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Accrual Trends for Children's Oncology Group Clinical Trials: A Single Center Experience
Bailey Anderson1, Ian Wolfe, Ashwath Muruganand
1Department of Pediatric Hematology/Oncology, University of Michigan, Ann Arbor, MI.
Abstract:
Children's Oncology Group (COG) has been highly successful in improving childhood cancer survival through well-designed multi-institutional clinical trials. However, our center has recognized a decline in the number of enrollments on COG therapeutic clinical trials over recent years. Our single center, retrospective analysis evaluated in detail the patient enrollment rates, annual number of available clinical trials and reason for nonenrollment over the last decade. We found a 61% decrease in enrollment for phase II to III trials of newly diagnosed patients at our center (2011-2018) along a 29% decrease in the number of open COG studies annually. The primary reason for nonenrollment was unavailability of a suitable trial (76%). We also recognized a decrease in number of adolescent and young adult enrollment particularly in the last 8 years (2010-2018); however, the enrollment rate for adolescent and young adults was not substantially different than enrollment of children. The reasons for reduced enrollments are most likely multifactorial and complex. It is imperative that we continue to develop novel clinical studies using a portfolio of federal, investigator-initiated, and industry trials for pediatric oncology patients to continue to advance outcomes, study survivorship, and improve quality of life for these patients.
Insights
Enrollment in Children's Oncology Group (COG) therapeutic trials has declined significantly, with most pediatric cancer patients unable to find suitable studies. This trend necessitates developing new clinical trials to improve outcomes.
Area of Science:
- Pediatric Oncology
- Clinical Trials
- Cancer Research
Background:
- Children's Oncology Group (COG) has historically improved childhood cancer survival.
- A recent decline in COG therapeutic clinical trial enrollment has been observed at our center.
Purpose of the Study:
- To analyze patient enrollment rates, available clinical trials, and nonenrollment reasons over the past decade.
- To investigate trends in adolescent and young adult enrollment in pediatric oncology trials.
Main Methods:
- Single-center, retrospective analysis of patient enrollment data from 2011-2018.
- Evaluation of annual number of available COG studies and reasons for nonenrollment.
Main Results:
- A 61% decrease in enrollment for phase II-III trials in newly diagnosed patients.
- A 29% annual decrease in the number of open COG studies.
- The primary reason for nonenrollment was the unavailability of a suitable trial (76%).
- A decrease in adolescent and young adult enrollment was noted, though rates were similar to children.
Conclusions:
- Reduced enrollment in pediatric oncology clinical trials is multifactorial.
- There is an urgent need for diverse clinical trial portfolios (federal, investigator-initiated, industry) to advance pediatric cancer care, survivorship, and quality of life.
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