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Risk and surrogate benefit for pediatric Phase I trials in oncology: A systematic review with meta-analysis.

07:00 EST 20th February 2018 | BioPortfolio

Summary of "Risk and surrogate benefit for pediatric Phase I trials in oncology: A systematic review with meta-analysis."

Pediatric Phase I cancer trials are critical for establishing the safety and dosing of anti-cancer treatments in children. Their implementation, however, must contend with the rarity of many pediatric cancers and limits on allowable risk in minors. The aim of this study is to describe the risk and benefit for pediatric cancer Phase I trials.

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This article was published in the following journal.

Name: PLoS medicine
ISSN: 1549-1676
Pages: e1002505

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The science concerned with the benefit and risk of drugs used in populations and the analysis of the outcomes of drug therapies. Pharmacoepidemiologic data come from both clinical trials and epidemiological studies with emphasis on methods for the detection and evaluation of drug-related adverse effects, assessment of risk vs benefit ratios in drug therapy, patterns of drug utilization, the cost-effectiveness of specific drugs, methodology of postmarketing surveillance, and the relation between pharmacoepidemiology and the formulation and interpretation of regulatory guidelines. (Pharmacoepidemiol Drug Saf 1992;1(1); J Pharmacoepidemiol 1990;1(1))

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