Concerto HealthAI Real World Data Used to Demonstrate Positive Impact of Broadened vs. Traditional Eligibility Criteria

Research presented as part of press program abstract at 2019 ASCO Annual Meeting;

Various inclusion/exclusion criteria explored to understand impact on cohort selection, sample size, line of therapy and patient outcomes;

Research authors “urge all clinical trial sponsors to adopt these criteria.”

BOSTON – June 3, 2019 – Concerto HealthAI, a leading next-generation integrated Real-World Data (RWD) and technology company for precision evidence, announced findings from RWD analysis of patients with advanced non-small cell lung cancer (aNSCLC) that demonstrate broadening clinical trial eligibility criteria would increase by nearly 46% the number of patients who could participate and potentially bring significant benefit to patients.

These findings were presented today as an oral presentation (Abstract #LBA108) during a Clinical Science Symposium focused on using RWD to advance research and care at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting. Concerto HealthAI provided RWD and analysis to ASCO’s CancerLinQ to support the research collaboration between ASCO and FDA.

This innovative research demonstrates the validity of Concerto HealthAI’s technology-enabled RWD to develop powerful RWE solutions that bring an understanding of patients to clinical researchers and regulators at a speed and confidence-level not possible with traditional research methods. The potential impacts of broadened eligibility criteria include accelerated accrual, a more equitable balance between drug toxicity and access to clinical trials for less fit patients and improved overall patient representation to be more reflective of real-world use.

“Patient recruitment into clinical trials remains one of the hardest problems to solve for both patients and clinical researchers and only gets worse for subpopulations with rare cancers,” said Jeff Elton, Ph.D. and CEO of Concerto HealthAI. “Our rapid-query engineered RWD products are enabling researchers to see the impacts of eligibility criteria on their research protocol in real-time and in ways that let them reevaluate and change their study designs quickly and efficiently to include more patients. These research findings in particular underscore this aspect of how our RWD and technology identifies more eligible patients for more successful clinical trials.”

For this research, a retrospective observational analysis was conducted on a deidentified ASCO CancerLinQ Discovery® dataset of 10,500 aNSCLC patients. Researchers compared existing traditional clinical trial eligibility criteria against expanded criteria recommended by ASCO and Friends of Cancer Research, an advocacy organization driving collaboration to accelerate lifesaving treatments to patients, to determine the impact on overall patient population, demographics and data generalizability.

“In general, modern anti-neoplastic agents are becoming more effective with reduced toxicity, therefore it makes sense that patients with traditional exclusion criteria such as stable brain metastases, concurrent cancers, and moderately diminished kidney function should be able to participate in clinical trials,” said Wendy Rubinstein, M.D., Ph.D., CancerLinQ’s Deputy Medical Director and a lead author on these studies. “These findings show just how many more patients would be eligible with expanded criteria and we encourage clinical trial sponsors to adopt these criteria that have been advanced by patient advocates, FDA, NCI, and ASCO.”

“Given the number of experimental therapies being tested for NSCLC, and in oncology more broadly, there may not be enough patients to complete some clinical trials so we need to look at where and how we can most effectively expand the patient pool for improved clinical investigation and relevance,” said Edward Stepanski, Ph.D., a co-author on the abstract and Chief Operating Officer of Concerto HealthAI’s Outcomes Science group. “This approach provides an opportunity to better align clinical investigation with real-world settings and patient demographics to not only improve the accuracy of data guiding regulators and clinical development approaches across the industry, but also serve as a model for other therapeutic categories beyond oncology.”