Industry/Government Alliance Needed for Clinical Trials

CRYSTAL CITY, Virginia—Industry and government need to form a new alliance to more efficiently conduct clinical trials, Howard Hochster, MD, professor of medicine, New York University Medical Center, said at the 2006 Gastrointestinal Oncology Conference, sponsored by the International Society of Gastrointestinal Oncology. "I think our [clinical trials] system is ailing. We need to reduce regulatory barriers, increase patient awareness, and increase physician participation, especially outside of academic medical centers," he said.

Testing Combination Regimens

One symptom of the ailing system: low trial enrollment in government-sponsored trials vs more robust enrollment in industry-sponsored trials. Dr. Hochster pointed to one government-funded trial, CALGB/SWOG 80405, as an example. The study, which is testing various combinations of chemotherapy (FOLFOX, FOLFIRI) plus targeted agents—cetuximab (Erbitux), bevacizumab (Avastin)—as first-line therapy for advanced colorectal cancer, needs 2,300 patients but has only recruited 250.

"This is not good," Dr. Hochster said. "This is a great trial from a scientific and academic point of view, but it's just not getting the patients."

Like CALGB/SWOG 80405, most National Institutes of Health (NIH)-sponsored clinical trials for colorectal cancer are designed to optimize drug combinations, while industry-funded trials focus on winning approval of a new drug, Dr. Hochster said.

He called industry's approach a "pile-on" tactic. "Industry just takes the standard of care and adds a new drug on top and improves things a little bit," he said. "You end up with a much more expensive regimen, but you never go back and optimize and compare to see if you can substitute the new drug for another drug somewhere. That kind of a trial is a non-winning design from the drug company's point of view."

Why Enrollment Is Slow

Dr. Hochster outlined several factors that contribute to slow enrollment in government trials. Patients are more interested in trials that test investigational new drugs, he said, than in trials testing various combinations and schedules of drugs already on the market. "We need to educate patients and simplify the clinical trials enrollment procedures," he said. "The informed consent process is daunting."

And physicians tend to gravitate toward industry-sponsored trials because they pay better, Dr. Hochster said. "In the [National Cancer Institute-sponsored] intergroup trials, you get $2,000 per patient, which is a really poor amount. You're going to be lucky to break even on that. And you can't expect people in practice to do clinical trials just because they're altruistic. Most of the trials being done by NCI end up costing practitioners money. That's not a good system."

Most physicians outside of academic medical centers cannot even participate in NCI trials, Dr. Hochster said. Several years ago NCI launched an initiative, the Clinical Trials Support Unit (CTSU), to bring more trials to community physicians, but CTSU is no longer taking new physicians. "You can't even enroll in CTSU anymore," he said.

Billing vagaries are other barriers for physicians wishing to enroll patients in trials, according to Dr. Hochster. "Our nurses spend a lot of time tracking procedures and trying to figure out what qualifies as standard of care and what qualifies as research. They become accounting gnomes for our billing office," he said.

He added that streamlining adverse event reporting would also help encourage physicians interested in enrolling patients in trials. "Right now the paperwork burden is just enormous," he said.

More Rational Trials

Dr. Hochster said that "a new alliance" between industry and government could streamline improvements in care. Ideally, drug companies would contribute to an NCI research fund that would dole out money for "more rational trials, instead of trials that are simply designed to get a new drug approved."