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Clinical trials in children: many results go unreported

A group of US researchers have determined the proportion of clinical trials in children that were stopped prematurely, as well as the proportion of completed trials whose results were not reported.

Their study included 13 259 clinical trials, registered in the public US clinical trial registry ClinicalTrials.gov between 2007 and 2020. One in ten of the trials included in the study had been stopped prematurely. The reason most often given was difficulty recruiting participants. The organisations that funded the trials (governments, universities, pharmaceutical companies and others) gave a number of other reasons for failing to complete a trial.

The incentives in place in the United States appear insufficiently effective at encouraging pharmaceutical companies to invest in clinical trials in children, and to make the detailed data from these trials available so that better healthcare decisions can be made. The situation is similar in the European Union. There will be an opportunity to improve it with the revision of Europe's pharmaceutical legislation, launched by the European Commission in late April 2023.

©Prescrire 1 July 2023

Source: "Clinical trials in children: many results go unreported" Prescrire International 2023; 32 (250): 195. Free.

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