title: Minority participation in Gynecologic Oncology Group (GOG) Studies.
abstract: OBJECTIVE
  Participation of minority populations in clinical trials is paramount to understanding and overcoming cancer racial disparities. The goal of this project is to evaluate minority participation in published GOG clinical trials.
  
  
  METHODS
  GOG publications from 1985 to 2013 were reviewed. Minority enrollment was stratified by tumor site, type of study, and year published. Based on Centers of Disease Control and Prevention (CDC) age-adjusted incidence for race, expected and observed ratios of racial participation were calculated.
  
  
  RESULTS
  A total of 445 GOG publications involving 67,568 patients were reviewed. Racial breakdown was provided in 170 studies (38%) for a total of 45,259 patients: 83% White (n=37,617); 8% Black (n=3,686), and 9% Other (n=3,956). The majority of studies were Ovarian (n=202) and Phase 2 (n=290). When evaluating the quartiles of publication year, a steady decline in the proportion of Black patients enrolled was seen. Race was not reported in any publication prior to 1994. Compared to years 1994-2002, a 2.8-fold lower proportion of black enrollment was noted in years 2009-2013 (16% and 5.8%, respectively; p<0.01). Utilizing CDC age-adjusted incidence, observed enrollment of Black patients onto GOG clinical trials was significantly less than expected enrollment. Observed Black enrollment was 15-fold lower than expected for ovarian trials, 10-fold lower for endometrial, 4.5-fold for cervix, and 5.2-fold for sarcoma (each p<0.001).
  
  
  CONCLUSIONS
  Based on age-adjusted incidence, observed enrollment of Black patients was lower than expected enrollment onto GOG studies. Despite national emphasis on minority enrollment on clinical trials, fewer Black patients were enrolled over time.
authors.affiliation: University of South Alabama Mitchell Cancer Institute, Mobile, AL, USA.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Scalici
authors.affiliation: University of South Alabama Mitchell Cancer Institute, Mobile, AL, USA.
authors.forename: Michael A
authors.initials: MA
authors.lastname: Finan
authors.affiliation: University of South Alabama Mitchell Cancer Institute, Mobile, AL, USA.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Black
authors.affiliation: University of South Alabama Mitchell Cancer Institute, Mobile, AL, USA.
authors.forename: Mary Danner
authors.initials: MD
authors.lastname: Harmon
authors.affiliation: University of South Alabama Mitchell Cancer Institute, Mobile, AL, USA.
authors.forename: William
authors.initials: W
authors.lastname: Nicolson
authors.affiliation: NRG Oncology/Gynecologic Oncology Group, Buffalo, NY, USA.
authors.forename: Heather A
authors.initials: HA
authors.lastname: Lankes
authors.affiliation: NRG Oncology/Gynecologic Oncology Group, Buffalo, NY, USA.
authors.forename: William E
authors.initials: WE
authors.lastname: Brady
authors.affiliation: University of South Alabama Mitchell Cancer Institute, Mobile, AL, USA. Electronic address: rocconi@health.southalabama.edu.
authors.forename: Rodney P
authors.initials: RP
authors.lastname: Rocconi
mesh_terms: D001741:Black or African American / Q000706:statistics & numerical data*; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D017322:Clinical Trials, Phase II as Topic / Q000706:statistics & numerical data; D005260:Female; D005833:Genital Neoplasms, Female / Q000453:epidemiology / Q000208:ethnology* / Q000628:therapy*; D054625:Healthcare Disparities / Q000706:statistics & numerical data*; D006801:Humans; D010051:Ovarian Neoplasms / Q000453:epidemiology / Q000208:ethnology / Q000628:therapy; D014481:United States / Q000453:epidemiology
keywords: Clinical trials; Gynecologic malignancies; Racial healthcare disparity