IMAGE: Systematic review and meta-analysis finds 1 in 10 children who enroll in pediatric phase I cancer trials are improved after the trial, and 1 in 50 die from drug-related complications… view more
Credit: National Cancer Institute, Wikimedia
On average, 1 in 10 children who enroll in pediatric phase I cancer trials are improved after the trial, and 1 in 50 die from drug-related complications, according to a new systematic review and meta-analysis published this week in PLOS Medicine by Jonathan Kimmelman from McGill University, Canada, and colleagues.
Pediatric phase I trials are critical for establishing the safety and dosing of anti-cancer drugs in children. National and international regulations, however, establish limits on allowable risk for research involving minors. In the new study, researchers systematically searched for pediatric phase I cancer studies published between 2004 and 2015. They identified 170 studies involving 4,604 patients, and pooled the objective response rates and the occurrence of grade 3, 4, or 5 (fatal) drug-related adverse events.
Overall, the response rate among all trials was 10.29% (95% CI 8.33 to 12.25) but the rate was significantly different for solid tumors (3.17, 95% CI 2.62 to 3.72) compared to hematological malignancies (27.90, 95% CI
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