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Access to Children's Oncology Group and Pediatric Brain Tumor Consortium phase 1 clinical trials: Racial/ethnic dissimilarities in participation
Author(s) -
Nooka Ajay K.,
Behera Madhusmita,
Lonial Sagar,
Dixon Margie D.,
Ramalingam Suresh S.,
Pentz Rebecca D.
Publication year - 2016
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.30090
Subject(s) - medicine , ethnic group , clinical trial , clinical oncology , oncology , pediatric oncology , family medicine , cancer , sociology , anthropology
BACKGROUND Phase 1 clinical trials introduce new therapies to humans with the goal of establishing their safety. A prior Children's Oncology Group (COG) study analyzed the proportional enrollment of patients by race, ethnicity, sex, and age for all trial phases. The current study evaluated the representation of patients by race, ethnicity, sex, and age in phase 1 clinical trials. METHODS This study evaluated 1348 children with 128 diagnoses enrolled in COG and Pediatric Brain Tumor Consortium phase 1 clinical trials in the United States from February 28, 2000 to December 29, 2008. Observed and expected proportions were calculated according to an established methodology with a representative population from Surveillance, Epidemiology, and End Results data, which included 27,766 children with the same International Classification of Diseases for Oncology (third edition) diagnostic codes. RESULTS Underrepresentation in phase 1 trials was seen for lymphohematopoietic (LH) tumors (9.3% observed vs 37% expected) versus solid tumors (90.6% observed vs 63% expected). Although representation was fairly proportional, Hispanics (12.6% observed vs 27% expected), particularly Hispanic females (6% observed vs 18% expected), were significantly underrepresented. The 0‐ to 4‐year age group was underrepresented (11.7% observed vs 36.5% expected). By tumor type, the most significantly underrepresented groups were 0‐ to 4‐year‐old children and Hispanics for both solid cancers (11% observed vs 34.4% expected for 0‐ to 4‐year‐old children and 12% observed vs 24% expected for Hispanics) and LH cancers (16% observed vs 40% expected for 0‐ to 4‐year‐old children and 19.4% observed vs 33% expected for Hispanics). CONCLUSIONS Although sex and racial/ethnic groups are mostly proportionally represented in phase 1 trials, some specific subgroups such as Hispanic children are underrepresented and may benefit from focused accrual. Cancer 2016;122:3207–14. © 2016 American Cancer Society .