The classic approach to drug development dictates a linear progression from animal research to humans. But with the number of cancer therapies in clinical trials up a whopping 70 percent in just three years, researchers have begun to mix the two stages in an effort to streamline their work and advance new drugs on a faster timeline.
Working with a $4.2 million grant from the National Cancer Institute, collaborators at Dana-Farber/Harvard Cancer Center test drugs simultaneously on genetically engineered mice and humans. The theory is that the mice can help identify subpopulations which are more likely to respond to a new therapy. Adopting a more flexible approach to the trials will give researchers a chance to adjust their targeted populations, increasing the likelihood of success. And the research can shed new light on the way combinational therapies--a popular approach in the cancer field-can work in the clinic.
"The real goal of our effort is to understand why one patient responded and why the other didn't, so that then the next round of trials, we give the drug only to that patient who will respond,'' said Pier Paulo Pandolfi, director of the cancer genetics program at Beth Israel Deaconess.
With more and more drugs in the clinic, researchers don't always have all the patients they need to test their theories.
"I would say there's a bunch of people around the country who are all sitting back and saying, 'The model is kind of broken,''' said Dr. Derek Raghavan. "We don't have enough patients going into clinical trials; we have to be smarter about how to work up the first stages of clinical research.''
- here's the story from the Boston Globe