WHO Releases New Guidance On Ebola Clinical Trials
By Cyndi Root
The World Health Organization (WHO) delivered guidance to the pharmaceutical industry on its new criteria for clinical trials in the treatment of Ebola virus disease (EVD). The guidance was delivered in person by Dr. Martin Friede of WHO and published via video feed and transcribed. Dr. Friede and other members of the Scientific and Technical Advisory Committee for Ebola Experimental Interventions (STAC-EE) met in Geneva. He opened his remarks saying, "Over the last two days we have had a meeting of high level scientists, experts in the Ebola virus, virologists, developers of drugs, pharmacologists, and social scientists, and we have reviewed the data around the drugs that are currently being proposed for treating Ebola."
Dr. Friede said that governments, industry, and academia have tested many drugs against Ebola, but a wide number have shown no activity at all. WHO intends to post these drugs on its website. Lamivudine is one such drug, which, despite the fact there has been no evidence that the drug is effective, has been used in several countries. While WHO and its scientists know which drugs do not work, Dr. Friede says that there is much that is yet unknown. Blood from recovered patients is promising, but scientists do not yet know which components — the blood, the plasma, or the immunoglobulins — actually work.
Ebola Clinical Trials
Dr. Friede said that clinical trials on Brincidofivir and Favipiravir will begin soon, testing for safety and efficacy. A consortium from Belgium, France, and the United Kingdom will conduct a study in Guinea on convalescent whole blood (CWB) and convalescent plasma (CP). Another study in Sierra Leone will prioritize a study of CP but will utilize CWB under a compassionate care provision.
Trial Criteria
In the remarks, WHO pointed out that standards of care vary depending on the country. Therefore, WHO recommends that studies only be carried out at clinical sites that meet a certain standard of care. Facilities that provide a consistently good standard of care are limited in West Africa. Dr. Friede noted there are more drugs vying to be tested than there are clinical sites. He said that it is “imperative” for the STAC-EE committee to prioritize which drugs to test. He added that safely collecting clinical data under biosafe conditions would be challenging and asks that investigators work together to develop critical measures that could be standardized across all testing sites.