title: Temporal Trends and Predictors for Cancer Clinical Trial Availability for Medically Underserved Populations.
abstract: BACKGROUND
  Lack of access to available cancer clinical trials has been cited as a key factor limiting trial accrual, particularly among medically underserved populations. We examined the trends and factors in clinical trial availability within a major U.S. safety-net hospital system.
  
  
  METHODS
  We identified cancer clinical trials activated at the Harold C. Simmons Cancer from 1991 to 2014 and recorded the characteristics of the trials that were and were not activated at the Parkland Health and Hospital System satellite site. We used univariate and multivariate logistic regression to determine the association between trial characteristics and nonactivation status, and chi-square analysis to determine the association between the trial characteristics and the reasons for nonactivation.
  
  
  RESULTS
  A total of 773 trials were identified, of which 152 (20%) were not activated at Parkland. In multivariable analysis, nonactivation at Parkland was associated with trial year, sponsor, and phase. Compared with the 1991-2006 period, clinical trials in the 2007-2014 period were almost eightfold more likely not to be activated at Parkland. The most common reasons for nonactivation at Parkland were an inability to perform the study procedures (27%) and the startup costs (15%).
  
  
  CONCLUSIONS
  Over time, in this single-center setting, a decreasing proportion of cancer clinical trials were available to underserved populations. Trial complexity and costs appeared to account for much of this trend. Efforts to overcome these barriers will be key to equitable access to clinical trials, efficient accrual, and the generalizability of the results.
  
  
  CONCLUSIONS
  Despite numerous calls to increase and diversify cancer clinical trial accrual, the present study found that cancer clinical trial activation rates in a safety-net setting for medically underserved populations have decreased substantially in recent years. The principal reasons for study nonactivation were expenses and an inability to perform the study-related procedures, reflecting the increasing costs and complexity of cancer clinical trials. Future efforts need to focus on strategies to mitigate the increasing disparity in access to clinical research and cutting-edge therapies, which also threatens to hinder study accrual, completion rates, and generalizability.
authors.affiliation: Division of Hematology-Oncology, Department of Internal Medicine, Department of Cell Biology, Division of Biostatistics, Department of Clinical Sciences, and Harold C. Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, Texas, USA; Oncology Clinic, Parkland Health and Hospital System, Dallas, Texas, USA david.gerber@utsouthwestern.edu.
authors.forename: David E
authors.initials: DE
authors.lastname: Gerber
authors.affiliation: Division of Hematology-Oncology, Department of Internal Medicine, Department of Cell Biology, Division of Biostatistics, Department of Clinical Sciences, and Harold C. Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, Texas, USA; Oncology Clinic, Parkland Health and Hospital System, Dallas, Texas, USA.
authors.forename: Ashley M
authors.initials: AM
authors.lastname: Lakoduk
authors.affiliation: Division of Hematology-Oncology, Department of Internal Medicine, Department of Cell Biology, Division of Biostatistics, Department of Clinical Sciences, and Harold C. Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, Texas, USA; Oncology Clinic, Parkland Health and Hospital System, Dallas, Texas, USA.
authors.forename: Laurin L
authors.initials: LL
authors.lastname: Priddy
authors.affiliation: Division of Hematology-Oncology, Department of Internal Medicine, Department of Cell Biology, Division of Biostatistics, Department of Clinical Sciences, and Harold C. Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, Texas, USA; Oncology Clinic, Parkland Health and Hospital System, Dallas, Texas, USA.
authors.forename: Jingsheng
authors.initials: J
authors.lastname: Yan
authors.affiliation: Division of Hematology-Oncology, Department of Internal Medicine, Department of Cell Biology, Division of Biostatistics, Department of Clinical Sciences, and Harold C. Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, Texas, USA; Oncology Clinic, Parkland Health and Hospital System, Dallas, Texas, USA.
authors.forename: Xian-Jin
authors.initials: XJ
authors.lastname: Xie
mesh_terms: D002986:Clinical Trials as Topic; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy / Q000453:epidemiology* / Q000473:pathology; D014481:United States; D035862:Vulnerable Populations
keywords: Accrual; Cancer; Clinical trials; Underrepresented minorities; Underserved populations