Magazine Article | November 1, 2015

Compassionate Use Trials Complex, But Improving

Source: Life Science Leader

By Gail Dutton, Contributing Editor
Follow Me On Twitter @GailLdutton

Expanded access (compassionate use) clinical trials aren’t as straightforward as they seem, and applications to expand access for cannabinoid drug trials are even more complicated. “Although the application process outlined on the FDA website seems very clear, the reality, unfortunately, is not like that,” according to Ricardo Alvarez, M.D., director of cancer research at Cancer Treatment Centers of America’s Southeastern Regional Medical Center in Atlanta and clinical assistant professor at Georgia Regents University. “I typically see eight- to 10-page applications,” Alvarez says, “but they take too much time. They’re the equivalent of filling out the paperwork for CDER (Center for Drug Evaluation and Research) trials involving two companies. That requires a lot of staff support.”