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Research Article
Tao Zhang
Department of Epidemiology and Health Statistics, West China School of Public Health and West China fourth Hospital, Sichuan University, Sichuan
Corresponding Author
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This work is licensed under a CC BY 4.0 License. Read Full License
Background Since the national clinical trials registry (ClinicalTrials.gov) launched in February 2000, more than 300,000 trials have been registered. However, little is known about the registered pediatric clinical trials with regarding to characteristics, trends and quality over time.
Methods To describe patterns of the registered pediatric clinical trials, a dataset of trials involving children was downloaded from ClinicalTrials.gov on August 1st, 2020. To further trace the registration of pediatric disease types, we selected the top four infectious diseases to describe their trends over time. To examine reporting completion rate of clinical trial results, we identified completed studies and then observed the proportion of trials subject to reporting.
Results Between 2000 and 2019, a total of 53,060 pediatric trials were registered at ClinicalTrials.gov, including 36,136 (68.1%) interventional trials and 6,692(31.5%) observational trials. The number of them increased significantly over time. Meanwhile, the number of missing data elements has generally declined.Most interventional pediatric trials were single center (61.4%), small-scale(58.9%), randomized (66.0%), and none masking(56.9%), with fewer drug trials being conducted over time.Many pediatric clinical trials were funded by other organizations.The proportion of trials complianced with reporting results varied by study type, trial phase and lead sponsor.
Conclusion The pediatric clinical trial registration are on the rise, with significant changes in registration information such as trial type, main purpose, and intervention characteristics, which can help stakeholders inform the decision to conduct trials in children. Although the proportion of missing data was decreasing, the proportion of reporting results remained to be improved.
Keywords
ClinicalTrials.gov, Pediatrics, Clinical trials, Trial registries
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On 23 Jan, 2021
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Received 12 Jan, 2021
Reviewer #19 agreed
On 06 Jan, 2021
Reviewer #7 agreed
On 06 Jan, 2021
Reviewer #24 agreed
On 06 Jan, 2021
Reviewer #23 agreed
On 06 Jan, 2021
Reviewer #27 agreed
On 06 Jan, 2021
Reviewer #22 agreed
On 06 Jan, 2021
Reviewer #10 agreed
On 06 Jan, 2021
Reviewer #5 agreed
On 06 Jan, 2021
Reviewer #21 agreed
On 06 Jan, 2021
Reviewer #20 agreed
On 06 Jan, 2021
Reviewer #11 agreed
On 06 Jan, 2021
Reviewer #25 agreed
On 06 Jan, 2021
Reviewer #1 agreed
On 06 Jan, 2021
Reviewer #2 agreed
On 06 Jan, 2021
Reviewer #3 agreed
On 06 Jan, 2021
Reviewer #6 agreed
On 06 Jan, 2021
Reviewer #26 agreed
On 06 Jan, 2021
Reviewer #13 agreed
On 06 Jan, 2021
Reviewer #12 agreed
On 06 Jan, 2021
Reviewers invited
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On 31 Dec, 2020
Editor invited
On 31 Dec, 2020
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On 31 Dec, 2020
First submitted
On 29 Dec, 2020
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Subject Areas
Pediatrics
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This preprint is under consideration at BMC Pediatrics. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Research Article
Tao Zhang
Department of Epidemiology and Health Statistics, West China School of Public Health and West China fourth Hospital, Sichuan University, Sichuan
Corresponding Author
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Under Review
Version 1
Posted 05 Jan, 2021
No community comments so far
Editorial decision: Major revision
On 15 Feb, 2021
Review #3 received
Received 09 Feb, 2021
Review #2 received
Received 09 Feb, 2021
Reviewer #4 agreed
On 23 Jan, 2021
Review #13 received
Received 12 Jan, 2021
Review #1 received
Received 12 Jan, 2021
Review #18 received
Received 12 Jan, 2021
Review #17 received
Received 12 Jan, 2021
Review #21 received
Received 12 Jan, 2021
Review #16 received
Received 12 Jan, 2021
Review #4 received
Received 12 Jan, 2021
Review #15 received
Received 12 Jan, 2021
Review #14 received
Received 12 Jan, 2021
Review #5 received
Received 12 Jan, 2021
Review #19 received
Received 12 Jan, 2021
Review #20 received
Received 12 Jan, 2021
Review #7 received
Received 12 Jan, 2021
Review #6 received
Received 12 Jan, 2021
Reviewer #19 agreed
On 06 Jan, 2021
Reviewer #7 agreed
On 06 Jan, 2021
Reviewer #24 agreed
On 06 Jan, 2021
Reviewer #23 agreed
On 06 Jan, 2021
Reviewer #27 agreed
On 06 Jan, 2021
Reviewer #22 agreed
On 06 Jan, 2021
Reviewer #10 agreed
On 06 Jan, 2021
Reviewer #5 agreed
On 06 Jan, 2021
Reviewer #21 agreed
On 06 Jan, 2021
Reviewer #20 agreed
On 06 Jan, 2021
Reviewer #11 agreed
On 06 Jan, 2021
Reviewer #25 agreed
On 06 Jan, 2021
Reviewer #1 agreed
On 06 Jan, 2021
Reviewer #2 agreed
On 06 Jan, 2021
Reviewer #3 agreed
On 06 Jan, 2021
Reviewer #6 agreed
On 06 Jan, 2021
Reviewer #26 agreed
On 06 Jan, 2021
Reviewer #13 agreed
On 06 Jan, 2021
Reviewer #12 agreed
On 06 Jan, 2021
Reviewers invited
Invitations sent on 01 Jan, 2021
Editor assigned
On 31 Dec, 2020
Editor invited
On 31 Dec, 2020
Submission checks complete
On 31 Dec, 2020
First submitted
On 29 Dec, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Pediatrics
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background Since the national clinical trials registry (ClinicalTrials.gov) launched in February 2000, more than 300,000 trials have been registered. However, little is known about the registered pediatric clinical trials with regarding to characteristics, trends and quality over time.
Methods To describe patterns of the registered pediatric clinical trials, a dataset of trials involving children was downloaded from ClinicalTrials.gov on August 1st, 2020. To further trace the registration of pediatric disease types, we selected the top four infectious diseases to describe their trends over time. To examine reporting completion rate of clinical trial results, we identified completed studies and then observed the proportion of trials subject to reporting.
Results Between 2000 and 2019, a total of 53,060 pediatric trials were registered at ClinicalTrials.gov, including 36,136 (68.1%) interventional trials and 6,692(31.5%) observational trials. The number of them increased significantly over time. Meanwhile, the number of missing data elements has generally declined.Most interventional pediatric trials were single center (61.4%), small-scale(58.9%), randomized (66.0%), and none masking(56.9%), with fewer drug trials being conducted over time.Many pediatric clinical trials were funded by other organizations.The proportion of trials complianced with reporting results varied by study type, trial phase and lead sponsor.
Conclusion The pediatric clinical trial registration are on the rise, with significant changes in registration information such as trial type, main purpose, and intervention characteristics, which can help stakeholders inform the decision to conduct trials in children. Although the proportion of missing data was decreasing, the proportion of reporting results remained to be improved.
Figure 1
Figure 2
Figure 3
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