A gastroenterologist explains how patients with active inflammatory bowel disease can get early access to newer, potentially better treatments — for free.
Hope is on the horizon for patients with inflammatory bowel disease (IBD), a chronic condition with no cure that requires a lifetime of treatment or surgery to keep in check.
Multiple clinical trials for a variety of leading-edge medicines are underway at the University of Michigan Inflammatory Bowel Disease Program — including six trials that involve drug therapies to target Crohn's disease and ulcerative colitis. Both conditions fall under the IBD umbrella.
The work might prompt IBD patients to ask themselves: Is a clinical trial right for me?
Eligibility and safety
For many, their expectation is that clinical trials are a last resort.
Most clinical trial referrals occur because patients have cycled through most or all existing treatment options and can no longer control their IBD, says gastroenterologist Peter Higgins, M.D., Ph.D., M.Sc., director of the IBD program at U-M.
"They are looking for new options," Higgins says. "A lot of times, they can skip ahead to new generations of medicines that aren't yet approved by the Food and Drug Administration or commercially available — but trials are showing they can be safer, more potent and have fewer side effects."
Because clinical trials test the safety and effectiveness of new medicines, patients undergo heightened monitoring. They receive more frequent checks of their vital signs and blood chemistry, and they receive endoscopies more often than traditional IBD patients.
Another benefit: Higgins notes that patients in clinical trials tend to do better overall, which researchers attribute to the heightened care and attention.
Clinical trials also can ease a patient's financial burden. Monitoring is free — and so is the medication.
"These medicines may run $4,000 to $8,000 a month," Higgins says. "If that drug is helping someone to stay in remission, then it's worth it. But it's extremely helpful to get it for free."
Participants also are reimbursed for their travel expenses and parking, he adds, noting that the cost of helping others is priceless.
Because IBD affects only about 1 million people in the United States, finding volunteers for clinical trials can be difficult.
But each one brings researchers a step closer to a cure. And for many patients, clinical trials represent a fast pass to next-generation treatments. Patients can get access to new, better treatments for IBD years before they make it to market. Recently approved IBD medications like Entyvio and Stelara were available to patients in clinical trials more than five years before they were available by prescription.
"A clinical trial is often a good choice for many people with active IBD," Higgins says. "We welcome all volunteers."
To participate in an IBD clinical trial, call (734) 615-4843 or email [email protected].
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