Abstract
BackgroundIncomplete clinical trials for pediatric drug development result in a lack of adequate scientific evidence for providing appropriate medication to pediatric populations; this is especially true for Japan. Thus, using the European Clinical Trials Database (EudraCT), this study aimed to identify the factors related to the study design and administration that lead to incompletion of clinical trials that included pediatric patients.MethodsWe focused on clinical trials that included patients under the age of 18 registered in the database, named as the European Clinical Trials Database between January 1, 2014, and December 31, 2018. Two groups of trials were identified: “all cases completed” and “not all cases completed,” reflecting whether they were completed in all participating countries/regions or not. To identify the factors of the occurrence of “not all cases completed,” a logistic regression analysis was performed to calculate the odds ratios and 95% confidence intervals. In total, 142 clinical trials (95 “all cases completed” and 47 “not all cases completed”) were analyzed.ResultsThe logistic regression analysis showed the number of countries in which a clinical trial was conducted to be the only significant factor (odds ratio: 1.3; 95% confidence interval: 1.1-1.5); this was identified as the primary factor for the occurrence of “not all cases completed” in the clinical trials that included pediatric patients.ConclusionOur findings suggest that the feasibility of clinical trials that include pediatric patients, such as whether the countries in which the trial is to be conducted are suitable, must be considered prior to the trial.
Highlights
Incomplete clinical trials for pediatric drug development result in a lack of adequate scientific evidence for providing appropriate medication to pediatric populations; this is especially true for Japan
The aim of this study was to identify the factors related to the study design or study administration that was associated with incomplete clinical trials that included pediatric patients, using the European Clinical Trials Database (EudraCT)
We examined whether the clinical trial formed part of a pediatric investigation plan (PIP) authorized by a competent authority, the sponsor type, whether the clinical trial had undergone substantial protocol amendments, whether there were no protocol amendments after starting a clinical trial, whether the clinical trial was interrupted globally, and the trial’s “not all cases completed” status (i.e., “not authorized,” “temporarily halted,” or “prematurely ended”)
Summary
Incomplete clinical trials for pediatric drug development result in a lack of adequate scientific evidence for providing appropriate medication to pediatric populations; this is especially true for Japan. The use of off-label or unlicensed drugs in Japan is entirely excluded from side effects therapy according to the Relief System for Sufferers from Adverse Drug Reactions by the Law for the Pharmaceuticals and Medical Devices Agency. This system denies any opportunity for recompense from the regulatory agency, even when side effects emerge in pediatric patients [2]
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