One in Six Patients in Phase 2 Cancer Trials Receive Drug When Eventually Approved
By Lori Solomon HealthDay Reporter
WEDNESDAY, Feb. 26, 2025 -- 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.
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.
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.
"With respect to consent, many educational materials emphasize that trials present an opportunity to receive tomorrow’s 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."
Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.
© 2025 HealthDay. All rights reserved.
Posted February 2025
Read this next
ASCO: Disease-Free Survival Prolonged With Exercise Program in Colon Cancer
TUESDAY, June 3, 2025 -- For patients with resected colon cancer who have completed adjuvant chemotherapy, a three-year structured exercise program results in significantly longer...
Caffeine Intake in Midlife Linked to Healthy Aging in Women
TUESDAY, June 3, 2025 -- For women, caffeine and regular coffee intake in midlife is associated with increased odds of healthy aging (HA), according to a study presented at...
Subarachnoid Bleed One of the Most Common Cardiovascular, Neurologic Causes of Death
TUESDAY, June 3, 2025 -- Nontraumatic subarachnoid hemorrhage (SAH) remains one of the most common cardiovascular and neurological causes of death and disabilities in the world...
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.