Less Than 55% of Pediatric Clinical Trial Results Are Published

In a recent research letter published in JAMA Network Open, Chris A. Rees, MD, MPH, and his colleagues analyzed how pediatric clinical trial results are disseminated or made publicly available. Rees and the other researchers found that less than 55% of pediatric clinical trial results are published within four years of trial completion.

Rees and his team collected data on clinical trials that had received grant funding and had completion dates between January 1, 2017, and December 31, 2019. The researchers also used ClinicalTrials.gov and PubMed to gather information on publishing and result dissemination until June 30, 2022.

According to the research letter, the investigators included 413 studies in this analysis. Those studies had $924,331,671 of funding from the NIH, with the National Institute of Child Health and Human Development and the National Institute of Mental Health contributing 35.8% and 15.3%, respectively.

The JAMA article notes that most pediatric clinical trials in the United States are funded through federal grants through the NIH. While the NIH is the primary funder of this research, only 13% of the annual budget is allocated to pediatric clinical trials.

Based on the research collected, approximately 85.7% of government-funded pediatric clinical trials were registered on ClinicalTrials.gov. Beyond that, only a few pediatric trials, 13.3%, reported results to ClinicalTrials.gov within the first year after the study was completed.

Additionally, only 54.3% of clinical trials were published within four years of the study’s completion. Within two years of trial completion, publication rates are even lower at 28.1%, meaning that less than one-third of pediatric clinical trial results are published within two years.

The availability of research focused on pediatrics is critical for healthcare professionals and pharmaceutical manufacturers to understand how to treat patients. Children’s and adolescents’ reactions to medications and treatment regimens can differ wildly from adults’ reactions.

Beyond accounting for different reactions and pharmacological considerations, pediatric clinical trials must consider legislation dictating trial involvement, the age range of the prospective patient population, and the ethical concerns regarding consent and assent.

As the pediatric clinical trial industry continues to grow — with a projected value of $26.47 billion by 2032, according to Future Market Insights — researchers must acknowledge the extensive work necessary for successful trials.

Data from Clinical and Translational Science estimates that 20% of pediatric clinical trials fail due to inadequate planning; however, data sharing and publication must be regulated for those who succeed.

Rees and his colleagues concluded their letter by saying, “The NIH recently announced plans to increase enforcement activities for trial registration and reporting and to verify adherence to these requirements prior to issuing subsequent awards to NIH-funded investigators. While there is an ethical obligation for timely dissemination of all research involving human participants, this responsibility warrants particular consideration when trials are supported by public funds and enroll pediatric patients.”