Grant Number:	5R03CA191875-02 Interpret this number
Primary Investigator:	Gerber, David
Organization:	Ut Southwestern Medical Center
Project Title:	Evaluating Prior Cancer Exclusion Policy to Increase Lung Cancer Trial Accrual
Fiscal Year:	2016

¿ DESCRIPTION (provided by applicant): Despite intensive efforts to increase participation in cancer clinical trials, fewer than two percent of US adults are enrolled in clinical trials. Over 4% of National Cancer Institute-sponsored cooperative group trials fail to complete accrual. Clinical trial eligibility criteria present one of the most significant barriers to study accrual and one ofthe few accrual factors directly controlled by investigators and sponsors. Over time, these criteria have become more numerous and restrictive. Across cancer types, a history of prior cancer is a widespread exclusion criterion in clinical trials. This common practice reflects concerns that a prior cancer diagnosis could interfere with study conduct or outcomes, but there are no data clearly supporting these assumptions. Because this practice hinders accrual, limits generalizability of findings, and discriminates against cancer survivors, we need to understand its basis and implications. In a preliminary analysis, we found that approximately 80% of industry- and government-sponsored lung cancer trials exclude patients with prior cancer. For some trials, we projected that over 18% of lung cancer patients would be excluded for this reason alone, corresponding to more than 200 excluded patients for some large phase 3 trials. The goal of the proposed study is to determine the prevalence and impact of prior cancer among older patients with lung cancer using a large, representative, population-based US dataset. Given the large and growing number of cancer survivors, this research will have important and immediate impact on lung cancer clinical trial design and conduct. For example, if we document equivalent or better survival for those with prior cancer, investigators and sponsors could change or modify this exclusion criterion. In turn, this will increase study accrual and completion rates, resulting in getting better treatments to more patients sooner.




QTc Interval-Prolonging Medications Among Patients With Lung Cancer: Implications for Clinical Trial Eligibility and Clinical Care.
Authors: Le T. , Yang H. , Rashdan S. , Link M.S. , Zaha V.G. , Alvarez C. , Gerber D.E. .
Source: Clinical Lung Cancer, 2020 Jan; 21(1), p. 21-27.e5.
EPub date: 2019-11-25 00:00:00.0.
PMID: 31780402
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Estimating lead-time bias in lung cancer diagnosis of patients with previous cancers.
Authors: Ge Z. , Heitjan D.F. , Gerber D.E. , Xuan L. , Pruitt S.L. .
Source: Statistics In Medicine, 2018-07-20 00:00:00.0; 37(16), p. 2516-2529.
EPub date: 2018-04-23 00:00:00.0.
PMID: 29687467
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Prevalence of Prior Cancer Among Persons Newly Diagnosed With Cancer: An Initial Report From the Surveillance, Epidemiology, and End Results Program.
Authors: Murphy C.C. , Gerber D.E. , Pruitt S.L. .
Source: Jama Oncology, 2018-06-01 00:00:00.0; 4(6), p. 832-836.
PMID: 29167866
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How does autoimmune disease impact treatment and outcomes among patients with lung cancer? A national SEER-Medicare analysis.
Authors: Khan S.A. , Pruitt S.L. , Xuan L. , Makris U. , Gerber D.E. .
Source: Lung Cancer (amsterdam, Netherlands), 2018 Jan; 115, p. 97-102.
EPub date: 2017-11-24 00:00:00.0.
PMID: 29290269
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Revisiting A Longstanding Clinical Trial Exclusion Criterion: Impact Of Prior Cancer In Early-stage Lung Cancer
Authors: Pruitt S.L. , Laccetti A.L. , Xuan L. , Halm E.A. , Gerber D.E. .
Source: British Journal Of Cancer, 2017-03-14 00:00:00.0; 116(6), p. 717-725.
PMID: 28196065
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Prevalence Of Autoimmune Disease Among Patients With Lung Cancer: Implications For Immunotherapy Treatment Options
Authors: Khan S.A. , Pruitt S.L. , Xuan L. , Gerber D.E. .
Source: Jama Oncology, 2016-11-01 00:00:00.0; 2(11), p. 1507-1508.
PMID: 27262099
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Prior cancer does not adversely affect survival in locally advanced lung cancer: A national SEER-medicare analysis.
Authors: Laccetti A.L. , Pruitt S.L. , Xuan L. , Halm E.A. , Gerber D.E. .
Source: Lung Cancer (amsterdam, Netherlands), 2016 Aug; 98, p. 106-13.
PMID: 27393515
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Should criteria for inclusion in cancer clinical trials be expanded?
Authors: Gerber D.E. , Pruitt S.L. , Halm E.A. .
Source: Journal Of Comparative Effectiveness Research, 2015 Aug; 4(4), p. 289-91.
PMID: 26274789
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Effect of prior cancer on outcomes in advanced lung cancer: implications for clinical trial eligibility and accrual.
Authors: Laccetti A.L. , Pruitt S.L. , Xuan L. , Halm E.A. , Gerber D.E. .
Source: Journal Of The National Cancer Institute, 2015 Apr; 107(4), .
EPub date: 2015-02-09 00:00:00.0.
PMID: 25667420
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