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Pancreatic Cancer Action Network and CDISC Partner to Develop First Therapeutic Area Data Standards for Pancreatic Cancer

2019年08月27日 PM10:17
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MANHATTAN BEACH, Calif & AUSTIN, Texas

The Pancreatic Cancer Action Network (PanCAN), the leading pancreatic cancer patient advocacy organization, and CDISC, the global nonprofit dedicated to developing and advancing clinical research data standards of the highest quality, announced today a collaboration to establish the first-ever data standards specifically for pancreatic cancer.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190827005033/en/

Pancreatic cancer has the lowest survival rate among all major cancers. In nearly every country, pancreatic cancer is the only major cancer with a single-digit five-year survival rate. Every day, more than 1,250 people worldwide will be diagnosed with pancreatic cancer, and an estimated 1,180 will die from the disease. It is estimated that in 2020, 480,000 new cases will be diagnosed globally.

CDISC and PanCAN will develop global, nonproprietary clinical metadata standards that build upon existing CDISC standards to create a Therapeutic Area User Guide (TAUG), which describes how to use CDISC standards to represent data in research studies pertaining to specific diseases. CDISC TAUGs 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.

The TAUG is intended to facilitate increased ease of global health data sharing and will include core precision medicine-focused concepts in pancreatic cancer. The suite of CDISC standards – from planning and data collection to organization, analysis and reporting – capture how to structure commonly collected data and outcomes measurements in observational, academic and regulated clinical trials.

The project is being funded through a two-year grant awarded to CDISC by PanCAN.

“Standardizing clinical research data is especially critical with a disease like pancreatic cancer – time is of the essence for patients participating in clinical trials,” said PanCAN Chief Data Officer Sudheer Doss, PhD. “With the creation of these new industry-wide standards, which will lead to higher quality data capture, improved efficiencies and cost-savings, data sharing and collaboration within the pancreatic cancer scientific community will be enhanced. This can accelerate clinical advancement and improved patient outcomes. We are pleased to partner with CDISC on this important initiative to benefit patients.”

Pancreatic cancer is a devastating disease that is too often diagnosed far too late to respond to currently available treatments,” said CDISC President and CEO David R. Bobbitt, MSc, MBA. “CDISC is very pleased to partner with PanCAN to develop the first data standards to drive more meaningful and efficient critical research that will facilitate new treatments. Our work with PanCAN will bring clarity to data.”

The TAUG for pancreatic cancer will be freely available via the CDISC website. A machine-readable version designed to facilitate automation in research studies will be available via the CDISC Library API, which all members of the pancreatic cancer research community will be able to access. The anticipated timeline for completion is two years.

About the Pancreatic Cancer Action Network

The Pancreatic Cancer Action Network (PanCAN) is dedicated to fighting the world’s toughest cancer. In our urgent mission to save lives, we attack pancreatic cancer on all fronts: research, clinical initiatives, patient services and advocacy. Our effort is amplified by a nationwide network of grassroots support. We are determined to improve patient outcomes today and to double pancreatic cancer survival. To learn more about PanCAN, visit pancan.org and follow along on Twitter, Instagram and Facebook.

About CDISC

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20190827005033/en/

CONTACT

Kristin Reynolds

Editorial Director

Pancreatic Cancer Action Network

Phone: 310-706-3348

Email: kreynolds@pancan.org

Ann P. White

Senior Communications Manager

CDISC

Phone: 512-363-5826

Email: awhite@cdisc.org

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