TY - JOUR
T1 - Barriers to non-small cell lung cancer trial eligibility
AU - Hardesty, Jeffrey J.
AU - Kanarek, Norma F.
N1 - Funding Information:
We thank Dina Lansey, MSN, RN, OCN and Dr. Michael Carducci, MD, Johns Hopkins School of Medicine, for their helpful advice on the study concept and design. Additionally, we thank Johns Hopkins Bloomberg School of Public Health, Johns Hopkins School of Medicine, and Sidney Kimmel Comprehensive Cancer Center for their support of this research.
Funding Information:
This work was supported in part by the Maryland Cigarette Restitution Fund at Johns Hopkins Sidney Kimmel Comprehensive Cancer Center Support Grant from the National Cancer Institute ( P30 CA006973 ), and the Medical Students Training in Aging Research Program ( T35AG026758 ). Funders did not influence study design, data collection, analysis, interpretation of data, writing of the manuscript, or the decision to submit for publication.
Publisher Copyright:
© 2017
PY - 2018/3
Y1 - 2018/3
N2 - Introduction Cancer clinical trial (CCT) enrollment is low potentially threatening the generalizability of trial results and expedited regulatory approvals. We assessed whether type of initial patient appointment for non-small cell lung cancer (NSCLC) is associated with CCT eligibility. Methods Using a patient-to-accrual framework, we conducted a quasi-retrospective cohort pilot study at Sidney Kimmel Comprehensive Cancer Center (SKCCC), Baltimore, Maryland. 153 NSCLC patients new to SKCCC were categorized based on type of initial appointment: patients diagnosed or treated and patients seen for a consultation. CCT eligibility was determined by comparing eligibility criteria for each open trial to the electronic medical record (EMR) of each patient at every office visit occurring within 6-months of initial visit. Results We found no association between type of initial appointment and CCT eligibility (OR, 1.15; 95% CI, 0.49–2.73). Analyses did suggest current smokers were less likely to be eligible for trials compared to never smokers (OR, 0.15; 95% CI, 0.03–0.64), and stage 4 patients with second line therapy or greater were more likely to be eligible than stage 1 or 2 patients (OR, 5.18; 95% CI, 1.08–24.75). Additional analyses suggested most current smokers and stage 1 or 2 patients had trials available but were still ineligible. Conclusions SKCCC has a diverse portfolio of trials available for NSCLC patients and should consider research strategies to re-examine eligibility criteria for future trials to ensure increased enrollment of current smokers and stage 1 or 2 patients. We could not confirm whether type of initial visit was related to eligibility.
AB - Introduction Cancer clinical trial (CCT) enrollment is low potentially threatening the generalizability of trial results and expedited regulatory approvals. We assessed whether type of initial patient appointment for non-small cell lung cancer (NSCLC) is associated with CCT eligibility. Methods Using a patient-to-accrual framework, we conducted a quasi-retrospective cohort pilot study at Sidney Kimmel Comprehensive Cancer Center (SKCCC), Baltimore, Maryland. 153 NSCLC patients new to SKCCC were categorized based on type of initial appointment: patients diagnosed or treated and patients seen for a consultation. CCT eligibility was determined by comparing eligibility criteria for each open trial to the electronic medical record (EMR) of each patient at every office visit occurring within 6-months of initial visit. Results We found no association between type of initial appointment and CCT eligibility (OR, 1.15; 95% CI, 0.49–2.73). Analyses did suggest current smokers were less likely to be eligible for trials compared to never smokers (OR, 0.15; 95% CI, 0.03–0.64), and stage 4 patients with second line therapy or greater were more likely to be eligible than stage 1 or 2 patients (OR, 5.18; 95% CI, 1.08–24.75). Additional analyses suggested most current smokers and stage 1 or 2 patients had trials available but were still ineligible. Conclusions SKCCC has a diverse portfolio of trials available for NSCLC patients and should consider research strategies to re-examine eligibility criteria for future trials to ensure increased enrollment of current smokers and stage 1 or 2 patients. We could not confirm whether type of initial visit was related to eligibility.
KW - Barriers
KW - Eligibility
KW - Lung cancer
KW - Trials
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U2 - 10.1016/j.conctc.2017.11.010
DO - 10.1016/j.conctc.2017.11.010
M3 - Article
C2 - 29696224
AN - SCOPUS:85037652428
SN - 2451-8654
VL - 9
SP - 45
EP - 49
JO - Contemporary Clinical Trials Communications
JF - Contemporary Clinical Trials Communications
ER -