Status of the Pediatric Clinical Trials Enterprise: An Analysis of the US ClinicalTrials.gov Registry

Pasquali, Sara K.; Lam, Wendy; Chiswell, Karen; Kemper, Alex R.; Li, Jennifer S.

doi:10.1542/peds.2011-3565

Cited by 86 publications

(88 citation statements)

References 19 publications

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“…These results are consistent with other studies that have examined the characteristics of clinical studies for a wide range of medical conditions and surgical procedures. [11][12][13][14][15][16] Recent evidence indicates that studies funded by industry sources are unlikely to publish reports not favoring the funding entities or negative results. 6,7 Consequently, there could be a potential for publication bias.…”

Section: Discussionmentioning

confidence: 99%

“…Although several studies have examined the characteristics of registered studies for a wide variety of medical conditions, to our knowledge, no study to date has documented the characteristics of clinical studies in orthodontics that are registered in ClinicalTrials.gov. [11][12][13][14][15][16] Such reports will enable us to understand the areas of clinical interest that are the focus of orthodontic clinical studies, study designs, funding sources, and outcome measurements. The objective of our study was to examine the characteristics of registered orthodontic clinical studies.…”

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confidence: 99%

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Overview of registered studies in orthodontics: Evaluation of the ClinicalTrials.gov registry

Allareddy

Rampa

Masoud

et al. 2014

American Journal of Orthodontics and Dentofacial Orthopedics

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Section: Discussionmentioning

confidence: 99%

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confidence: 99%

Overview of registered studies in orthodontics: Evaluation of the ClinicalTrials.gov registry

Allareddy

Rampa

Masoud

et al. 2014

American Journal of Orthodontics and Dentofacial Orthopedics

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“…Similar to prior ClinicalTrials.gov analyses in adults and in the broader subset of pediatric trials, 11, 17 most PCVTs are smaller trials and a majority are not funded by either industry or NIH. Perhaps most concerning, however, is that the number of registered pediatric cardiovascular trials is relatively low - substantially smaller than the number of adult cardiovascular trials and also smaller than for other pediatric sub-specialties.…”

Section: Discussionmentioning

confidence: 80%

“…7–9 This has sparked recent debate regarding whether the pediatric clinical trial landscape appropriately represents the burden of pediatric disease. 10, 11 …”

Section: Introductionmentioning

confidence: 99%

Characteristics of pediatric cardiovascular clinical trials registered on ClinicalTrials.gov

Hill

Chiswell

Califf

et al. 2014

American Heart Journal

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Background ClinicalTrials.gov is an NIH-sponsored registry of federally and privately funded trials. We sought to determine fundamental characteristics of registered pediatric cardiovascular trials (PCVTs). Methods A data set including 68134 interventional clinical trials was downloaded from ClinicalTrials.gov and entered into a relational database. Aggregate data from PCVTs were compared with other trial specialties. Multivariable logistic regression was used to evaluate factors associated with improved trial quality metrics including blinding and randomization. Results Between 7/01/2005 and 9/27/2010, 5035 (7%) registered trials targeted pediatric populations, including 213 PCVTs (4.2%), 1176 pediatric infectious disease trials (23%), 664 pediatric mental health trials (13%) and 346 pediatric hematology/oncology trials (7%). Median (IQR) PCVT enrollment was 65 subjects (36–186) and median study duration was 2.3 years (1.3–3.7). The most common PCVTs targeted acquired diseases including hypertension (n=41, 14%), obesity (n=26, 9%), pulmonary hypertension (n=25, 9%) and dyslipidemia (n=19, 7%). Important factors associated with improved quality metrics included: NIH as opposed to industry funding (OR=1.9, p<0.0001); trial location (trials with both U.S.and foreign enrollment vs. trials with US only or foreign only enrollment, p=0.02) and trials restricted to younger children as opposed to trials including adolescents (OR=1.4, p<0.0001). Conclusion PCVTs represent a small proportion of clinical trials relative to other pediatric sub-specialties. Most PCVTs tend to parallel adult morbidities while there is a relative paucity of trials focused on congenital heart disease. These data may be useful to stakeholders in informing decisions regarding the conduct of PCVTs, and to provide insight into mechanisms to advance PCVT infrastructure.

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“…Recent reviews of ClinicalTrials.gov have evaluated trends, characteristics, and status of research for various specialties [15], [16], [17], conditions of interest [18], [19], [20], and age groups [21], [22], [23]. No similar published reviews related to military-relevant biomedical research or research involving U.S. military service members have been identified.…”

Section: Introductionmentioning

confidence: 99%

Trends in research with U.S. military service member participants: A population-specific ClinicalTrials.gov review

Cook

Doorenbos

Bridges

2016

Contemporary Clinical Trials Communications

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Background ClinicalTrials.gov reviews have evaluated research trends for specific conditions and age groups but not for specific populations of research participants. No ClinicalTrials.gov reviews have evaluated research with military service member participants. Purpose Study objectives were (a) to use ClinicalTrials.gov to identify trends in biomedical research from 2005 to 2014 in which U.S. military service members actively participated as research participants and (b) to describe a search strategy for adaptation in future ClinicalTrials.gov reviews of specific participant populations. Methods A systematic review of ClinicalTrials.gov was performed to identify studies that included U.S. service members as participants, either exclusively or with other groups of participants. Results U.S. service members were identified as participants in 512 studies. Service members participated together with other groups in 392 studies, while 120 studies included only service members. The top five conditions of interest were post-traumatic stress disorder, traumatic brain injury, amputations, burns, and ocular injuries/disorders. The number of studies started each year peaked in 2011 and declined from 2012 to 2014. Twenty-five percent of studies exclusive to service members aimed to enroll 500 or more participants. Research exclusive to Guard and Reserve service members during this period was limited. Conclusions U.S. military service members participate in biomedical research. To address the health needs of U.S. service members, it is important to ensure there is not a prolonged decline in research among this population. The search strategy may be adapted to ClinicalTrials.gov reviews of specific participant populations for which straightforward searches are not possible.

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Status of the Pediatric Clinical Trials Enterprise: An Analysis of the US ClinicalTrials.gov Registry

Cited by 86 publications

References 19 publications

Overview of registered studies in orthodontics: Evaluation of the ClinicalTrials.gov registry

Overview of registered studies in orthodontics: Evaluation of the ClinicalTrials.gov registry

Characteristics of pediatric cardiovascular clinical trials registered on ClinicalTrials.gov

Trends in research with U.S. military service member participants: A population-specific ClinicalTrials.gov review

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