Article type
Year
Abstract
Background: Children are a unique population with distinct developmental and physiological differences from adults. Clinical trials in children are essential to develop age-specific, empirically-verified therapies and interventions to determine and improve the best medical treatment available.
Objectives: To identify clinical trials in children and survey of their characteristics.
Methods: All records within the WHO International Clinical Trials Registry Platform (WHO ICTRP) were scanned for clinical trials in children. Two reviewers screened the retrieved records for potentially relevant papers and extracted details on type of disease, clinical study categories and fund, and registration year.
Results: Five hundred and seven were included. In view of the limited space, we only focused on four items of WHO Trial Registration Data Set (TRDS). Figure showed that the frequency of clinical trials in children were found to increase over time: from 13 (2.56%) in 1999–2002 to 338 (66.67%) in 2009–2011; 399 (78.70%) trials assessed the effective and safety of health intervention; 192 (37.87) trials were supported by university, 88 (17.36) supported by hospital, 81 (16.00%) were supported by public fund, 58 (14.40%) were supported by manufactory; 120 (23.67%) trials focused on growth and nutritional disorders, follow by respiratory system disease (61:12.03%), digestive system disease (40:7.89%), muscle system disease (36:7.10%), infectious disease (32:6.31%), hematopoietic system disease (32:6.31%).
Conclusions: Registration is one of the means to promote the transparency, openness and justice of research, to improve the quality of trial design, and to raise public trust in research. This investigation shows the number of clinical trials was increased. majority of clinical trials were supported by public organization, which may be reduce the other bias. Therefore, we suggest that future research on assessment of registration quality of trials in children.
Objectives: To identify clinical trials in children and survey of their characteristics.
Methods: All records within the WHO International Clinical Trials Registry Platform (WHO ICTRP) were scanned for clinical trials in children. Two reviewers screened the retrieved records for potentially relevant papers and extracted details on type of disease, clinical study categories and fund, and registration year.
Results: Five hundred and seven were included. In view of the limited space, we only focused on four items of WHO Trial Registration Data Set (TRDS). Figure showed that the frequency of clinical trials in children were found to increase over time: from 13 (2.56%) in 1999–2002 to 338 (66.67%) in 2009–2011; 399 (78.70%) trials assessed the effective and safety of health intervention; 192 (37.87) trials were supported by university, 88 (17.36) supported by hospital, 81 (16.00%) were supported by public fund, 58 (14.40%) were supported by manufactory; 120 (23.67%) trials focused on growth and nutritional disorders, follow by respiratory system disease (61:12.03%), digestive system disease (40:7.89%), muscle system disease (36:7.10%), infectious disease (32:6.31%), hematopoietic system disease (32:6.31%).
Conclusions: Registration is one of the means to promote the transparency, openness and justice of research, to improve the quality of trial design, and to raise public trust in research. This investigation shows the number of clinical trials was increased. majority of clinical trials were supported by public organization, which may be reduce the other bias. Therefore, we suggest that future research on assessment of registration quality of trials in children.
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