Examination of reporting status of pediatric oncology trials within the national library of medicine's trial database
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Carly Stewart1, Kristen McPherson1, Liza-Ann Whitaker1
1Office of Medical Student Research at Cherokee Nation, Oklahoma State University Center for Health Sciences, Tahlequah, Oklahoma, USA.
Abstract:
Finding safer and more effective treatment options are critical in progressing the field of pediatric oncology. These treatment options are discovered through completion and publication of clinical trials. The primary objective of this study was to assess the overall study characteristics of pediatric oncology clinical trials initiated between 2008 and 2021. The secondary objective of our study was to assess rates of discontinuation and reporting of results as required by the Food and Drug Administration (FDA). After acquiring pediatric oncology clinical trials from ClinicalTrials.gov, a cross-sectional study was performed. Included trials have an intervention exclusive to pediatrics and were conducted between 2008 and 2021. The results measured were characteristics of the clinical trials and their rate of discontinuation. Of the 7,930 trials originally returned from the search, 349 trials met inclusion criteria. The majority of the trials were phase 1 and 2 pharmaceutical interventions studying brain and blood cancer. Our study found that 14.9% (52) of the pediatric oncology trials were discontinued. Given the breadth of study within pediatric oncology, our overarching assessment shows that drug trials geared toward treating cancers of the brain and blood were dominant in the field. It is crucial for the advancement of science that results of trials are known. This avoids duplication of studies and waste of funds. Of the trials that were completed, 40.3% (58) did not report results to ClinicalTrials.gov. The nonreporting of this data limits the information available delaying the advancement of treatment options.
Insights
Pediatric oncology clinical trials show a high discontinuation rate and a significant lack of results reporting. This hinders the development of new cancer treatments for children.
Area of Science:
- Pediatric Oncology
- Clinical Trials
- Cancer Research
Background:
- Advancing pediatric oncology requires safer, more effective treatments discovered through clinical trials.
- Publication of trial results is crucial for scientific progress and avoiding redundant research.
Purpose of the Study:
- To assess the characteristics of pediatric oncology clinical trials initiated between 2008 and 2021.
- To evaluate trial discontinuation rates and Food and Drug Administration (FDA)-required results reporting.
Main Methods:
- A cross-sectional study analyzed pediatric oncology clinical trials from ClinicalTrials.gov (2008-2021).
- Inclusion criteria focused on interventions exclusive to pediatrics.
- Data collected included trial characteristics, discontinuation rates, and results reporting.
Main Results:
- Out of 7,930 trials, 349 met inclusion criteria; most were Phase 1/2 pharmaceutical interventions for brain and blood cancers.
- 14.9% of pediatric oncology trials were discontinued.
- 40.3% of completed trials failed to report results to ClinicalTrials.gov.
Conclusions:
- Drug trials for pediatric brain and blood cancers dominated the study period.
- High discontinuation and non-reporting rates impede scientific advancement and treatment development.
- Ensuring trial results are reported is vital for efficient research and improved pediatric cancer care.
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