CDISC has launched a task force to rapidly develop guidance on standardizing COVID-19 research data with the participation of several member companies. This guidance will be released in the form of an Interim User Guide and will be made freely available on the CDISC website. Researchers around the world can leverage the User Guide to represent data in studies pertaining to COVID-19 to expedite the regulatory review process, reduce time to market, and drive operational efficiencies within their organizations. US FDA is aware of and observing the work of the task force.
As part of its work, the task force will also address controlled terminology necessary to represent changes in current inflight studies where patients acquire COVID-19 or where the ability to assess patient conditions are impacted by the pandemic. These best practices will be available to CDISC members.
Implementing CDISC standards allows data to be structured effectively and easily analyzed, leaving more time to focus on discoveries that will have invaluable impact on clinical research and global health. CDISC will leverage our existing work on virology and infectious disease therapeutic areas to expedite development.
“CDISC clinical data standards ensure that safe, effective pharmaceuticals and vaccines come to market faster,” said Peter Van Reusel, CDISC Chief Standards Officer. “We are utilizing all available resources to ensure standards of the highest quality are available for those researchers leading the effort to halt novel coronavirus. For this task force, we are bypassing our normal development timeline to ensure this User Guide is available within 45 days.”
“It is largely business as usual at CDISC. Staff and volunteer teams are working remotely. Our work remains essential to supporting the development of potential treatments for COVID-19 as well as all other human health problems,” stated David R. Bobbitt, CDISC President and CEO.
“CDISC’s focused efforts toward the rapid development of standards for COVID-19 are aligned with CDISC’s mission to enable information system interoperability to improve medical research,” said Jonathan Zung, Executive Vice President, WCG and CDISC Board Chair. “CDISC is particularly well-prepared to develop these vital clinical standards during this time of uncertainty. We appreciate the hard work of our staff, volunteers and CDISC’s executive team to ensure quality global data standards are available to develop treatments in this pandemic.”
“Now is the time to be bold and to support researchers more than ever, and we invite other member companies with a COVID-19 vaccine or interventional product to join this effort,” said Bobbitt. “CDISC will continue to support our membership as they work tirelessly to discover critical breakthroughs. We made a major investment last year in CDISC Library and API, which can be accessed remotely to deliver CDISC standards metadata to software applications that automate standards-based processes. We are seeing an increase in demand for the API from commercial tool developers around the globe.”
“As a founding member of CDISC, Roche has supported CDISC’s mission since its inception. We are pleased to collaborate on developing these new clinical data standards to drive research forward for COVID-19,” said Jonathan Chainey, Global Head, Data Standards, Roche. “Roche is currently using CDISC standards to pursue testing to relabel Actemra for novel coronavirus. We hope our Actemra product can offer help to those suffering from COVID-19.”
CDISC recognizes industry organizations are making important business continuity decisions as trials will become more difficult to manage. We are ready to assist the research community however necessary during this uncertain time. We continue to offer such resources as online education courses and the CDISC Library API, which allows remote, cloud-based access to CDISC standards. Please contact firstname.lastname@example.org if your organization needs any specific help with a COVID-19 study or access to the API.
CDISC remains committed to representing our community of members, partners and other stakeholders, and advocate for data standardization with all regulators, including US FDA, Japan PMDA, and China NMPA. We are grateful for our members whose support allows us to develop our standards, which serve the global research community.
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 and is headquartered in Austin, Texas, with hundreds of employees, volunteers, and member organizations around the world. www.cdisc.org.