COTA Joins Multistakeholder Clinical Research Data Sharing Alliance

The real-world oncology data and analytics company COTA today announced its partnership with the Clinical Research Data Sharing Alliance (CRDSA), a non-profit, multi-stakeholder consortium that aims to accelerate progress in cancer therapy development through increased data sharing.

CRDSA was established in 2021 and comprises biopharmaceutical companies, data sharing platforms, academic institutions, and service and technology partners whose common goal is to facilitate clinical data sharing. Broadening access to deidentified patient data can help improve the overall research process and make cancer drug development more efficient, according to a statement from COTA.

COTA will be part of the CRDSA steering committee and the Innovative Trial Design Working Group, which aims to develop novel approaches to trial design that include data reuse, as well as drive policy changes that make innovative clinical trial execution possible.

“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,” C.K. Wang, MD, chief medical officer at COTA, said in a statement. “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.”

The first Innovative Trial Design Working Group project involving COTA, the Supplemental Controls Demonstration Project, will focus on non–small-cell lung cancer research and drug development. The project aims to address gaps in guidance and create standards that can inform updated health authority guidance on the use of patient-level data from clinical trials and the real world.

The project builds upon FDA work by CRDSA members and will address “data provenance, study and subject selection methodologies, and multi-modal analysis exploring the synergistic reuse of clinical trial data and [real-world data],” according to the official project description.

CRDSA has already published multiple guidance and framework documents intended to support stakeholders as they explore technologies that enhance data sharing while ensuring and further improving patient privacy. These goals are in line with those of COTA, which was founded with a mission of organizing previously inaccessible or fragmented real-world data to forward cancer research and care.

“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.”