Regulatory Focus™ > News Articles > New Regulatory Data Standards Partnership Formed to Accelerate Research

New Regulatory Data Standards Partnership Formed to Accelerate Research

Posted 25 June 2012 | By Alexander Gaffney, RAC 

A new partnership between two regulatory organizations supported by the US Food and Drug Administration (FDA) has the potential to accelerate clinical research and medical product development, the groups said in a statement.

In a 21 June statement, the Clinical Data Interchange Standards Consortium (CDISC) and the Critical path Institute (C-Path), announced the formation of a partnership with FDA to develop new data standards, tools and methods to guide the development of new therapies in areas "important to public health."

The new partnership will be called the Coalition for Accelerating Standards and Therapies (CFAST), and will utilize FDA's prioritized list of therapeutic area needs to guide development of standardized data approaches.

"We need a means to scale the process and manage the development of a very large number of therapeutic area standards" said Dr Carolyn Compton, president and CEO of C-Path in a statement. "The establishment of CFAST embodies our resolve to take what we have learned from the initial projects to formulate a new process that will be significantly more efficient while retaining the rigor that is essential to this work."

In a statement on its website, FDA said it "encourage[s] stakeholders to engage in and, where possible, support [CDISC and C-Path's] data standardization efforts."

The organizations said in a statement they are currently developing standards for Tuberculosis, Pain, Parkinson's Disease, Polycystic Kidney Disease, Virology, Oncology, and Cardiovascular Disease.


Read more:

CDISC, C-Path and FDA Collaborate to Develop Data Standards to Streamline Path to New Therapies


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