FDA presents novel plan for testing and fast-tracking Ebola drugs
- The FDA is implementing an umbrella study design in which experimental Ebola drugs will be tested against a comparison drug. The goal is to expedite development of an effective treatment, while still testing for any potential seriously harmful adverse events.
- There are currently 10 Ebola vaccines in development, including two which are slated to enter mid- to late-stage testing by December or January.
- The FDA's new approach to testing Ebola drugs was announced at the American Society of Tropical Medicine and Hygiene in Louisiana. While there were thousands of scientists in attendance, at least 30 scientists were barred from attending because they had recently been working in West Africa.
With a situation like the Ebola crisis, which has led to a fair amount of panic and hysteria, there is a sense that any experimental therapy should be considered. However, the FDA maintains that a basic "benefits vs. risks" approach to testing should be used as part of a novel design to testing Ebola drugs.
The goal of testing numerous drugs at the same time against comparators, while providing supportive care to patients, is to expedite discovery of an effective drug while still offering some level of protection against potentially dangerous therapies.
- Associated Press US officials unveil plan to test Ebola drugs