Despite state's prominence in drug testing, few who could benefit from early access to therapy know it exists.
Minnesotans suffering from arthritis, cancer, diabetes, epilepsy and other diseases have access to many new, potentially lifesaving medicines years before they are commercially available. Yet, most don't know it.
Most also don't know that 11 percent of all clinical trials in the United States take place in Minnesota.
Thanks to more than 2,400 clinical trials of new medicines conducted in the state since 1999, including 391 trials still recruiting patients, Minnesota is an under-the-radar center for drug research, according to a report released Friday by the Pharmaceutical Research and Manufacturers of America. But these trials also often struggle to attract the participants needed to win government approval.
A coalition formed a year ago -- the Minnesota Clinical Research Alliance -- is trying to change that.
Getting more Minnesotans to take advantage of such trials could not only help their health, it could help get lifesaving medicines into the public's hands sooner, said Jeff Trewhitt, senior director of communications and public affairs for PhRMA.
"More than 70 percent of all clinical trials have patient enrollment problems," Trewhitt said in an interview Friday. "Most people just don't know about them."
For instance, fewer than 5 percent of cancer patients participate in trials that could not only help bring new medicines to market but prolong their lives, he said.
"This is a problem nationwide," he said.
It can take 10 to 15 years for a new drug to wind its way through the approval process by the U.S. Food and Drug Administration, Trewhitt said. Clinical testing for the drug's safety and effectiveness on humans can take up to seven years of that time.
Joy Frestedt has been involved with clinical research for more than 30 years. The president and CEO of Frestedt Inc. said researchers are drawn to Minnesota's well-known medical centers and research institutions.
"There is a solid biomedical research infrastructure in this state. We do clinical trials well. We're respected nationally," she said.
Still, Trewhitt and Frestedt acknowledged that adding to the challenge of attracting more patients to trials is overcoming the fear and stigma of participating in "experimental" treatment. These drugs, after all, have not yet won FDA approval. Trewhitt said, on average, only one of five drugs tested clears clinical trials.
"There is risk involved," he said.
But Frestedt that even drugs that do not ultimately win FDA approval still may benefit the patients who take them.
Being a center for trials also has economic benefits, Trewhitt said. It has an economic impact for the state. Consider: It costs an estimated $1.2 billion to develop a single biotechnology drug. Testing that drug on humans accounts for 45 percent to 75 percent of that cost -- meaning that for trials in Minnesota, that is money spent in Minnesota.
Since 1999, researchers have conducted 112 drug trials in Duluth, 44 in St. Cloud, 707 in Rochester and 212 in St. Paul. Minneapolis has been drug trial central for the state, home to about 1,500 trials since 1999.
James Walsh • 612-673-7428