Randomised controlled trials for testing Ebola treatments are unethical say experts15 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.” Reference Clement Adebamowo et al. Randomised controlled trials for Ebola:
practical and ethical issues. The Lancet, published online 10
October, 2014. Further information New forecasts show Ebola infections could reach 1.4 million by January Scale of current Ebola outbreak makes previous models for predicting spread useless International Ebola response "Totally, and lethally inadequate" Scripps labs studying the structure of antibodies to Ebola virus
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