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. 2021 Mar 12;22(1):204.
doi: 10.1186/s13063-021-05143-6.

Study factors associated with the incompletion of clinical trials that include pediatric patients: a retrospective analysis of the European Clinical Trials Database and a lesson from the European region

Nanae Tanemura  1 , Tsuyoshi Sasaki  2 , Junko Sato  3 , Hisashi Urushihara  4
Affiliations

Study factors associated with the incompletion of clinical trials that include pediatric patients: a retrospective analysis of the European Clinical Trials Database and a lesson from the European region

Nanae Tanemura et al. Trials. .

Abstract

Background: 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. 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.

Methods: We 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.

Results: The 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.

Conclusion: Our 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.

Keywords: Drug development; Pediatric clinical trial; Pediatric investigation plan; Study administration; Study design.

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Conflict of interest statement

TS has received speakers’ honoraria from Daiichi Sankyo, Eli Lilly, Glaxo Smith Kline, Novartis, Janssen, Otsuka, Shionogi, Shire, Takeda, Taisho, and Tanabe Mitsubishi, and has also received research support from Novartis, Otsuka, Shionogi, and Taisho (from April 2014 to December 2019). HU is a consultant of Eisai and Boehringer Ingelheim. He has received a research grant from Shionogi and Senju pharmaceutical. Additionally, he has received research funds from Daiichi Sankyo, Tanabe Mitsubishi, and Astellas. No financial or non-financial benefits have been or will be received by NT or JS from any party related directly or indirectly to the subject of this article.

Figures

Fig. 1
Fig. 1
Flow diagram for study selection
See this image and copyright information in PMC

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