CDISC—an organization that seeks to bring about clarity in clinical research via global collaboration—will release the resulting guidance in the form of an Interim User Guide, which will be made openly available at no cost on the organization website. It is intended to help researchers with data in COVID-19 studies, in order to expedite review, reduce time to market, and boost overall operational efficiency.
Outsourcing-Pharma (OSP) spoke with David Bobbitt, CDISC CEO, about the task force and how it will serve as a resource to researchers seeking ways to combat the virus.
OSP: Could you please give the ‘elevator presentation’ version of CDISC—what it is, its mission, and who’s involved, etc.
DB: CDISC is a standards development organization that creates clarity in clinical research by bringing together a community of experts across the entire healthcare spectrum to develop and advance data standards of the highest quality. With standards that are open and available to all, we enable the accessibility, interoperability, and reusability of research data. From accelerating time to market to driving more discoveries and breakthroughs, CDISC standards clear the way for more meaningful and efficient research that has greater impact on global health.
CDISC standards are required by the US Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), recommended by the China National Medical Products Administration (NMPA) and have been adopted by the world’s leading research organizations. CDISC is a 501(c)(3) global nonprofit charitable organization with hundreds of employees, volunteers, and member organizations around the world.
OSP: Could you please tell me why you launched the task force?
DB: CDISC launched the task force in an effort to support our members and the research community as they work tirelessly to discover critical breakthroughs to treat COVID-19. CDISC recognizes industry organizations are making important business continuity decisions as trials will become more difficult to manage. We are assisting the research community during this uncertain time.
OSP: Please describe the task force—what your plans/goals are, who you plan on inviting/reaching out to, and what projects you’ll tackle.
DB: The task force was launched in late March with the goal of rapidly developing the Interim User Guide and related materials. The task force consisted of several CDISC member organizations and partners, along with CDISC Staff. For a complete list of task force participants and affiliations, please visit https://www.cdisc.org/covid-19-interim-user-guide-task-force.
OSP: Why are tasks force like this important?
DB: Task forces allow us to leverage the collective power of the research community. When the entire research community works together, we have the power to solve issues too complex for any one individual, team, or organization to address alone.
This specific task force included data scientists, researchers, and policy makers from pharma, government agencies, and academic entities. The members bring a depth and breadth that almost no single organization can muster alone.
OSP: Overall, how has COVID-19 impacted the industry?
DB: Industry has needed to react very rapidly to this pandemic – for ongoing studies and to start up new studies for therapeutics and vaccines for COVID-19. Sponsors and CROs have been hit hard in terms of in-flight studies: What if a patient in a research study withdraws because she develops COVID-19 symptoms? What if a patient in a research study is non-compliant with the study protocol due to quarantine?
Research for cancer drugs, vaccines, and many other non-COVID-19 disease categories are continuing—sometimes in fits and starts. We are helping researchers know how to present accurate, clear data in a challenging time. The Interim User Guide and related resources address best practices in how to represent current situations.
OSP: Is there anything you would like to mention about CDISC or the task force that I didn’t ask about?
DB: The Task Force worked together very productively and nimbly throughout the 3.5 week development process. We initially planned to take 45 days. For perspective, CDISC User Guides usually require 18 months to develop, so 45 days was ambitious.
The task force worked to rapidly deliver this User Guide to the research community. The fact that we were able to release it in 3.5 weeks is a testament to the CDISC global community of researchers, data scientists, and leaders from pharmaceutical companies, regulators, and key NGOs rallying our call for a rapid, robust response to COVID-19.
It is our privilege on behalf of CDISC’s members to make these standards, examples, and all related content freely available immediately to all researchers in the world at www.cdisc.org.