AUSTIN, Texas--(BUSINESS WIRE)--CDISC is pleased to announce the release of a Therapeutic Area (TA) Standard that specifies how to structure data in clinical research studies for Colorectal Cancer. The standard, released in the form of User Guide for data managers, statisticians, programmers and study managers, is freely available on the CDISC website. CDISC Therapeutic Area User Guides (TAUG) provide examples and guidance on implementing CDISC standards to drive operational efficiencies within the organizations that use them, expedite the regulatory review process and reduce time to market.
Colorectal cancer is the second most commonly occurring cancer in women and third most commonly occurring cancer in men, according to the World Cancer Research Fund International. There were over 1.8 million new cases in 2018. CDISC Standards enable global researchers to efficiently aggregate and analyze data across studies so they can find the hidden connections that make a difference in the lives of the patients.
"Clinical trial designs and their execution in oncology, especially in large indications such as colorectal cancer, become increasingly complex and expensive,” said Dr. Barbara Leutgeb, Medical Director, Product Development - Oncology at Roche. “The development of CDISC Standards is a true collaborative effort. Working together with stakeholders from health authorities to colleagues from the pharmaceutical industry was a great experience. We trust that the Therapeutic Area User Guide for Colorectal Cancer will help to plan clinical trials, speed up their execution, and compare their results better, all to the benefit of patients with this disease."
“CDISC is deeply grateful to our volunteers, members, and the U.S. Food and Drug Administration for their hard work and financial support that brought this standard to fruition,” said David R. Bobbitt, President and CEO. “We hope researchers will use this standard to amplify the value of their data.”
This CDISC Therapeutic Area standard for Colorectal Cancer 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. Funding for this standard was made possible, in part, by the US FDA through grant 1U24FD005634-01.
CDISC standards have been adopted and used in more than 90 countries. To date, TA standards have been developed for over 30 disease areas.
CDISC creates clarity in clinical research by convening a global community to develop and advance data standards of the highest quality. Required by the United States Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and adopted by the world’s leading research organizations, CDISC standards enable the accessibility, interoperability, and reusability of data. With the help of CDISC standards, the entire research community can maximize the value of data for more efficient and meaningful research that has invaluable impact on global health. CDISC is a 501(c)(3) global nonprofit charitable organization and is headquartered in Austin, Texas, with hundreds of employees, volunteers, and member organizations around the world. www.cdisc.org.