Institutional Review of Pediatric Oncology Patients Participating in Early Phase Clinical Trials at Dana-Farber
Mentor Name: Steve DuBois
Approximately 390,000 children and adolescents around the world are diagnosed with cancer annually, with 150,000 of these reported in North America. Clinical trials remain the backbone for the evaluation and advancement of novel treatments for patients. These therapies are needed to continue to improve both short-term and long-term outcomes for children with cancer.
Clinical trial participation has resulted in higher survival rates for patients with pediatric cancer. However, a search of the US National Library of Medicine reveals over 2,000 open phase 1 trials for adult cancer patients while less than 200 for pediatric cancer patients. Further, prior studies have demonstrated that cancer clinical trials have insufficient participants from underrepresented and/or low-income backgrounds. Thus, the goal of our study is to determine the demographics of pediatric cancer patients enrolling in early phase clinical trials and their clinical outcomes by analyzing a 10-year period of enrollment at the Dana-Farber Cancer Institute. Moreover, by examining the demographics of clinical trial enrollees, this study will also explore if clinical trial recruitment and design should be modified to increase representation and promote better health outcomes for all pediatric patients.
The results from this study may illuminate how recruitment and design of clinical trials can be amended to promote better health outcomes for pediatric patients who are eligible for phase 1 clinical trials. Survival rates for pediatric cancer have improved significantly over the past five decades, mainly due to clinical trial participation. However, if the data suggest certain groups are underrepresented in early phase clinical trials, the approach for the recruitment for trials can be modified. Further, if differences in clinical outcomes based on the type of treatment option are identified, the method for clinical trial design can be adapted. Thus, insights from this study can be used to inform recruitment strategies and treatment options for clinical trials for pediatric patients with cancer.
