Regulatory Focus™ > News Articles > New Clinical Data Standards Intended to Accelerate Development of Alzheimer's, Asthma Treatments

New Clinical Data Standards Intended to Accelerate Development of Alzheimer's, Asthma Treatments

Posted 04 February 2014 | By

A clinical data standards initiative supported by the US Food and Drug Administration (FDA) is announcing the launch of two new standards intended to expedite the development of treatments for asthma and Alzheimer's disease.


The initiative, known as the Coalition for Accelerating Standards and Therapies (CFAST), was 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 at the time of CFAST's launch that the partnership 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 Standards

For its part, FDA has been investing heavily in the partnership. In 2013 it granted CFAST $2 million to launch and maintain therapeutic area standards and development projects, and approved the launch of a new disease simulation tool developed by CFAST partner C-Path and intended to improve clinical trial design for investigating Alzheimer's treatments.

"This new tool will make it possible to simulate clinical trials by integrating all relevant data so future studies will be more efficient and more likely to be successful," C-Path wrote at the time.

Now those investments are starting to pay off.

On 28 January 2014, CFAST announced that it had launched two new Therapeutic Area Standards developed by CDISC, C-Path and an industry-led initiative known as TransCelerate BioPharma Inc. (TransCelerate).

The two standards, the Asthma Therapeutic Area (TA) User Guide (UG) (Version 1.0) and the Alzheimer's TAUG (Version 2.0), were lauded as being the "first time that TA standards have been fully developed through the CFAST partnership using the enhanced CDISC standards development process."

"These user guides … are expected to further accelerate the development of additional TA standards," the group said in a statement. "This is expected to streamline the process of developing new therapies for patients."

The TAUG's are geared toward providing companies with guidance on how to implement Study Data Tabulation Models (SDTM) in their regulatory submissions to FDA. "This User Guide describes the most common research concepts relevant to studies of Alzheimer's disease and mild cognitive impairment, and gives guidance on the necessary metadata to represent in a way that is consistent with CDISC standards," CFAST wrote of the Alzheimer's document.

Further standards are presently in development for diseases (multiple sclerosis, diabetes, traumatic brain injury, hepatitis C, breast cancer, schizophrenia, influenza, and COPD) and cross-functional areas like cardiovascular endpoints and QT studies.


CFAST Statement

Asthma Therapeutic Area (TA) User Guide (UG) (Version 1.0)

Alzheimer's TAUG (Version 2.0)

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