Regulatory Focus™ > News Articles > Groups, FDA Announce Launch of New Clinical Data Standards Harmonization Partnership

Groups, FDA Announce Launch of New Clinical Data Standards Harmonization Partnership

Posted 24 October 2012 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA), the Clinical Data Interchange Standards Consortium (CDISC) and the Critical Path Institute (C-Path) have announced the formal launch of a new clinical data standards consortium known as the Coalition for Accelerating Standards and Therapies (C-FAST).

Both CDISC and C-Path are data organizations which set many of the global standards used to report data from clinical trials.

The partnership between all three organizations was first announced in June by the CDISC. As reported at the time by Regulatory Focus, the partnership is intended to work toward the development of new standardized approaches to meet prioritized needs identified by regulators.

In a statement, C-Path's president, Carolyn Compton, said the partnership was going to place a particular emphasis on the economies of scale.

"We need a means to scale the process and manage the development of a very large number of therapeutic area standards," Compton said. "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."

Among the disease areas being worked on are tuberculosis, pain management, Parkinson's disease, polycystic kidney disease, virology, oncology and cardiovascular disease.

In a statement released 24 October on FDA's website, Janet Woodcock, director of FDA's Center for Drug Evaluation and Research (CDER), likened the stream of clinical data coming into the agency to fire-fighting equipment.

"As part of the changing tide of drug regulation, we are seeing ever-increasing streams of data coming into the agency," explained Woodcock. "However, much like standardized fire-fighting equipment, we need to develop standardized definitions for individual diseases and the therapeutic approaches to treat them to be able to tap into this data stream."

Though CDISC has been instrumental in establishing common terminology for basic patient details such as age and gender, there exists a huge opportunity to establish similar standards for diseases and therapeutic areas, Woodcock argued.

"Establishing common standards for data reporting will provide new opportunities to transform the massive amount of data from drug studies on specific diseases into useful information to potentially speed the delivery of new therapies to patients," she said.

The partnership won praise from the president of one of the industry's most prominent clinical trials groups, the Association of Clinical Research Organizations (ACRO).

‎"I want to applaud CDISC and C-Path on the creation of CFAST. What we do not need is a lot of duplication," Douglas Peddicord, ACRO president, said. "Combining their strengths makes sense instead of having people do the same thing over and over. We need to have all of the stakeholders at the table and reduce the number of initiatives to let people do what they are good at."

Any standards developed by the group will be published as open standards, explained CDISC in a separate statement.

Woodcock said FDA believes the partnership will, "Provide an important resource for drug development and research that will result in enhancements in the evaluation of safe and innovative therapies for the public."

Previously, FDA has said that it, "encouraged stakeholders to engage in and, where possible, support CDISC and C-Path's data standardization efforts.


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