Use of the National Cancer Institute Community Cancer Centers Program Screening and Accrual Log to Address Cancer Clinical Trial Accrual

Germain, Diane St.; Denicoff, Andrea; Dimond, Eileen; Carrigan, Angela; Enos, Rebecca A.; González, M. M.; Wilkinson, Kathy; Mathiason, Michelle A.; Duggan, Brenda; Einolf, Shaun; McCaskill‐Stevens, Worta; Bryant, Donna; Thompson, Michael A.; Grubbs, Stephen S.; Go, Ronald S.

doi:10.1200/jop.2013.001194

Cited by 45 publications

(44 citation statements)

References 25 publications

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“…As depicted by National Cancer Institute reports (5), many factors should be considered when weighing the real benefits of cancer screening programs (6). Regarding brain cancer, one can easily identify several issues that preclude an obvious advantage of systematic screening: its low incidence and prevalence; the cost of neuroradiologic imaging and its false-positive results (normal variations resembling subtle abnormalities), leading to anxiety and unnecessary costly invasive diagnostic and therapeutic procedures that may follow, namely brain biopsies and craniotomies.…”

Section: Discussionmentioning

confidence: 99%

Screening for Brain Cancer: Why (Not)

Alves

Santiago

2014

World Neurosurgery

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Section: Discussionmentioning

confidence: 99%

Screening for Brain Cancer: Why (Not)

Alves

Santiago

2014

World Neurosurgery

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“…19 Other potential processes include the use of electronic medical records and the development of clinical trial screening logs that can assist in the identification of institutionspecific accrual patterns. 20,21 To our knowledge, this study provides the first comprehensive trend analysis of enrollment disparities in lung cancer treatment trials spanning more than two decades sponsored by the NCI-cooperative groups. Our clinical trial data represent approximately 84% of participants with lung cancer in NCI cooperative group treatment trials that were activated between 1990 and 2010, making our estimates of trial enrollment characteristics robust and representative.…”

Section: Discussionmentioning

confidence: 99%

“…The results were consistent for both of the major histologic subtypes of NSCLC, adenocarcinoma and squamous cell carcinoma (Data Supplement). For elderly patients with SCLC, there was no change in the proportion of trial participants over time (APC,20.20 [95% CI,21.29 to 0.91]; P = .714) despite an increase in the proportion of elderly patients with SCLC in the US population (APC, 0.32 [95% CI, 0.06 to 0.58]; P = .020). The EDD and EDR for elderly patients with SCLC in trials in 2010 to 2012 were high, at 0.35 (95% CI, 0.29 to 0.41) and 3.82 (95% CI, 2.59 to 6.88), respectively (Fig 2C and Data Supplement).…”

Section: Elderly Patients By Lung Cancer Typementioning

confidence: 99%

Enrollment Trends and Disparity Among Patients With Lung Cancer in National Clinical Trials, 1990 to 2012

Pang

Wang

Stinchcombe

et al. 2016

JCO

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Under-representation of elderly, women, and racial/ethnic minority patients with cancer in clinical trials is of national concern. The goal of this study was to characterize enrollment trends and disparities by age, sex, and race/ethnicity in lung cancer trials. MethodsWe analyzed data for 23,006 National Cancer Institute cooperative group lung cancer trial participants and 578,476 patients with lung cancer from the SEER registry from 1990 to 2012. The enrollment disparity difference (EDD) and enrollment disparity ratio (EDR) were calculated on the basis of the proportion of each subgroup in the trial population and the US lung cancer population. Annual percentage changes (APCs) in the subgroup proportions in each population were compared over time. Results Enrollment disparity for patients ConclusionUnder-representation in lung cancer trials improved significantly from 1990 to 2012 for elderly patients with non-small-cell lung cancer and for women, but ongoing efforts to improve the enrollment of elderly patients with SCLC and minorities are needed. Our study highlights the importance of addressing enrollment disparities by demographic and disease subgroups to better target under-represented groups of patients with lung cancer.

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“…Recruitment is jeopardised by many factors including restrictive eligibility criteria and inefficient methods for approaching potential participants [5, 6]. Screening logs may help inform the representativeness of a RCT [7], but they may also be informative for understanding why eligible patients are not recruited [8, 9]. …”

Section: Introductionmentioning

confidence: 99%

Reasons for non-recruitment of eligible patients to a randomised controlled trial of secondary prevention after intracerebral haemorrhage: observational study

Maxwell

MacLeod

Joyson

et al. 2017

Trials

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BackgroundRecruitment to randomised prevention trials is challenging, not least for intracerebral haemorrhage (ICH) associated with antithrombotic drug use. We investigated reasons for not recruiting apparently eligible patients at hospital sites that keep screening logs in the ongoing REstart or STop Antithrombotics Randomised Trial (RESTART), which seeks to determine whether to start antiplatelet drugs after ICH.MethodBy the end of May 2015, 158 participants had been recruited at 108 active sites in RESTART. The trial coordinating centre invited all sites that kept screening logs to submit screening log data, followed by one reminder. We checked the integrity of data, focused on the completeness of data about potentially eligible patients and categorised the reasons they were not randomised.ResultsOf 108 active sites, 39 (36%) provided usable screening log data over a median of ten (interquartile range = 5–13) months of recruitment per site. During this time, sites screened 633 potentially eligible patients and randomised 53 (8%) of them. The main reasons why 580 patients were not randomised were: 43 (7%) patients started anticoagulation, 51 (9%) patients declined, 148 (26%) patients’ stroke physicians were not uncertain about using antiplatelet drugs, 162 (28%) patients were too unwell and 176 (30%) patients were not randomised due to other reasons.ConclusionRESTART recruited ~8% of eligible patients. If more physicians were uncertain about the therapeutic dilemma that RESTART is addressing, RESTART could have recruited up to four times as many participants. The trial coordinating centre continues to engage with physicians about their uncertainty.Trial registrationEU Clinical Trials, EudraCT 2012-003190-26. Registered on 3 July 2012.

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Use of the National Cancer Institute Community Cancer Centers Program Screening and Accrual Log to Address Cancer Clinical Trial Accrual

Abstract: Use of screening logs to document enrollment barriers at the local level can facilitate development of strategies to enhance clinical trial accrual.

Cited by 45 publications

References 25 publications

Screening for Brain Cancer: Why (Not)

Screening for Brain Cancer: Why (Not)

Enrollment Trends and Disparity Among Patients With Lung Cancer in National Clinical Trials, 1990 to 2012

Reasons for non-recruitment of eligible patients to a randomised controlled trial of secondary prevention after intracerebral haemorrhage: observational study

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