Why Patients and Doctors Need to Get Involved in Clinical Trials
Prevention & Treatment Patients with inflammatory bowel disease (IBD) know there’s no cure for their illnesses. Still, there’s hope for new treatments, therapies and an eventual cure.
Those remedies start with clinical trials, or research studies looking into the effectiveness and safety of medical treatments and devices to treat a variety of conditions.
Need for new treatments
The Crohn’s and Colitis Foundation (CCF), a national resource for adults and children with Crohn’s disease and ulcerative colitis, is spearheading an effort to get patients and medical providers involved in clinical trials.
“The risk of not participating in a clinical trial is that there will be less information about potential cures and new treatment options for patients in the future,” says Courtney Bisbee, the manager of patient education for the Foundation. “There currently is no cure for Crohn’s disease and ulcerative colitis. The only way that new treatment options that can potentially cure these diseases are going to happen is through clinical trials, where the FDA can review data and approve the new treatment is safe and effective for patients.”
Right now, IBD doctors looking to enroll their patients in clinical trials need to search for a trial on clinicaltrials.gov. But the site is cumbersome, especially since it’s used for all the clinical trials in the U.S., not just IBD studies.
“We need patient participation to show if new treatments are effective and safe for patients.”
That’s why CCF has secured funding to create its own clinical trials database, specifically for patients with IBD. The clinical trials’ matching service will take a patient profile, pull data from clinical trials.gov and then create a customized list of trials the patient might be eligible for based on their disease type, their location and their treatment history, among other factors.
“The majority of patients I’ve talked with have said they’ve entered a trial because they felt they could individually benefit from it, in addition to wanting to contribute to IBD research to help other patients like them in the future,” says Bisbee, who is developing and managing CCF’s database, named “Clinical Trial Community,” which will be launched in 2018.
In the meantime, the Foundation has provided patients and providers with a customized IBD Clinical Trial Finder tool to search for local trials in their area.
Despite the availability of clinical trials, not all patients and providers are aware of the studies.
“If the patient is unaware of a clinical trial as a potential treatment option and doesn’t understand what their participation in a clinical trial may look like, they are less likely to enroll in a trial, therefore making it difficult for researchers to advance new treatment options,” says Bisbee, who encourages gastroenterologists to talk to their patients about clinical trials as one of the many treatment options available to them. “We need patient participation to show if any of these treatments are ultimately safe and effective.”
Even if patients know about clinical trials, they don’t always sign up. CCF conducted focus groups of IBD patients in Idaho, Miami and Connecticut to get an idea of what patients think about clinical trials. The results? The majority didn’t know much about trials.
Patients were worried about feeling like a guinea pig, and they feared getting a placebo instead of the actual drug. They were concerned their disease would worsen if they took the placebo.
Other worries included wondering if insurance would cover the medication and feeling concerned about paying transportation fees and childcare costs while traveling to the clinical trials. Actually, pharmaceutical and biotech companies often cover the cost of the trials. In some studies, if patients receiving a placebo find their disease getting worse, protocol can help the patient receive the drug later.
The Foundation’s Clinical Trials Community was developed in order to address these patient concerns and to help increase awareness of trials and educate patients about participation. The program launched in July 2017 with resources for adult patients and professionals (patient, research coordinator, and investigator testimonial videos, educational infographics, research updates blog, IBD Clinical Trial Finder). The program will expand in 2018 to include the creation of additional adult patient resources as well as a full build out of pediatric clinical trial resources in collaboration with ImproveCareNow and NASPGHAN.