COTA, Forms Strategic Real-World Data Research Partnership with the Clinical Research Data Sharing Alliance

COTA joins consortium of biopharma companies, data sharing platforms, academic institutions, and service and technology partners to usher in the next generation of data-driven healthcare

COTA, Inc., an oncology real-world data and analytics company, announced its membership in the Clinical Research Data Sharing Alliance (CRDSA), a nonprofit, cross-industry alliance of biopharma companies, data sharing platforms, academic institutions, and service and technology partners. Member organizations collaborate to accelerate the discovery and delivery of life-saving therapies to patients through the use of high-quality clinical trial and real-world data.

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“Industry and regulators are increasingly looking to leverage the totality of evidence generated from real-world and clinical trial data to advance the drug development and approval process”

COTA was invited to join the Alliance because of a shared vision and belief that broad access to, utilization of, and better understanding of deidentified patient data has the power to transform the research process, improve clinical trials, and, most importantly, benefit patients by improving the quality, speed, and efficiency of drug development.

As the newest member of CRDSA, COTA will participate in the Alliance’s steering committee and the Innovative Trial Design Working Group. The Working Group’s first project will be focused on non-small cell lung cancer (NSCLC). One of the goals of this project is to explore the complementary use of real-world and clinical trial data in research and drug development. Furthermore, the project aims to address gaps and develop consensus standards to inform regulatory guidance when using diverse data types.

“Industry and regulators are increasingly looking to leverage the totality of evidence generated from real-world and clinical trial data to advance the drug development and approval process,” said Aaron Mann, CEO of CRDSA. “As we develop these capabilities, regulators need support, guidance, and multi-stakeholder feedback to create best practices and guidelines for using these diverse multi-modal datasets to support drug approvals, post-market surveillance, and other use cases.”

Since its launch in 2021, CRDSA has published multiple guidance and framework documents, distinguishing itself as a productive and influential industry alliance. The objective of this early work is to support stakeholders in their evaluation of technologies that advance their data-sharing initiatives while highlighting opportunities to further protect patient privacy.

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“Responsible, ethical, and compliant data sharing has the potential to revolutionize healthcare. However, we are still in the early stages when it comes to data standardization, regulatory guidance, and governing policies,” said C.K. Wang, M.D., Chief Medical Officer at COTA. “We are pleased to work with cross-industry groups like CRDSA as they build trust and demonstrate the value of data sharing for all stakeholder groups, particularly patients.”

For more than a decade, COTA has invested in research aimed at bringing clarity to cancer care and treatment for patients, pharma, providers, health plans, and regulators. To date, COTA has collaborated on driving industry-leading cancer research that is grounded in real-world data with organizations such as the U.S. Food and Drug Administration, Friends of Cancer Research, University of Chicago Medicine, UT Southwestern Medical Center, University of Rochester, and more. Most recently, COTA collaborated with the Georgetown Lombardi Comprehensive Cancer Center on research presented at the 2023 ASCO Gastrointestinal Cancers Symposium.

COTA was founded in 2011 to build bridges between clinical care, researchers, life sciences companies, and the regulatory ecosystem. The company’s mission is to create clarity from fragmented and often inaccessible real-world data, using proprietary technology to develop a comprehensive picture of cancer that can be used to advance care and research.

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