Regulatory Focus™ > News Articles > FDA Funding Set to Develop New Clinical Data Standards for Diabetes, Hepatitis C Drugs

FDA Funding Set to Develop New Clinical Data Standards for Diabetes, Hepatitis C Drugs

Posted 26 August 2013 | By Alexander Gaffney, RAC

US regulators are looking to infuse a relatively new regulatory data harmonization group with some major funding to help support several regulatory initiatives, including therapeutic area data standards for diabetes, lipid lowering, and hepatitis C drugs.


The group in question is the Coalition for Accelerating Standards and Therapies (CFAST), a group launched in October 2012 with the support of the US Food and Drug Administration (FDA), the Clinical Data Interchange Standards Consortium (CDISC) and the Critical Path Institute (C-Path).

FDA, CDISC and C-Path all explained in a statement that the partnership between their groups is intended to work toward the development of new standardized approaches to meeting needs identified by regulators by employing 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," C-Path President Carolyn Compton said in a statement in 2012. "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 another statement, Janet Woodcock, director of FDA's Center for Drug Evaluation and Research (CDER), likened the stream of clinical data coming into the agency to firefighting 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 firefighting 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.

New Funding, New Projects on the Horizon

The group has already released some tools intended to help combine and report data from multiple studies for tuberculosis drugs, but in a new Federal Register statement, FDA makes clear that it has far more it wants CFAST to accomplish.

At present, FDA said, "The lack of standardized data affects CDER's review processes by curtailing a reviewer's ability to perform integral tasks such as rapid acquisition, analysis, storage, and reporting of regulatory data."

"Improved data quality, accessibility, and predictability will give reviewers more time to carry out complex analyses, ask in-depth questions, and address late-emerging issues," FDA continued. "Standardized data will allow reviewers to increase review consistency and perform evaluations across the drug lifecycle. This will enhance the Center's performance across key drug regulatory functions and ongoing business operations, including premarket review, post-market safety, oversight of drug quality, and oversight of drug promotion."

In other words, by helping CFAST, FDA can help both itself and industry by expediting review times and provide a more stable and reliable review platform.

To help CFAST, FDA said it will be giving a $2 million grant to C-Path to accomplish five tasks with respect to CFAST:

  • maintain its current infrastructure
  • coordinate and manage its therapeutic area standards development projects
  • identify and engage with experts in various therapeutic areas
  • develop new therapeutic areas data standards for diabetes, QT studies, lipid lowering/altering drugs, and hepatitis C, as well as additional areas as warranted
  • identify and implement continuous quality improvements to the data standards development process and its end products.

The project is slated to continue over the course of three years, with an anticipated start date of 15 September 2013.

Federal Register Notice

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