NEW YORK, May 20, 2016 /PRNewswire-USNewswire/ -- 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 of America (CCFA) 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, CCFA'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."
CCFA'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 CCFA 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.
CCFA currently maintains a website that lists IBD clinical trials that are recruiting patients, and is searchable by geographic region and disease type. CCFA's clinical trial registry can be found at www.ccfa.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 CCFA'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."
CCFA 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 CCFA'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, CCFA'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."
About Crohn's Disease and Ulcerative Colitis Known collectively as inflammatory bowel diseases (IBD), Crohn's disease and ulcerative colitis affect 1 in 200 people in the United States. They are painful, medically incurable diseases that attack the digestive system. Crohn's disease may attack anywhere along the digestive tract, while ulcerative colitis inflames only the large intestine (colon). Symptoms may include abdominal pain, persistent diarrhea, rectal bleeding, fever, and weight loss. Many patients require numerous hospitalizations and surgery. Most people develop the diseases between the ages of 15 and 35; moreover, the incidence is increasing in children.
About the Crohn's & Colitis Foundation of AmericaThe Crohn's & Colitis Foundation of America (CCFA) is the largest non-profit, voluntary, health organization dedicated to finding cures for inflammatory bowel diseases (IBD). CCFA's mission is to cure Crohn's disease and ulcerative colitis, and to improve the quality of life of children and adults who suffer from these diseases. The Foundation works to fulfill its mission by funding research; providing educational resources for patients and their families, medical professionals, and the public; and furnishing supportive services for those afflicted with IBD. For more information visit www.ccfa.org, call 888-694-8872, or email [email protected].
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"If we want more medication options for IBD patients, we need to improve efficiencies in recruiting patients for clinical trials," said Caren Heller, MD, CCFA'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."
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CCFA'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 CCFA 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.
CCFA currently maintains a website that lists IBD clinical trials that are recruiting patients, and is searchable by geographic region and disease type. CCFA's clinical trial registry can be found at www.ccfa.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 CCFA'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."
CCFA 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 CCFA'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, CCFA'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."
About Crohn's Disease and Ulcerative Colitis Known collectively as inflammatory bowel diseases (IBD), Crohn's disease and ulcerative colitis affect 1 in 200 people in the United States. They are painful, medically incurable diseases that attack the digestive system. Crohn's disease may attack anywhere along the digestive tract, while ulcerative colitis inflames only the large intestine (colon). Symptoms may include abdominal pain, persistent diarrhea, rectal bleeding, fever, and weight loss. Many patients require numerous hospitalizations and surgery. Most people develop the diseases between the ages of 15 and 35; moreover, the incidence is increasing in children.
About the Crohn's & Colitis Foundation of AmericaThe Crohn's & Colitis Foundation of America (CCFA) is the largest non-profit, voluntary, health organization dedicated to finding cures for inflammatory bowel diseases (IBD). CCFA's mission is to cure Crohn's disease and ulcerative colitis, and to improve the quality of life of children and adults who suffer from these diseases. The Foundation works to fulfill its mission by funding research; providing educational resources for patients and their families, medical professionals, and the public; and furnishing supportive services for those afflicted with IBD. For more information visit www.ccfa.org, call 888-694-8872, or email [email protected].
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SOURCE Crohn's & Colitis Foundation of America
