CDISC Releases Therapeutic Area User Guide to Accelerate Development of Safer, More Effective Vaccines

05-Oct-2017 Intellasia | BusinessWire | 2:18 AM Print This Post

AUSTIN, Texas–(BUSINESS WIRE)–The Clinical Data Interchange Standards Consortium (CDISC) is pleased to
announce the release of a new Therapeutic Area Standard for Vaccines in
the form of a User Guide for data managers, statisticians, programmers
and study managers, which is freely available on the CDISC
. This Vaccines standard was developed and funded through BioVacSafe,
Biomarkers for Enhanced Vaccines Safety, a project funded by the
Innovative Medicines Initiative (IMI).

Since their discovery, vaccines have protected millions of people
worldwide from a broad range of infectious diseases, making them one of
the most effective public health interventions available. New and better
vaccines are still urgently needed, yet their introduction is hampered
by lengthy and expensive vaccine safety testing procedures. The goal of
BioVacSafe is to develop cutting-edge tools to speed up and improve the
testing and monitoring of vaccine safety, both before and after release
to the market. By bringing together for the first time three of
Europe’s leading vaccine and manufacture companies as well as top
experts from academic institutions and small and medium-sized
enterprises (SMEs), the standard will ultimately accelerate the
development and introduction of a new generation of safer, more
effective vaccines.

“We are delighted to see this important new vaccines data standard
published and are grateful to IMI for their generous support in
achieving this goal,” remarked Stephen Pyke, Senior Vice President, GSK.
“This will help to simplify and streamline the long journey for all new
vaccines from idea to clinical use.”

CDISC Standards were originally developed to enhance the review of
safety and efficacy data, and most recently have been extended in
specific disease areas. The Therapeutic Area User Guide describes the
most common biomedical concepts relevant to Vaccine studies, and the
necessary metadata to represent such data consistently with CDISC

This CDISC Therapeutic Area Standard for Vaccines 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 additional stakeholders. The goal of
the CFAST initiative is 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 30 disease


CDISC is a 501(c)(3) global, non-profit organization that develops data
standards to foster smarter research and enable connections to
healthcare. CDISC standards allow data to speak the same
, by providing common formats for data collection, data
sharing and data analyses to make the most of the valuable information
offered by patients participating in research studies around the globe,
enabling researchers to discover new treatments, find breakthroughs, and
unlock cures. CDISC standards are required for regulatory submissions to
the U.S. FDA and Japan PMDA, are endorsed by the China CFDA, and are
requested for use by the European Innovative Medicines Initiative (IMI).
The suite of CDISC standards is freely available on the CDISC

CDISC is funded through the generous support of over 400 member
organizations from pharmaceutical, biotech, clinical research
organizations, regulatory agencies, academia, and healthcare, as well as
through grants, authorized CDISC Education courses, events and
charitable contributions. To find out more about how to support CDISC
and get involved, please visit


Ann P. White, +1-512-363-5826
[email protected]


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