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Delayed pediatric trials

The lag between first-in-human and first-in-child clinical trials

Cancer drugs approved by the U.S. Food and Drug Administration (FDA) took a median of 6.5 years to go from the first clinical trial in adults to the first trial in children, according to a study at the Dana-Farber/Boston Children's Cancer and Blood Disorders Center. The study was published in the May issue of the European Journal of Cancer.

The team at Dana-Farber/Boston Children's conducted a systematic analysis of the time from first-in-human trials to first-in-child trials of agents first approved by the FDA for any oncology indication from 1997 to 2017. The investigators utilized clinical trials registry data, published literature and oncology abstracts to identify relevant trials and start dates.
In that timeframe, 126 drugs received initial FDA approval for an oncology indication. After excluding hormonal modulators (not relevant to children's cancers), 117 agents remained for analysis. 15 of 117 drugs (12.8%) had not yet had a pediatric trial, while 6 of 117 drugs (5.1%) included children in the initial FDA approval.


The data showed a median 6.5-year lag between first-in-human and first-in-child clinical trials, with a range of 0 to 27.7 years.
These results provide a benchmark against which to evaluate recent initiatives designed to hasten drug development relevant to children with cancer.
The Instituto de Oncología Intervencionista (Interventionist Oncology Institute) only uses drugs COFEPRIS (Mexican Federal Commission for the Protection Against Sanitary Risk) and FDA (U.S. Food and Drug Administration) approved. From the onset of the interventionist oncology program, the course of treatment has maintained a basic structure of chemotherapeutic drugs. However, IDOI Mexico constantly evaluates new medications, on the lookout for those that could deliver better results.