Enrollment of Elderly Patients in Clinical Trials for Cancer Drug Registration: A 7-Year Experience by the US Food and Drug Administration

Talarico, Lilia; Chen, Gang; Pazdur, Richard

doi:10.1200/jco.2004.02.175

Cited by 652 publications

(371 citation statements)

References 30 publications

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“…Previous studies have also shown that older patients are less likely to be enrolled in clinical trials because of various factors compared to their younger counterparts. [25][26][27] Their impact is evident as the gaps between observed and expected enrollment rates of women were significantly reduced after accounting for age-and genderspecific differences in expected disease prevalence.…”

Section: Discussionmentioning

confidence: 99%

The Impact of Cardiovascular Disease Prevalence on Women's Enrollment in Landmark Randomized Cardiovascular Trials: A Systematic Review

et al. 2011

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Many studies have demonstrated that women are substantially underrepresented in cardiovascular trials, but few have considered that women develop cardiovascular disease at older ages than men. The extent to which observed gender enrollment inequalities persist after accounting for age-gender differences in disease prevalence is unknown. The purpose of the study was to compare observed rates of women participating in cardiovascular clinical trials with expected rates of female participation based on age-and gender-specific population disease prevalence. Publications between 1997 and 2009 in the three leading medical journals were included to calculate observed women's enrollment rates. Population-based data in Canada were used to determine the expected enrollment rates of women. Multicenter, randomized cardiovascular clinical trials that enrolled both men and women were analyzed. Two reviewers independently extracted data on women's enrollment and important clinical trial characteristics. The female enrollment rate was 30% in the included 325 trials, which ranged from 27% in trials of coronary artery disease, 27% in heart failure, 31% in arrhythmia, to 45% in primary prevention. Increased female enrollment correlated strongly with increasing age at recruitment in cardiovascular clinical trials (P< 0.001). After accounting for age-and gender-specific differences in disease prevalence, gaps in female enrollment were much lower than the expected enrollment rates estimated by 5% in coronary artery disease, 13% in heart failure, 9% in arrhythmia, and 3% in primary prevention. Only cardiovascular trials were evaluated in our study. Female underrepresentation in cardiovascular clinical trials is smaller than conventionally believed after accounting for age-and gender-specific population disease prevalence. Our findings suggest that greater representation of women in cardiovascular clinical trials can be achieved through the recruitment of older populations.

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Section: Discussionmentioning

confidence: 99%

The Impact of Cardiovascular Disease Prevalence on Women's Enrollment in Landmark Randomized Cardiovascular Trials: A Systematic Review

et al. 2011

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“…Numerous analyses report a startling underrepresentation of the elderly in cancer clinical trials, creating an evidence gap for the treatment of this large patient population [2][3][4][5]. Selective entry criteria and the patient referral process contribute to this problem.…”

Section: Introductionmentioning

confidence: 99%

Disparities in the Use of Chemotherapy and Monoclonal Antibody Therapy for Elderly Advanced Colorectal Cancer Patients in the Community Oncology Setting

et al. 2008

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After completing this course, the reader will be able to:1. Identify reported differences between advanced colorectal cancer patients treated in community oncology clinics and those enrolled in clinical trials.2. Describe gaps in the existing evidence for the treatment of elderly advanced colorectal cancer patients.3. Describe the need for improving tools to appropriately select patients for treatment.This article is available for continuing medical education credit at CME.TheOncologist.com. CME CME ABSTRACTBackground. The clinical trials on which the treatment of advanced colorectal (CRC) is based enroll few elderly patients. Furthermore, few investigations have determined the use and outcomes of the treatment of advanced CRC in practice. This study evaluated the treatment of advanced CRC in community oncology practices, focusing on age-related differences in treatment and outcome.

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“…In particular, groups with historically lower financial resources, such as uninsured and minority patients, are frequently underrepresented in cancer clinical trials [1,[9][10][11]. Conversely, study participants of higher socioeconomic status (SES) are over-represented in cancer clinical trials [12][13][14][15].…”

Section: Introductionmentioning

confidence: 99%

Financial Burden of Cancer Clinical Trial Participation and the Impact of a Cancer Care Equity Program

et al. 2016

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Introduction. Cancer clinical trial (CT) participation rates are low and financial barriers likely play a role. We implemented a cancer care equity program (CCEP) to address financial burden associated with trial participation. We sought to examine the impact of the CCEP on CT enrollment and to assess barriers to participation. Methods. We used an interrupted time series design to determine trends in CT enrollment before and after CCEP implementation. Linear regression models compared trial enrollment before and after the CCEP. We also compared patient characteristics before and after the CCEP and between CCEP and non-CCEP participants. We surveyed CCEP and non-CCEP participants to compare preenrollment financial barriers. Results. After accounting for increased trial availability and the trends in accrual for prior years, we found that enrollment increased after CCEP implementation (18.97 participants per

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Enrollment of Elderly Patients in Clinical Trials for Cancer Drug Registration: A 7-Year Experience by the US Food and Drug Administration

Abstract: Elderly were under-represented in the registration trials of new cancer therapies. Various strategies may be needed to evaluate cancer therapies for the elderly in prospective clinical trials and to improve cancer care in the elderly population.

Cited by 652 publications

References 30 publications

The Impact of Cardiovascular Disease Prevalence on Women's Enrollment in Landmark Randomized Cardiovascular Trials: A Systematic Review

The Impact of Cardiovascular Disease Prevalence on Women's Enrollment in Landmark Randomized Cardiovascular Trials: A Systematic Review

Disparities in the Use of Chemotherapy and Monoclonal Antibody Therapy for Elderly Advanced Colorectal Cancer Patients in the Community Oncology Setting

Financial Burden of Cancer Clinical Trial Participation and the Impact of a Cancer Care Equity Program

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