A recent post on the FDA Voice blog entitled FDA Works with Partners to Establish Important Therapeutic Area Data Standards announced a new industry partnership called the Coalition For Accelerating Standards and Therapies (CFAST).

The new partnership brings together the FDA, the Clinical Data Interchange Standards Consortium (CDISC), and the Critical Path Institute (C-Path) with the goal of developing and maintaining data standards tailored to individual diseases and therapeutic areas.  The post reads:

In short, 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.

This partnership strengthens the 2011 initiative by the FDA’s Center for Drug Evaluation and Research (CDER) to identify a set of therapeutic areas that could benefit from further standardization, organizing them into three tiers of priority.  Several factors were considered for prioritization: (1) areas of particular medical need, (2) areas with existing data standardization projects underway, and (3) areas with greater drug development pipeline activity.

Overall, I believe these measures will be beneficial to the industry, allowing for better quality control and minimized project risk for specific diseases and therapeutic areas.  However, standards are only successful if they are widely used and embraced.

One potential challenge that may arise: a lot of standards work well for data reporting but may not apply for the actual collection of the data.  I posed this issue to my colleague Laura Jones (Clinical Data Manager) and she provided some great insight:

“It’s extremely important to have data standards for commonly collected clinical trial data.  Creating standards will benefit study closeout and analysis as well as lead to the faster development of clinical trials.  It will reduce the need to create independent data point names, generating more collaborative development between teams.  The globally defined data points can be shared across multiple studies for our clients and beyond.  Additionally, the standards will provide good quality data collection for analysis and study reports.”

It will be interesting to see how CFAST monitors and regulates the application of these new standards, both in the collection and reporting phases of data management.

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