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Clinical trials in children too often go uncompleted or unpublished, according to a pair of researchers.
The duo evaluated nearly 560 pediatric trials and found that 19% were discontinued early. Of the trials that were completed, 30% remained unpublished several years later.
Industry-sponsored trials were more likely to be completed than trials sponsored by academic institutions. However, completed trials sponsored by industry were less likely to be published than trials sponsored by academia.
“Our findings are in line with previously published studies focusing on adult trials, which may speak to how commonplace discontinuation and non-publication are in medical research in general,” said study author Natalie Pica, MD, PhD, of Boston Children’s Hospital in Massachusetts.
She and Florence Bourgeois, MD, also of Boston Children’s Hospital, reported these findings in Pediatrics.
The researchers tracked 559 randomized, controlled pediatric trials registered on ClinicalTrials.gov from 2008 to 2010 and whose final status (completed or discontinued) was confirmed by the end of 2012.
The pair then searched for related peer-reviewed articles published through September 1, 2015. When no publication could be found, the researchers inquired with study investigators and sponsors via email.
Of the 559 trials, 104 (19%) were discontinued early. Two-thirds of these had enrolled participants.
Of the 455 completed trials, 136 (30%) remained unpublished after an average of 58 months post-completion. However, 42 of these (31%) did have results posted on ClinicalTrials.gov.
Of the 104 discontinued trials, 39% were sponsored by industry, and 55% were sponsored by academic institutions. (The rest were funded by other sources.)
Two years after trial completion, academia-sponsored trials accounted for 30% of unpublished trials, and industry-sponsored trials accounted for 63%.
Three years after trial completion, academia-sponsored trials accounted for 23% of unpublished trials, and industry-sponsored trials accounted for 70%.
In a multivariate analysis, the likelihood of non-publication was more than doubled for industry-sponsored trials 2 years after completion (odds ratio=2.21) and more than tripled 3 years after completion (odds ratio=3.12).
Overall, more than 8000 children were enrolled in trials that were never completed, and more than 69,000 children were enrolled in completed trials that were never published.
“This is the first study to look systematically at discontinuation and nonpublication of interventional pediatric clinical trials,” Dr Bourgeois said.
“A number of legislative initiatives have been implemented to increase the study of interventions in children. Now, we need to make sure that the proper resources are in place to ensure that information gleaned from these studies reaches the scientific community.”
One proposed initiative cited by Drs Bourgeois and Pica is RIAT (Restoring Invisible and Abandoned Trials), which is supported by some high-profile journals. RIAT invites researchers with unpublished trials to either commit to publish within a year or provide public access to their data.
“It’s hard to reanalyze others’ data,” Dr Pica noted, “but this may be a useful mechanism to make sure that findings from completed trials are disseminated in the medical literature.” 
Photo by Logan Tuttle
Clinical trials in children too often go uncompleted or unpublished, according to a pair of researchers.
The duo evaluated nearly 560 pediatric trials and found that 19% were discontinued early. Of the trials that were completed, 30% remained unpublished several years later.
Industry-sponsored trials were more likely to be completed than trials sponsored by academic institutions. However, completed trials sponsored by industry were less likely to be published than trials sponsored by academia.
“Our findings are in line with previously published studies focusing on adult trials, which may speak to how commonplace discontinuation and non-publication are in medical research in general,” said study author Natalie Pica, MD, PhD, of Boston Children’s Hospital in Massachusetts.
She and Florence Bourgeois, MD, also of Boston Children’s Hospital, reported these findings in Pediatrics.
The researchers tracked 559 randomized, controlled pediatric trials registered on ClinicalTrials.gov from 2008 to 2010 and whose final status (completed or discontinued) was confirmed by the end of 2012.
The pair then searched for related peer-reviewed articles published through September 1, 2015. When no publication could be found, the researchers inquired with study investigators and sponsors via email.
Of the 559 trials, 104 (19%) were discontinued early. Two-thirds of these had enrolled participants.
Of the 455 completed trials, 136 (30%) remained unpublished after an average of 58 months post-completion. However, 42 of these (31%) did have results posted on ClinicalTrials.gov.
Of the 104 discontinued trials, 39% were sponsored by industry, and 55% were sponsored by academic institutions. (The rest were funded by other sources.)
Two years after trial completion, academia-sponsored trials accounted for 30% of unpublished trials, and industry-sponsored trials accounted for 63%.
Three years after trial completion, academia-sponsored trials accounted for 23% of unpublished trials, and industry-sponsored trials accounted for 70%.
In a multivariate analysis, the likelihood of non-publication was more than doubled for industry-sponsored trials 2 years after completion (odds ratio=2.21) and more than tripled 3 years after completion (odds ratio=3.12).
Overall, more than 8000 children were enrolled in trials that were never completed, and more than 69,000 children were enrolled in completed trials that were never published.
“This is the first study to look systematically at discontinuation and nonpublication of interventional pediatric clinical trials,” Dr Bourgeois said.
“A number of legislative initiatives have been implemented to increase the study of interventions in children. Now, we need to make sure that the proper resources are in place to ensure that information gleaned from these studies reaches the scientific community.”
One proposed initiative cited by Drs Bourgeois and Pica is RIAT (Restoring Invisible and Abandoned Trials), which is supported by some high-profile journals. RIAT invites researchers with unpublished trials to either commit to publish within a year or provide public access to their data.
“It’s hard to reanalyze others’ data,” Dr Pica noted, “but this may be a useful mechanism to make sure that findings from completed trials are disseminated in the medical literature.”
Photo by Logan Tuttle
Clinical trials in children too often go uncompleted or unpublished, according to a pair of researchers.
The duo evaluated nearly 560 pediatric trials and found that 19% were discontinued early. Of the trials that were completed, 30% remained unpublished several years later.
Industry-sponsored trials were more likely to be completed than trials sponsored by academic institutions. However, completed trials sponsored by industry were less likely to be published than trials sponsored by academia.
“Our findings are in line with previously published studies focusing on adult trials, which may speak to how commonplace discontinuation and non-publication are in medical research in general,” said study author Natalie Pica, MD, PhD, of Boston Children’s Hospital in Massachusetts.
She and Florence Bourgeois, MD, also of Boston Children’s Hospital, reported these findings in Pediatrics.
The researchers tracked 559 randomized, controlled pediatric trials registered on ClinicalTrials.gov from 2008 to 2010 and whose final status (completed or discontinued) was confirmed by the end of 2012.
The pair then searched for related peer-reviewed articles published through September 1, 2015. When no publication could be found, the researchers inquired with study investigators and sponsors via email.
Of the 559 trials, 104 (19%) were discontinued early. Two-thirds of these had enrolled participants.
Of the 455 completed trials, 136 (30%) remained unpublished after an average of 58 months post-completion. However, 42 of these (31%) did have results posted on ClinicalTrials.gov.
Of the 104 discontinued trials, 39% were sponsored by industry, and 55% were sponsored by academic institutions. (The rest were funded by other sources.)
Two years after trial completion, academia-sponsored trials accounted for 30% of unpublished trials, and industry-sponsored trials accounted for 63%.
Three years after trial completion, academia-sponsored trials accounted for 23% of unpublished trials, and industry-sponsored trials accounted for 70%.
In a multivariate analysis, the likelihood of non-publication was more than doubled for industry-sponsored trials 2 years after completion (odds ratio=2.21) and more than tripled 3 years after completion (odds ratio=3.12).
Overall, more than 8000 children were enrolled in trials that were never completed, and more than 69,000 children were enrolled in completed trials that were never published.
“This is the first study to look systematically at discontinuation and nonpublication of interventional pediatric clinical trials,” Dr Bourgeois said.
“A number of legislative initiatives have been implemented to increase the study of interventions in children. Now, we need to make sure that the proper resources are in place to ensure that information gleaned from these studies reaches the scientific community.”
One proposed initiative cited by Drs Bourgeois and Pica is RIAT (Restoring Invisible and Abandoned Trials), which is supported by some high-profile journals. RIAT invites researchers with unpublished trials to either commit to publish within a year or provide public access to their data.
“It’s hard to reanalyze others’ data,” Dr Pica noted, “but this may be a useful mechanism to make sure that findings from completed trials are disseminated in the medical literature.”