CDISC Announces New Standard for Major Depressive Disorder to Foster Development of New Treatments

The Clinical Data Interchange Standards Consortium (CDISC) has released the Major Depressive Disorder (MDD) Therapeutic Area User Guide v1.0.

According to the World Health Organization, an estimated 350 million people of all ages suffer from depression globally. Depression is the leading cause of disability worldwide, and is a major contributor to the overall global burden of disease.

"We congratulate the team on the release of the Major Depressive Disorder (MDD) Therapeutic Area User Guide. Including MDD, a record number of 10 Therapeutic Area User Guides were released in 2016," Brooke Hinkson, Head Global Clinical Data Standards at Merck and lead of the TransCelerate BioPharma Clinical Data Standards initiative said. "We would like to recognize the tremendous effort put forth by all CDISC standards development teams and thank them for their dedication throughout the year. We are making great strides in increasing the breadth of clinical data standards available to support research."

This CDISC Therapeutic Area standard was developed through the Coalition For Accelerating Standards and Therapies (CFAST) initiative, a partnership of CDISC and the Critical Path Institute (C-Path), with participation from the U.S. NIH National Cancer Institute Enterprise Vocabulary Services (NCI-EVS), the U.S. Food and Drug Administration (FDA), TransCelerate, the Japan Pharmaceutical and Medical Devices Agency (PMDA) and other stakeholders to accelerate clinical research and medical product development by creating and maintaining data standards, tools and methods for conducting research in therapeutic areas that are important to public health.

CDISC standards have been adopted and used in more than 90 countries, and are required for submissions to the U.S. FDA and Japan PMDA. To date, Therapeutic Area standards have been developed for over 25 disease areas.