Clinical Trials Now Accessible to More Patients - guest blog by Heather Millar

It's 1:04 pm

Still no computer but in the meantime,I found this while surfing ,a blog written by Heather Millar about cancer patients being able to get into clinical trials much more quickly. The process is a slow one and it shouldn't be. Thanks to Dr. Stein,maybe this will start to change.


Written by Heather Millar.

For many cancer patients, maybe even the majority, clinical trials can seem completely out of reach. Unless you’re getting treatment in a big academic hospital, it can be hassle not only to find a clinical trial, but to get the “go ahead” to enroll in that trial. It can mean online research, forms, more tests, and travel to a research site. It can often take months to find a trial and get enrolled. And patients with disease that has spread—those for whom research most needs to be done—often don’t have that kind of energy or time.

But what if you could get in a clinical trial within just a couple of weeks – wherever you are in the country?

That’s the goal with a new research model being used by the Swiss pharmaceutical giant Novartis. The idea for a more patient-friendly approach came a couple years ago, when Novartis’ Steven Stein, MD, was talking with a fellow oncologist who practices in Florida. The friend was ranting about how difficult he found it to get his patients enrolled in clinical trials.

The conversation stuck with Stein, and he remembers thinking that there had to be a better way. The result, 2 years later, is the SIGNATURE trial, launched 10 months ago. Novartis is testing five potential drugs in this trial, and expects to increase that number to 10 by midsummer. About 100 patients all over the country have participated so far, and the company also expects those numbers to grow quickly.

Many companies, not just Novartis, are trying to figure out how to reach a broader range of patients. Patient recruitment has long been a bottleneck in medical research. Of the tens of thousands of trials being run in the United States each year, as many as 80 percent are delayed because scientists can’t find enough study subjects.

Many companies are experimenting with using social media to reach out to patients. For instance, the biotech giant Genentech recently announced a partnership with the patient information-sharing site Patients Like Me. Merck, and three other companies who prefer to remain anonymous, have partnered with the patient support group site Inspire.

Why? Because more data from more people is the only way their research will result in true “personalized medicine.” Expect to see more collaborations like this, and soon.

Drug companies are fairly secretive about new research models until they’re ready to announce them, so it’s impossible to know what other innovations may be in store. But Novartis may be the first company to try to bring the research “protocol” to patients directly wherever they are, and at the same time, to also target patients with specific genetic markers in their tumors.

Instead of requiring patients to travel to the study site, the Novartis trial brings the research to wherever the patients are, getting test results from approved local labs, then sending the experimental drugs to the place where the patient is being treated. Instead of focusing on cancers of a particular origin, the trial focuses on cancers of a specific set of particular genetic “signatures,” also called “mutations” or changes. These specific mutations have been found to drive the growth of many cancers, and Novartis has experimental drug agents that target them.

“We’re geography-agnostic, patients can call from anywhere,” Stein explains. “All you need is a potential genetic make-up, regardless of the kind of cancer you have.”

Interested? First you need to have your tumor genetically analyzed. (This is something that I think all cancer patients should do! That’s where the science is going, so ask your doctor about it.) You and your doctor can find more information at the SIGNATUREwebsite, where you can also find a number to call. If you qualify, Stein says, the time from first phone call to receiving the experimental drug is 2 weeks, sometimes 3.

SIGNATURE is one of dozens, even hundreds, of new research models being tried out by scientists around the world. You can find a good overview of what’s going on here. Experts say it’s likely that other companies will now follow Novartis’ lead, leading to a shift toward more patient-friendly processes in future research.

As we learn more and more about varied genetic profiles of cancer, researchers need more and more data. That data has to come from us, the patients, so get involved! You’ll probably help yourself, and who knows, you may also help the world.