ASCO, CancerLinQ LLC and its technology collaborator Concerto HealthAI, and data from the practices that participate in the CancerLinQ® platform will be a part of the upcoming “8th Annual Blueprint for Breakthrough Forum—Validating Real-World Endpoints for an Evolving Regulatory Landscape” one-day forum hosted by Friends of Cancer Research (Friends).
Registration is open for the September 18 event, which will be held at The Ritz Carlton in Washington, D.C.
This meeting is a follow-up to a roundtable Friends hosted earlier this year, in which ASCO participated, to identify key challenges and next steps to describing “how real-world evidence (RWE) can fill evidence gaps about the performance of approved agents used in the real-world setting, including in populations that may not have been included in initial clinical trials.”[i]
A real-world endpoint is a clinical outcome for patients treated in real-world settings that reflects their treatment arc—overall survival, progression-free survival, time to treatment discontinuation, time to progression, etc. The Food and Drug Administration (FDA) and members of the oncology community are examining how clinical data—logged by oncology care team members into electronic health records or captured through medical claims—can be used to assess a particular therapy’s effectiveness while augmenting what is learned from clinical trials, which only include a small slice of the patient population.
Prior to the September 18 meeting, 12 organizations or teams, including the CancerLinQ/Concerto HealthAI team, will contribute data to this unified pilot project, to further characterize how real-world endpoints can fill evidence gaps about the performance of approved treatments. Friends will present the data from all teams at the meeting after which the panelists and meeting participants will comment and pose questions.
CancerLinQ and Concerto HealthAI will be a part of the first panel discussion, “Operationalizing the Use of Real-World Evidence.” CancerLinQ® Deputy Medical Director Wendy Rubinstein, MD, PhD, FACMG, FACP, and Concerto HealthAI Chief Scientific Officer Mark Walker, PhD, will be panel members and will comment on the comprehensive “Real-World Endpoint Analysis” and discuss lessons learned through the team efforts between the two organizations. The CancerLinQ and Concerto HealthAI project examines opportunities and limitations of real-world endpoints in their ability to assess the direction and magnitude of effect sizes among different therapies.
The forum also will include keynote speakers FDA Acting Commissioner Ned Sharpless, MD, and FDA Principal Deputy Commissioner Amy Abernethy, MD, PhD, as well as sessions on:
- Pilot Project Findings: Validating Real-World Endpoints
- Operationalizing the Use of Real-World Datasets (panel discussion)
- Developing a Validation Framework for Real-World Data (panel discussion)
- The Future of Real-World Evidence: Informing Regulatory and Payer Decisions.
Register to attend the forum.