A group of independent scientific experts convened by the WHO for the purpose of evaluating investigational therapeutics for Ebola virus disease (EVD) during the current outbreak, 17 May 2018 Experts:
Dr. Edward Cox (Chair), Dr. Annick Antierens , Dr. Sina Bavari, Dr Gail Carson, Dr. Marco Cavaleri, Dr. Rick Davey, Dr. Robert Fowler, Prof. Stephan Guenther, Prof. Stuart Nichol, Dr. Tim O’Dempsey, Prof. Ross Upshur, Prof. Jean-Jacques Muyembe* , Prof. Steve Ahuka Mundeke*, Dr. Daniel Bausch* (*Unable to attend but reviewed the statement prior to its finalization)
There are many pathogens for which no proven effective intervention exists. For some pathogens there may be interventions that have shown promising safety and efficacy in the laboratory and in relevant animal models but that have not yet been evaluated for safety and efficacy in humans. Under normal circumstances, such interventions undergo testing in clinical trials that are capable of generating reliable evidence about safety and efficacy. However, in the context of an outbreak characterized by high mortality, it can be ethically appropriate to offer individual patients investigational interventions on an emergency basis outside clinical trials. The WHO developed an ethical framework known as Monitored Emergency Use of Unregistered Interventions (MEURI1.) which established the following criteria to be met for access to investigational therapeutics for individual patients outside of clinical trials:
1) no proven effective treatment exists;
2) it is not possible to initiate clinical studies immediately;
3) data providing preliminary support of the intervention’s efficacy and safety are available, at least from laboratory or animal studies, and use of the intervention outside clinical trials has been suggested by an appropriately qualified scientific advisory committee on the basis of a favourable risk–benefit analysis;
4) the relevant country authorities, as well as an appropriately qualified ethics committee, have approved such use;
5) adequate resources are available to ensure that risks can be minimized;
6) the patient’s informed consent is obtained; and 7) the emergency use of the intervention is monitored and the results are documented and shared in a timely manner with the wider medical and scientific community.
