Consortium Brings Together FDA, Industry to Release New Data Reporting Standard

| 13 September 2012 | By Alexander Gaffney, RAC 

Officials with the Clinical Data Interchange Standards Consortium (CDISC) and the Critical Path Institute (C-Path), two organizations strongly affiliated with the US Food and Drug Administration (FDA), have announced the release of a new "breakthrough tool" used to help combine and report data from multiple studies.

The new tool is set to be used to standardize the way companies report data from research on drug regimens intended to treat tuberculosis (TB), a bacterial infection that primarily affects the lungs and kills more than a million people worldwide each year.

"For the first time, researchers are able to combine and evaluate data from multiple studies using a common approach," the group said in a statement. "This will help accelerate the development of new TB drugs by enhancing the design of clinical trials and the evaluation of new drugs."

The collected data can be used to support the regulatory review process by developing new clinical trial simulation models and evaluation methods, the group said.

"To support a regimen-based development approach, the research and regulatory communities need new standards and platforms to help conduct, submit, and review this work," said Mel Spigelman, president and CEO of the group TB Alliance "This new standard is an example of such a tool and will benefit both researchers and regulators, ultimately helping to ensure new TB cures reach those who need them as quickly as possible."

CDISC's project was the result of a collaboration known as the Critical Path to TB Drug Regimens Initiative, which brought together C-Path, CDISC, FDA and members of industry. The project is likely to be the last of the initiative, whose activities will be assumed under the banner of a new program known as the Coalition for Accelerating Standards and Therapies (CFAST). The CFAST program is set to work closely with FDA to address the needs of particular therapeutic areas to develop standardized data approaches, which in turn can make it easier for regulators to review products.