March 2022: Sponsors Fail to Upload Pediatric Clinical Trials on ClinicalTrials.gov – A TransperiMED Report

An article “Where are the results for these 2,272 clinical trials involving children? ” was published on March 29, 2022 on TranspariMED.

This article, states that around 2,272 clinical trials involving children had not made their results public within three years of trial completion. On examining trial registries and academic journals, it was found that almost half (48%) of the clinical trial results could not be traced. The article also informs that academic trials (45%) involving children were much less likely make their results public within three years than trials sponsored by government (59%) or industry (61%). This article was originally published by the American Academy of Pediatrics – Early Discontinuation, Results Reporting, and Publication of Pediatric Clinical Trials.

According to the Final rule regulation for ClinicalTrials.gov, results information submission requirements must be submitted by the responsible party no later than 1 year after the primary completion date. The ClinicalTrials.gov registry also enables researchers to rapidly make results public without compromising their ability to later publish the same results in a medical journal.

As per the article, the study included all interventional pediatric trials, including trials run abroad by non-US sponsors. It excluded trials that involved both children and adults. The study analyzed a total of 4,657 pediatric trials registered on ClinicalTrials.gov from October 2007 that had been completed by March 2017. Of these, only 24% had reported results to the ClinicalTrials.gov registry, and 39% had published results in a peer-reviewed Journal, within three years of completion.

The article concluded that targeted efforts are needed to support trial completion and timely results dissemination toward strengthening evidence-based pediatric medicine.

More information can be found here