CRYSTAL CITY, VirginiaIndustry 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 agentscetuximab (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."