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Leal Health, ("Leal" or "the Company"), formerly known as Trialjectory has announced that the Company presented a poster at this year's American Society of Clinical Oncology (ASCO) Breakthrough Annual Meeting, showcasing the impact of patients' ECOG scores on solid and non-solid tumor clinical trial eligibility. The poster was presented by Lena Lapidot, PhD, RD, medical director at Leal Health.
An Eastern Cooperative Oncology Group (ECOG) score indicates a patient's level of disability through a 0 to 5 scale (0 indicates a fully active patient, while 5 represents a deceased patient) and is a common eligibility criterion used to assess patients for clinical trial enrollment. While pharmaceutical companies developing and executing clinical trials have historically recruited patients in relatively good physical condition (i.e., minimal comorbidities and with a favorable ECOG performance status), many cancer patients have significant disabilities, leading to higher ECOG scores and resulting in their exclusion from clinical trials. Therefore, the strict threshold of ECOG scores for trials results in a skewed representation of real-world patients while also creating massive barriers to enrollment for patients.
Leal's study evaluated the impact of ECOG scores on solid and non-solid tumor clinical trial eligibility. The Company assessed patients on Leal's AI-powered platform and reviewed their self-reported questionnaires, which are the basis for patients' clinical profiles. These profiles include unique factors relevant to clinical trial eligibility, including disease status, stage, biomarkers, treatment history, comorbidities and demographics. To assess the impact of patients' ECOG scores, Leal adjusted the dataset to reflect a better ECOG score per patient while all other parameters remained constant.
Key findings include:
"Our findings show that a patient's cancer type may influence the relationship between ECOG scores and access to clinical trials," said Lapidot. "Adjusting ECOG scores for the better appears to have a greater impact on trial eligibility for patients with solid tumors, as these patients may face more barriers to enrollment due to strict ECOG requirements. Using ECOG scores as a strict criterion for enrolling patients in clinical studies is outdated and detrimental, and we need to ensure that real-world cancer patients are represented. A more nuanced approach is needed to take into account the specific cancer type and its associated physical demands. Leal's mission is to continue identifying any limiting criterion in clinical trial design as a way to raise awareness of how these factors can impact patient recruitment and access to lifesaving treatment."
Leal Health Presents Poster Highlighting Impact of Patient ECOG Scores on Oncology Clinical Trial Eligibility. (2023, August 7). Cision PR Newswire.