Chimerix has already taken the drug candidate to Phase 3 clinical trials targeting a different virus, adenovirus. That means Chimerix already has plenty of data about the drug’s safety in patients.
But the progress toward an Ebola treatment trials raises the question of how to test these drugs in patients. Randomized controlled clinical trials are the gold standard by which drugs are tested for efficacy. But drugs for deadly diseases, such as Ebola, are not always tested in this manner. Some ethicists say denying a test group of patients even an experimental drug for such a deadly disease would be wrong. Michelle Berrey, Chimerix’s CEO, suggests an alternative approach where all test groups receive drugs in a comparative trial. If the mortality rate improves in one group receiving a particular drug, patients could be shifted to that group.
“You minimize the number of individuals who are exposed to a less than efficacious agent,” Berrey says. “So there are some ways to conduct these trials without having necessarily a placebo control.”
These so-called adaptive clinical trials aren’t unique to Ebola drug testing. But pharma companies and CROs have been pursuing more of these kinds of trials, saying that the ability to make changes and adjust as safety and efficacy data become available, speeds up the clinical testing process.
GlaxoSmithKline (NYSE: [[ticker:GSK]]), which earlier this year started Phase 1 trials of its Ebola vaccine candidate in partnership with the National Institutes of Health, is already looking ahead toward Phase 3 trials. Donna Altenpohl, vice president of U.S. policy for GSK, says the pharma company is talking with the Food and Drug Administration, the European Medicines Agency, and the Bill and Melinda Gates Foundation about clinical trial models that would keep patients safe while also testing for efficacy. She says these approaches could be applied to trials of other drugs in other diseases.
“We don’t want it to always be a just in time situation, we want it to be sustainable,” Altenpohl says. “When you have a more sustainable platform and a more predictable platform, it encourages people to invest in medical countermeasures.”
