Lynn G Dressler1, Allison M Deal2, Kouros Owzar2, Dorothy Watson2, Katherine Donahue2, Paula N Friedman2, Mark J Ratain2, Howard L McLeod2. 1. Personalized Medicine, Mission Cancer Care, Mission Health, Asheville, NC (LGD); Biostatistics Core, Lineberger Comprehensive Cancer Center, School of Medicine, University of North Carolina, Chapel Hill, NC (AMD); Alliance Statistics and Data Center, Duke University, Durham, NC (formerly the Cancer and Leukemia Group B Statistical and Data Management Center, Duke University, Durham, NC) (KO); GlaxoSmithKline, Research Triangle Park, NC (DW); Independent contractor, Williamsville, NY (KD); Department of Medicine and Center for Personalized Therapeutics, University of Chicago, Chicago, IL (PNF, MJR); DeBartolo Family Personalized Medicine Institute, Moffitt Cancer Center, Tampa, FL (HLM). lynn.dressler@msj.org. 2. Personalized Medicine, Mission Cancer Care, Mission Health, Asheville, NC (LGD); Biostatistics Core, Lineberger Comprehensive Cancer Center, School of Medicine, University of North Carolina, Chapel Hill, NC (AMD); Alliance Statistics and Data Center, Duke University, Durham, NC (formerly the Cancer and Leukemia Group B Statistical and Data Management Center, Duke University, Durham, NC) (KO); GlaxoSmithKline, Research Triangle Park, NC (DW); Independent contractor, Williamsville, NY (KD); Department of Medicine and Center for Personalized Therapeutics, University of Chicago, Chicago, IL (PNF, MJR); DeBartolo Family Personalized Medicine Institute, Moffitt Cancer Center, Tampa, FL (HLM).
Abstract
BACKGROUND: Clinically annotated specimens from cancer clinical trial participants offer an opportunity for discovery and validation of pharmacogenomic findings. The purpose of this observational study is to better understand patient/institution factors that may contribute to participation in the pharmacogenomic component of prospective cancer clinical trials. METHODS: Patient demographic information (age, sex, self-reported race) and institutional characteristics (CALGB/CTSU site, "diversity," and accrual) were evaluated for 8456 patients enrolled in seven CALGB phase III studies with a pharmacogenomic component. All statistical tests were two-sided. RESULTS: The majority of patients (81%) consented to participate in the pharmacogenomic component. However, in a multivariable analysis, site (CALGB vs CTSU) and "institutional diversity" (percent minority cancer patients on national trials) were statistically significantly associated with participation. For both whites and nonwhites, patients from CALGB sites were more likely to participate compared with patients from CTSU sites (whites: odds ratio [OR] = 2.26, 95% confidence interval [CI] = 1.68 to 3.04, P < .001; nonwhites: OR = 1.79, 95% CI = 1.52 to 2.11, P < .001). However, as "institutional diversity" increased, the likelihood of participation in the pharmacogenomics component decreased for both white (OR = 0.94, 95% CI = 0.91 to 0.97, P < .001) and nonwhite patients (OR = 0.90, 95% CI = 0.81 to 1.00, P = .05). CONCLUSIONS: Most clinical trial cancer patients across geographical, racial, and practice settings are willing to participate in pharmacogenomic studies. However, to promote equitable benefit to the larger cancer community, optimization of both patient and institutional participation are needed. Institutional factors may be even more compelling than patient demographics. Prospective studies are needed to identify and address barriers/incentives to participation in pharmacogenomic research at the patient, clinician, and institutional levels.
BACKGROUND: Clinically annotated specimens from cancer clinical trial participants offer an opportunity for discovery and validation of pharmacogenomic findings. The purpose of this observational study is to better understand patient/institution factors that may contribute to participation in the pharmacogenomic component of prospective cancer clinical trials. METHODS:Patient demographic information (age, sex, self-reported race) and institutional characteristics (CALGB/CTSU site, "diversity," and accrual) were evaluated for 8456 patients enrolled in seven CALGB phase III studies with a pharmacogenomic component. All statistical tests were two-sided. RESULTS: The majority of patients (81%) consented to participate in the pharmacogenomic component. However, in a multivariable analysis, site (CALGB vs CTSU) and "institutional diversity" (percent minority cancerpatients on national trials) were statistically significantly associated with participation. For both whites and nonwhites, patients from CALGB sites were more likely to participate compared with patients from CTSU sites (whites: odds ratio [OR] = 2.26, 95% confidence interval [CI] = 1.68 to 3.04, P < .001; nonwhites: OR = 1.79, 95% CI = 1.52 to 2.11, P < .001). However, as "institutional diversity" increased, the likelihood of participation in the pharmacogenomics component decreased for both white (OR = 0.94, 95% CI = 0.91 to 0.97, P < .001) and nonwhite patients (OR = 0.90, 95% CI = 0.81 to 1.00, P = .05). CONCLUSIONS: Most clinical trial cancerpatients across geographical, racial, and practice settings are willing to participate in pharmacogenomic studies. However, to promote equitable benefit to the larger cancer community, optimization of both patient and institutional participation are needed. Institutional factors may be even more compelling than patient demographics. Prospective studies are needed to identify and address barriers/incentives to participation in pharmacogenomic research at the patient, clinician, and institutional levels.
Authors: Laura M Beskow; Jeffrey R Botkin; Mary Daly; Eric T Juengst; Lisa Soleymani Lehmann; Jon F Merz; Rebecca Pentz; Nancy A Press; Lainie Friedman Ross; Jeremy Sugarman; Lisa R Susswein; Sharon F Terry; Melissa A Austin; Wylie Burke Journal: Am J Med Genet A Date: 2004-11-01 Impact factor: 2.802
Authors: William R Carpenter; Paul A Godley; Jack A Clark; James A Talcott; Timothy Finnegan; Merle Mishel; Jeannette Bensen; Walter Rayford; L Joseph Su; Elizabeth T H Fontham; James L Mohler Journal: Cancer Date: 2009-11-01 Impact factor: 6.860
Authors: Electra D Paskett; Katherine W Reeves; John M McLaughlin; Mira L Katz; Ann Scheck McAlearney; Mack T Ruffin; Chanita Hughes Halbert; Cristina Merete; Faith Davis; Sarah Gehlert Journal: Contemp Clin Trials Date: 2008-07-31 Impact factor: 2.226
Authors: Elise D Cook; Katherine A Yeager; Reena S Cecchini; Jaskaran Boparai; Carol L Brown; Martha Duncan; Walter M Cronin; Electra D Paskett Journal: Contemp Clin Trials Commun Date: 2018-03-09