Presentations

Abstract

Background:

Clinical trials have been instrumental to the rapid improvement in pediatric cancer outcomes in past decades. Nonetheless, pediatric cancer outcomes are significantly worse in low- and middle-income countries (LMICs), where most of the world's pediatric cancer patients reside. Due to the importance of clinical trials in pediatric cancer care, we sought to evaluate the landscape of clinical research globally.

Methods:

Clinical studies registered in two public trial registries, ClinicalTrials.gov (CTG) and the International Clinical Trials Registry Platform (ICTRP), were screened based on the following inclusion criteria: that participants were pediatric patients (≤17 years old) diagnosed with cancer. PubMed was used to perform a literature review to identify published results. Fisher's exact test and χ2 tests were done to compare frequencies across groups.

Results:

The search identified 112,399 publications. A total of 637 studies met inclusion criteria. Most studies (470, 74%) were conducted in high income countries (HICs), while 167 (26%) studies were in middle- income countries, and no studies were registered in low-income countries. Study characteristics differed significantly among country income status, with HICs registering mostly early phase clinical trials focusing on cancer-directed treatment and LMICs registering later phase supportive care-based trials (p<0.001). Most patient accrual occurred in HICs. Further, more multi-institutional, multi-national patient accrual and collaboration occurred between HICs. Of the studies registered, 101 were published. Studies in HICs were more likely to be published (p<0.001). However, there was no difference found in time between study and publication (p=0.20).

Conclusion:

Globally, LMICs are under-represented in the clinical research landscape. Most clinical studies in LMICs tend to be concentrated to a few countries and tend to be less complex and employ less rigorous interventions. These data describe the urgent needs to invest in clinical research infrastructure in LMICs and foster collaborations that include LMICs as critical steps in achieving equity in global pediatric cancer outcomes.