RESEARCH TRIANGLE PARK, N.C. -- RTI Health Solutions has been awarded a project by the Critical Path Institute (C-Path) to create a standard, comprehensive symptom measure for use in irritable bowel syndrome (IBS) clinical trials.
"In the past, the efficacy of pharmaceutical treatments for IBS has been assessed using a variety of different measures with which the U.S. Food and Drug Administration (FDA) has expressed concerns," said Dr. Sheri Fehnel, vice president of Patient-Reported Outcomes (PRO) at RTI Health Solutions (RTI-HS) and the project director. "The development of the new instrument will involve input from a wide spectrum of IBS patients, clinical and measurement experts, and the FDA. The ultimate goal is to standardize evaluation and facilitate regulatory review of new drugs being developed to treat IBS," she added.
Currently, there are few effective treatments for IBS, a disease estimated to afflict approximately 60 million patients in the United States and Europe. There is a significant unmet need for new pharmaceuticals for IBS. The FDA has indicated there is also a need for a comprehensive and integrated PRO instrument to evaluate drugs in development for IBS.
In cooperation with the FDA and more than 20 pharmaceutical companies, C-Path formed the Patient-Reported Outcome (PRO) Consortium in 2008 to develop, evaluate and obtain FDA qualification of PRO instruments for use in clinical trials. Dr. Stephen Joel Coons, director of the PRO Consortium for C-Path, commented, "The development of an instrument for IBS is one of the first such projects the PRO Consortium has undertaken."
About Critical Path Institute (C-Path)
An independent, non-profit organization established in 2005, C-Path is committed to transformational improvement of the drug development process. An international leader in forming collaborations around this mission, C-Path has brought recognition to Arizona through first of its kind global programs and partnerships, which currently include over 750 scientists from government regulatory agencies, academia, patient advocacy organizations, and thirty major pharmaceutical companies. C-Path is headquartered in Tucson, Az., with offices in Phoenix, Az., and Rockville, Md. For more information, visit www.c-path.org.
About Patient-Reported Outcome (PRO) Consortium
The goal of the PRO Consortium is to develop qualified, publicly available PRO instruments for use in clinical trials where PRO endpoints are needed to more fully evaluate the safety and efficacy of new medical products. PRO instruments offer a means for capturing how a patient feels or functions with respect to her/his health or condition. Within the PRO Consortium, instruments are being developed to support label claims for efficacy in asthma, depression, functional dyspepsia, irritable bowel syndrome, mild cognitive impairment, lung cancer, and rheumatoid arthritis.
About RTI Health Solutions
Formed in 2000, RTI Health Solutions (www.rtihs.org) is a business unit of RTI International that focuses on research and services to the pharmaceutical, biotechnology and medical device industry. RTI Health Solutions has more than 210 employees in the United States and Europe, including experts in health economics, patient-reported outcomes, market access and outcomes strategy, health preference assessment, epidemiology, pharmacovigilance, biostatistics and clinical development.