Researchers at Boston Children’s Hospital say the efforts of children, as well as researchers and funding sources, in hundreds of clinical trials are being wasted by studies that are either not finished or never published.
Hundreds of clinical trials involving children are discontinued early, and even more that are completed never get published, despite legislative initiatives encouraging more pediatric studies across the country, according to a review of medical literature.
Legislative initiatives have been launched to encourage more studies with children because of historical issues enrolling children, but researchers found pediatric studies are abandoned at nearly the same rates as trials involving adults.
For the study, published in the journal Pediatrics, the researchers followed up on 559 clinical trials registered at ClinicalTrials.gov between 2008 and 2010.
Overall, 104 trials, or 19 percent of those tracked, were discontinued early with 37 percent of those abandoned because researchers could not find enough patients to participate. The researchers found, however, that trials were less likely to be stopped if funded by companies instead of academic institutions.
Of 455 completed trials, 30 percent — or 136 — were not published, erasing the results of 69,165 children in the studies. Of these, the researchers found studies funded by private companies were more than twice as likely not to be published than those sponsored by academic institutions.
The researchers suggest resources be created to make sure the results of trials are utilized for something, rather than discarded and forgotten, proposing researchers in unpublished trials either commit to publish within a year of abandoning a study or provide public access to the data.
While they note it can be difficult to analyze and use data from other researchers’ studies, the idea that efforts of both participants and scientists not be wasted is important, they say.
“Our findings are in line with previously published studies focusing on adult trials, which may speak to how commonplace discontinuation and non-publication are in medical research in general,” Dr. Natalie Pica, a researcher at Boston Children’s Hospital, said in a press release. “We need to make sure that when children participate in clinical trials, their efforts are contributing to broader scientific knowledge.”