MedPage Today: May 22, 2013
WASHINGTON — The FDA will need to “turn the clinical trial paradigm on its head” in order to allow more specifically targeted, personalized drug therapies to get on the market faster, a top agency official said Tuesday.
“We are going to have to change the way drugs are developed. Period,” said Janet Woodcock, MD, head of the FDA’s Center for Drug Evaluation and Research.
Answering every question needed from regulators about targeted therapies — such as who should receive the drug, at what dose, and with what expected side effects — won’t be possible in a traditional clinical trial, she explained at a luncheon hosted by the Personalized Medicine Coalition, a group of insurers, drugmakers and patient communities here whose goal is to “promote the understanding and adoption of personalized medicine concepts, services and products to benefit patients and the health system,” according to its website. Read more