New Therapeutic Area User Guide for the Standardization of Medical Data in Pancreatic Cancer Now Available for Use by Research Community
LOS ANGELES, Calif. and AUSTIN, Texas (Nov. 4, 2021) – The Pancreatic Cancer Action Network (PanCAN) and CDISC have announced the release of a new Therapeutic Area User Guide setting the first-ever global data standards specifically for pancreatic cancer. The project was funded through a two-year grant awarded to CDISC by PanCAN and is designed to lead to greater efficiencies and data sharing among the pancreatic cancer scientific community.
The User Guide includes global, nonproprietary clinical metadata standards and core precision medicine-focused concepts designed for pancreatic cancer to enable global researchers to efficiently collect, organize and analyze data across studies, facilitating the development of treatments that make a difference in the lives of pancreatic cancer patients. It is intended to drive operational efficiencies, expedite the regulatory review process, enable data sharing and reduce the time it takes to bring safe and effective treatments to market.
“Through this partnership with CDISC to standardize data submissions to regulatory agencies, we are creating opportunities to streamline drug development in the pancreatic cancer space,” said Sudheer Doss, PhD, PanCAN’s Chief Business Officer. “With a disease as difficult to treat as pancreatic cancer, patients can’t afford to wait. By accelerating clinical advancements through these efficiencies, we hope to improve patient outcomes and, ultimately, increase survival.”
“We are grateful to PanCAN for partnering with CDISC to allow the development of these crucial standards,” said Rhonda Facile, VP, Partnerships and Development, CDISC. “It is our hope that the research community will swiftly adopt this Therapeutic Area User Guide to conduct more powerful and meaningful research to enable the development of treatments and therapies to treat this devastating disease.”
Two years in the making, the User Guide for pancreatic cancer is now freely available via the CDISC website. To date, CDISC has developed Therapeutic Area User Guides for over 40 disease areas.
Pancreatic cancer is currently the third leading cause of cancer-related death in the U.S., with an overall five-year survival rate of just 10 percent. In 2021 more than 60,000 Americans will be diagnosed with pancreatic cancer and approximately 48,000 will die from the disease, underscoring the scientific collaboration to develop new and better treatment options for patients.
To learn more about pancreatic cancer, please visit pancan.org.
About the Pancreatic Cancer Action Network
The Pancreatic Cancer Action Network (PanCAN) leads the way in accelerating critical progress for pancreatic cancer patients. PanCAN takes bold action by funding life-saving research, providing personalized patient services and creating a community of supporters and volunteers who will stop at nothing to create a world in which all pancreatic cancer patients will thrive.
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), recommended by the China National Medical Products Administration (NMPA) 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 with administrative offices in Austin, Texas, with hundreds of employees, volunteers, and member organizations around the world. https://www.cdisc.org/