As conventional wisdom dictates, in order to solve a problem, one must first define it. Low enrollment in cancer drug trials has been a problem for developers, but a new study shows just how dire the situation really is. Less than 1% of cancer patients in one survey enrolled in a clinical trial, according to the study.
Beyond the pathetic numbers are a host of other alarming issues. Most patients in the trials tend to be white and young, prompting questions about how useful the data are in representing the benefits of a drug for a more diverse population, Reuters reported.
"Are you going to see the same benefits in the average patient?" Dr. Monika Krzyzanowska, a cancer researcher at Princess Margaret Hospital in Toronto, Canada, who didn't participate in the study, said in an interview with Reuters. "Are the risks in the clinical trial truly reflective of the risk in the general population if the enrolled patients are younger and healthier?"
Showing just how abysmal cancer trials enrollment has become, researchers mined a cancer registry in California and found that only 1,566 of 244,528--or about .6%--of patients with solid tumors had taken part in trials. In addition to the disproportionate number of white patients under the age of 65, there were also very few patients with early-stage tumors.
To be fair, the low-participation problem is a tough nut to crack. Experimental drugs can be risky, and developers often seek very specific types of patients for their trials to give them the best chances of success. Furthermore, companies often have to seek patients for cancer trials in multiple countries, especially for larger studies needed to get FDA approval.
- check out the Reuters story
- here's the abstract from the Annals of Surgery