Date of Award

2020

Document Type

Dissertation

Degree Name

Doctor of Philosophy (PhD)

College

College of Nursing

First Advisor

Teresa Kelechi

Second Advisor

Martina Mueller

Third Advisor

Kathleen Cartmell

Abstract

Purpose: The purpose of this dissertation is to explore factors affecting accrual and completion of pediatric oncology clinical trials. This dissertation includes a scoping review of barriers and facilitators to enrollment in pediatric oncology clinical trials, a systematic review of trial-level factors affecting accrual and completion of oncology clinical trials, and an exploratory analysis of trial-level factors affecting accrual and completion of pediatric oncology clinical trials from ClinicalTrials.gov data. Problem/Aims: Cancer is the second leading cause of death in children. Clinical trials explore potential new therapies for children with cancer by determining safety and effectiveness of interventions. The literature demonstrates widespread inadequate accrual of trial participants and associated early termination of oncology clinical trials. This dissertation aimed to provide evidence of trial-level factors affecting accrual and completion of pediatric oncology clinical trials by reviewing the literature, identifying possible trial-level factors, and performing an exploratory analysis of the ClinicalTrials.gov dataset. Design including theoretical basis: A modified version of the Social Ecological Model and Arskey and O’Malley’s framework guided the scoping review. Bennette et al.’s framework, along with that of Knafl and Whittmore, directed the systematic review. Bennette et al.’s framework also guided the exploratory analysis using the ClinicalTrials.gov dataset. Findings: Barriers to enrollment in pediatric oncology clinical trials exist at the trial, individual, interpersonal and organizational levels. Several trial-level barriers to enrollment in adult oncology clinical trials previously were identified, such as enrollment, intervention type, phase, allocation, arm type, sponsor, number of participating facilities, and primary disease. The exploratory analysis indicated none of the aforementioned variables and others such as primary purpose, number of primary outcomes, interventional study model, and number of arms were predictive of early termination of pediatric oncology trials due to low accrual. However, odds for studies to terminate early were 4.7 times higher for those that used a data and safety monitoring committee compared to those that did not (p = 0.05). Conclusion: Findings from the scoping and systematic reviews suggest there are trial-level factors that affect early termination of pediatric oncology trials due to low accrual. Findings from the exploratory study indicated that use of a data and safety monitoring committee plays an important role in early trial termination due to low accrual. The design of future pediatric oncology clinical trials should incorporate approaches to minimize trial-level factors that are associated with or predictive of early trial termination. Additional studies examining trial-level factors should utilize multiple trial databases and investigate pediatric oncology trials that have been conducted worldwide.

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