Crohn’s & Colitis Foundation Launches New IBD Clinical Trials Community

Goal of community is to educate patients and providers about clinical trials, helping to accelerate drug development process

NEW YORK, NY – Clinical trials are essential for the evaluation and approval of medication options for patients living with inflammatory bowel diseases (IBD). Despite their importance, only six percent of trials are completed on time due to unfulfilled enrollment among other issues. These delays create significant barriers to the drug approval process, and result in fewer available treatments for Crohn’s disease and ulcerative colitis patients. In observance of International Clinical Trials Day, the Crohn’s & Colitis Foundation announced that it is developing an IBD Clinical Trials Community with the goal of educating and supporting IBD patients interested in participating in clinical trials.  Ultimately, this effort should help to decrease the time it takes to get a drug through the drug development process, thereby accelerating the time to market and providing patients with a greater number of treatment options.

“If we want more medication options for IBD patients, we need to improve efficiencies in recruiting patients for clinical trials,” said Caren Heller, MD, the Foundation's Chief Scientific Officer. “Clinical trial recruitment is often a challenging step toward approval of new treatments for patients across all disease states. Our IBD Clinical Trials Community will change that by increasing awareness, education, and support for all clinical trials stakeholders.”

The Foundation's new IBD Clinical Trials Community will be comprised of gastroenterology professionals, patients, and researchers working together to increase clinical trial education and awareness and improve efficiencies and enrollment. It will significantly expand the work the Foundation is doing to increase awareness of clinical trials in IBD. The IBD Clinical Trial Community will be made up of local and national clinical trial awareness campaigns; print and electronic educational tools and resources for patients and providers; and a website to help patients find clinical trials suited to their needs and location. In addition, for those interested, it will include a peer-to-peer support program designed to connect someone interested in a clinical trial with an experienced clinical trial peer mentor.

The Foundation currently maintains a website that lists IBD clinical trials that are recruiting patients, and is searchable by geographic region and disease type. The Foundation's clinical trial registry can be found at www.crohnscolitisfoundation.org/clinicaltrials.

Patients also recognize the benefits that clinical trials can have on broadening treatment options and are eager to be informed of participation opportunities.

“I knew that my own uncontrolled Crohn's disease was guaranteed to cause me lots of trouble. Approved medications for treating IBD had failed me, so participation in a clinical trial was appealing to me,” said Carly Medosch, a Crohn’s disease patient and former clinical trial participant. “We are never going to be able to develop more effective treatments and eventually find a cure without patient participation in clinical trials. Even if the trials don't help you personally, the knowledge gained is tremendously important for the Crohn's and ulcerative colitis community as a whole.”

Another barrier to fulfilling trial enrollment is adequate communication between patients and providers. One study found that only a small portion of patients (20 percent) actually receive information about clinical research from their specialty care providers. 

“One hundred percent of IBD patients and their physicians want new, more effective therapies for IBD, but less than one percent of patients participate in clinical trials, and less than 10 percent of gastroenterologists refer their patients to centers for IBD clinical trials,” said Dr. Peter Higgins, director of the IBD Program at the University of Michigan and co-chairman of the Foundation's Clinical Research Alliance. “There are a lot of myths and misconceptions around clinical trials that need to be addressed before the field of IBD can move forward.”

The Foundation received initial funding for its IBD Clinical Trials Community earlier this year through educational grants from Celgene Corporation, Genentech, and Takeda Pharmaceuticals U.S.A., Inc. Additional support is provided by the Foundation's annual giving donors.

“In order to bring new therapies to market, treatments will have to be evaluated in clinical trials by the companies developing them,” said Michael Osso, the Foundation's President & CEO. “We must do all we can to ensure that patients are empowered to make educated decisions about all aspects of their care, including supporting their enrollment in clinical trials. That is why more in-depth education about clinical trials is so crucial.”

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Crohn's & Colitis Foundation

The Crohn's & Colitis Foundation is a non-profit, volunteer-fueled organization dedicated to finding the cures for Crohn's disease and ulcerative colitis, and to improving the quality of life of children and adults affected by these diseases. It was founded in 1967 by Irwin M. and Suzanne Rosenthal, William D. and Shelby Modell, and Henry D. Janowitz, M.D.