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A new standard for pancreatic cancer data
08-27-2019
by DDNews Staff  |  Email the author
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MANHATTAN BEACH, Calif. and AUSTIN, Texas—The Pancreatic Cancer Action Network (PanCAN), a leading pancreatic cancer patient advocacy organization, and CDISC, a global nonprofit dedicated to developing and advancing clinical research data standards of the highest quality, announced today that they have entered into a collaboration to establish the first-ever data standards specifically for pancreatic cancer.  
 
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’s estimated that in 2020, 480,000 new cases will be diagnosed globally. 
 
CDISC and PanCAN plan to 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.
 
“Standardizing clinical research data is especially critical with a disease like pancreatic cancer – time is of the essence for patients participating in clinical trials,” stated Sudheer Doss, Ph.D., PanCAN’s chief data officer. “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.”
 
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.
 
“Pancreatic cancer is a devastating disease that is too often diagnosed far too late to respond to currently available treatments. 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,” added CDISC president and CEO David R. Bobbitt, MSc, MBA.
 
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 of the project is two years.
 
Code: E08271901

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