While all peer-reviewed pediatric journals look forward to receiving well-done clinical trials, the number of pediatric trials is much smaller than the number of adult clinical studies. An important reality is that many studies are not completed. This could be due to the challenge of enrolling children, the relative low prevalence for high-priority conditions, and a lack of funding. What proportion of trials registered with ClinicalTrials.gov, one of the largest international databases of clinical trials, are completed and ultimately published? These were the questions that Brewster et al (10.1542/peds.2021-052557) explored in an interesting article being early-released this month in Pediatrics.
The authors share with us their findings of all pediatric (≤18 years) registered in ClinicalTrials.gov between 2007 and 2020. Of the 13,259 registered clinical trials, 11.1% ended early due largely to recruitment failure. What is even more concerning is that only 23.5% of completed trials reported their results publicly and only 38.8% published their results within three years of study completion. The authors provide detailed information, including evaluation by industry vs. government funding.
What are the barriers to conducting clinical trials and reporting the findings, and what can we do to improve the process? To help answer the concerns raised by the Brewster et al, we invited Dr. Florence Bourgeois from the Computational Health Informatics Program at Boston Children’s Hospital to weigh in with an accompanying commentary (10.1542/peds.2021-055815). Dr. Bourgeois provides a number of important and feasible suggestions to improve pediatric clinical trial infrastructure, such as increasing the sample sizes of trials by having investigators pool data through collaborative networks and organizing clinical trials across multiple institutions. She also notes how data in electronic health records and pharmacy claims can be better leveraged. Dr. Bourgeiois also notes the importance of improving our systems of data sharing and reuse. Finally having a standard set of required metrics to monitor the progress of trials is another great suggestion to ensure completion of trials.
If you want to get a great overview of the strengths and limitations of the pediatric clinical trial enterprise, then give this study and commentary a trial run by linking to it and learning more.