While personalized medicine promises more individualized treatments, Janet Woodcock, director of the US Food and Drug Administration's Center for Drug Evaluation and Research, says that clinical trials have to change to be able to study such drugs that are effective only in small numbers of patients, reports the PharmExecBlog.
"We have to change the way we develop drugs," Woodcock said at a Personalized Medicine Coalition event earlier this month, according to the PharmExecBlog. She suggested turning "the clinical trial paradigm on its head" and setting up standing trials, similar to the I-Spy breast cancer trial at the National Institutes of Health.
Those trials, the PharmExecBlog says, could look at "patient responses to multiple issues raised by test therapies and biomarkers for certain diseases or conditions." This, Woodcock added, could lead to "breakthrough" therapies that be positioned for rapid approval.
Woodcock also noted that, to be effective in healthcare, personalized medicines not only have to work better than current treatments, but they also have to be more cost effective.