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What would you choose if it were you? Aissatou TOURE.

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Presentation on theme: "What would you choose if it were you? Aissatou TOURE."— Presentation transcript:

1 What would you choose if it were you? Aissatou TOURE

2 RCT or not RCT for clinical trials of experimental Ebola treatment? ?

3 RCT or not RCT for clinical trials of experimental Ebola treatment? That is the question.

4 Panel on Adaptive Trial Design Aissatou TOURE

5 Arguments in favor or against conventional methodology Dealing with an uncontrolled disease with such a high mortality rate makes necessary to get out of methodological (and mental) rigidity to take other paths Feasibility of RCT in the specific context : o Issues of social and political acceptability o Untrustness /rumors effective treatments are only for foreign people from developed countries Ebola has been deliberately introduced 100% of people involved in the trial would get the “treatment” Only/best scientifically sound methodology capable of attesting of the efficacy of potential treatments against EVD No certainty on effectiveness (some limited data on safety) The more rapid way to know if treatments are effective and consequently to not waste money in using ineffective treatments Greater numbers of people would have 50% “chance” to be in the “treatment“ group PROCONS

6 Beyond theories and methodology debates, if you were infected by the Ebola virus and knew of a potential treatment that has successfully gone through safety phase I where the toxicity has been proved to be weak, would you rather stick to supportive care to fight through the disease or would you be willing to take your chance with a treatment that might offer an additional chance of surviving even thought the outcome might be uncertain?

7 Trying to guess your thoughts Since acute toxicity was found weak enough to move on to the next test phase, the argument of the uncertainty about the effectiveness of this treatment might probably not prevail and side effects consideration would likely be relegated far behind. A legitimate desire to stay alive might be stronger than side effects management concerns. This option would be even stronger if you had suffered the lost of several of your loved ones taken by the disease.

8 And You??? When there is nothing else than supportive care the people sick with Ebola might accept the situation but if there is a slightest hope of a treatment probably very few would accept to be part of the control group. In such a situation would You do/think otherwise?

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