The Critical Path Institute (C-Path) and the Clinical Data Interchange Standards Consortium (CDISC), two non-profit organisations established in the US to address process gaps in medical research and drug development, have announced a formal partnership to set new clinical data standards aimed at facilitating development of new therapies for major diseases.
Based in Austin, Texas, CDISC has opened an office adjacent to C-Path’s headquarters in Tucson, Arizona to optimise the collaborative effort, which will focus on brain diseases such as multiple sclerosis, amyotrophic lateral sclerosis and Huntingdon’s disease, as well as lung cancer, diabetes mellitus and other conditions identified by the US Food and Drug Administration (FDA) as high-priority public health challenges.
The two organisations have already worked together on an Alzheimer’s disease clinical database, launched by C-Path’s Coalition Against Major Diseases (CAMD) in June 2010. In that initiative, CAMD used CDISC data standards to combine patient data from eleven clinical trials that were openly shared by seven pharmaceutical companies.
The Alzheimer’s disease database includes more than 4,000 patients and is now available to qualified researchers around the world, providing a standardised platform for the design of more efficient clinical trials to test new therapies much earlier in the disease cycle.
According to Dr Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, the lack of clinical data standards and accurate databases that “truly describe the progression” of diseases is a major obstacle to rapid advances in the development of new therapies.
C-Path and CDISC “are two of FDA’s most successful partners, and their joint effort to expand the scope of CAMD will make even greater strides possible”, she commented.
Data standards and better databases will also enable the FDA to review new applications more efficiently, C-Path and CDISC noted. The agency’s draft document, CDER Data Standards Plan Version 1.0, outlines a proposed comprehensive data standards programme to be implemented within FDA.
“With an increasing volume of submissions,” the draft plan states, “CDER and the Center for Biologics Evaluation and Research (CBER) must transition to standardised electronic regulatory submissions in order to meet strict regulatory deadlines.”