given appropriate support and information. Those
consumers could then be enrolled in the study in accordance with
ordinary consent principles. Dr E proposes also to enrol
participants who are not able to give consent because the effects
of the drug on those participants may be different. Dr E proposes
to consult with family/whānau/caregivers and, if they express
objections, those participants will not be enrolled.
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