Company Found ECOG Scores Restrict Patient Access to Clinical Trials and Prevent Trials from Accurately Representing Real-World Cancer Patient Population
NEW YORK, Feb. 21, 2023 /PRNewswire/ -- Leal Health ("Leal" or "the Company"), formerly known as Trialjectory, an AI-powered decision support platform that democratizes patient access to advanced cancer treatments and empowers the pharmaceutical and biotech industry to execute patient-centric clinical trials, announced today that the Company presented a poster on the negative impact of Eastern Cooperative Oncology Group (ECOG) performance status scores on cancer patients' eligibility to enroll in clinical trials at the American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium. The poster, titled "ECOG score as a barrier for clinical trial eligibility in the patient population with genitourinary cancer: Is it time to adapt this criterion to real-world data?" was presented by Liat Edry-Botzer, Ph.D., Medical Director at Leal Health.
An ECOG score, which 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), is a common eligibility criterion used to assess patients for clinical trial enrollment. 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 score). This is despite the fact that many cancer patients have significant disability, manifesting in higher ECOG scores and resulting in their exclusion from clinical trials.
To assess the impact of a patient's ECOG score on clinical trial eligibility, Leal analyzed ECOG performance scores for two genitourinary cancers patients (prostate and urinary bladder cancer) who used Leal's AI-powered platform to find relevant clinical trials online. Leal adjusted the dataset to reflect a higher ECOG score per patient and discovered a significant and consistent increase in the number of trial matches. Simply decreasing the ECOG score from 3 to 2 resulted in a 262 and 111 percent increase in trial matches for prostate cancer and urinary bladder cancer patients, respectively. Additionally, among prostate and urinary bladder cancer patients editing the ECOG score from 2 to 1 resulted in 107 and 68 percent increase in trial matches, respectively.
"Conducting trials that are weighted toward testing relatively healthy people, as opposed to including specific patient populations that these drugs are ultimately intended to treat, have a huge impact on the relevance of trial outcomes, and the drug's safety and efficacy profile. Furthermore, if we exclude patients based on their subjective ECOG scores alone, we are excluding high potential clinical trial seekers whose ECOG score may be temporarily negatively impacted by cancer treatments," said Dr. Edry-Botzer. "The recent mandate from the FDA directing clinical trials to include patients from underrepresented populations should not be limited to race and ethnicity; it should be expanded to include also cancer patients with real-world, worse ECOG status that are looking for new treatment options. Applying strict eligibility criteria for clinical trials, including ECOG scores, rather than assessing real-world patient data creates massive barriers to enrollment for cancer patients everywhere."
About Leal Health
Leal Health, formerly known as Trialjectory, is a patient-first, AI-powered decision support platform dedicated to improving cancer treatment. Working directly with patients, healthcare providers and pharmaceutical companies, Leal democratizes access to advanced cancer treatment and empowers the pharmaceutical and biotech industry to execute patient-centric clinical trials. The Company has been recognized by TIME as one of "The 100 Best Inventions of 2020" and named an honoree in the AI and data category for Fast Company's "2021 World-Changing Ideas Awards." For more information, please visit www.leal.health, and follow the Company on Facebook and LinkedIn.
SOURCE Leal Health
