Randomised controlled trials for testing Ebola treatments are
unethical say experts
15 October 2014
A group of leading health experts have urged the deployment of alternative
trial designs to fast-track the evaluation of new Ebola treatments
to suit the urgency of the crisis.
In a letter to The Lancet, 17 senior health
professionals and medical ethicists, from Africa, Europe, and USA,
argue that the lack of effective treatment options for Ebola, high
mortality with the current standard of care, and the paucity of
effective healthcare systems in the affected regions means that
alternative trial designs need to be considered.
They write that, “No-one insisted that western medical workers
offered zMapp and other investigational products were randomised to
receive the drug or conventional care plus a placebo. None of us
would consent to be randomised in such circumstances. In cancers
with a poor prognosis for which there are no good treatments,
evidence from studies without a control group can be accepted as
sufficient for deployment, and even for licensing by regulators,
with fuller analysis following later. There is no need for rules to
be bent or corners to be cut: the necessary procedures already
exist, and are used.”
“We accept that RCTs can generate strong evidence in ordinary
circumstances; not, however, in the midst of the worst Ebola
epidemic in history”, they conclude. “The urgent need is to
establish whether new investigational drugs offer survival benefits,
and thus which, if any, should be recommended by WHO to save lives.
We have innovative but proven trial designs for doing exactly that.
We should be using them, rather than doggedly insisting on gold
standards that were developed for different settings and purposes.”
Clement Adebamowo et al. Randomised controlled trials for Ebola:
practical and ethical issues. The Lancet, published online 10
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