U.S. Will Test Multiple Ebola Drugs in Clinical TrialsAnna Edney
U.S. health officials are planning a clinical trial that would involve multiple experimental Ebola drugs in an effort to speed approval of the medicines.
The National Institute of Allergy and Infectious Diseases and the Food and Drug Administration are working to complete a protocol and prioritize which treatments will be studied, said Edward Cox, director of the FDA’s Office of Antimicrobial Products. The trial will require some patients to forgo experimental drugs so researchers can see if the treatments are better than the standard of care, Cox said.
While the start of the trial hasn’t been scheduled, “things are moving forward very deliberately with a degree of urgency,” he said yesterday in a telephone interview.
The drugs chosen for the trial would be compared against standard supportive treatment, such as replacing fluids and using medicines to fight off other infections. If researchers choose to study three drugs, for example, three of four patients would get experimental medicines, while one of four would get supportive care, Cox said.
The study will start in the U.S. under the assumption there will be more Ebola patients here, he said. The research will involve doctors at NIAID and two hospitals where patients with the disease have been treated and cured -- Emory University Hospital in Atlanta and Nebraska Medical Center in Omaha, Cox said.
The trial eventually will expand to patients in West Africa where the Ebola outbreak is centered, Cox said. Typically, a company would conduct clinical trials on its own therapy, but this approach allows officials to shrink administrative duties and potentially speed drugs to patients.
“You can imagine a trial like this is not easy for a company to do independently,” said Luciana Borio, assistant commissioner for counterterrorism policy at the FDA.
Chimerix Inc., Mapp Biopharmaceutical Inc., Tekmira Pharmaceuticals Corp. and FujiFilm Holdings Corp. are among the companies developing medicines.
The NIAID trial won’t require a set number of participants, Cox said. Researchers who conduct the trial will check on effectiveness at several points and if a drug is found to work early, it would become standard care for those in the trial if supplies are available, he said.