Proportion increases when considering off-label use but drops when considering drugs with substantial clinical benefit<\/p>\n<\/h3>\n
By Lori Solomon HealthDay Reporter<\/b>
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WEDNESDAY, Feb. 26, 2025 (HealthDay News) — One in six patients in phase 2 clinical cancer trials receives treatments that are eventually approved, according to a study published online Feb. 25 in the Journal of the National Cancer Institute<\/em>.<\/p>\n Charlotte Ouimet, from the McGill University School of Population and Global Health in Montreal, and colleagues assessed the probability that patients in phase 2 trials receive treatment that eventually advances to U.S. Food and Drug Administration approval for their condition. The analysis included a random sample from 400 trials identified in Clinicaltrials.gov for cancer phase 2 trials initiated between Nov. 1, 2012, and Nov. 1, 2015.<\/p>\n The researchers found that among 25,002 patient-participants in 608 specific treatment cohorts, 16.2 percent of patients received a treatment that advanced to FDA approval. When considering National Comprehensive Cancer Network off-label recommendations, the therapeutic proportion increased to 19.4 percent but decreased to 9.3 percent for FDA-approved regimens that are considered of substantial clinical benefit by the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale. There were no statistical differences in proportions based on drug class, trial phase, or sponsorship.<\/p>\n “With respect to consent, many educational materials emphasize that trials present an opportunity to receive tomorrow\u2019s treatments,” the authors write. “Our findings move beyond such nondescript statements — namely, that by entering a phase 2 trial, a patient has a one in six chance of receiving a treatment that will later be approved for their condition.”<\/p>\n