Racial/ethnic differences in clinical trial enrollment, refusal rates, ineligibility, and reasons for decline among patients at sites in the National Cancer Institute's Community Cancer Centers Program

Langford, Aisha T.; Resnicow, Ken; Dimond, Eileen; Denicoff, Andrea; Germain, Diane St.; McCaskill‐Stevens, Worta; Enos, Rebecca A.; Carrigan, Angela; Wilkinson, Kathy; Go, Ronald S.

doi:10.1002/cncr.28483

Cited by 102 publications

(101 citation statements)

References 18 publications

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“…13,14,20,21,22,27 The dominant reason for ineligibility exclusions is likely exclusions due to comorbid conditions. One recent paper comprehensively catalogued the trial eligibility criteria for a set of 21 trials in diverse cancer settings.…”

Section: Understanding Barriers To Clinical Trial Participationmentioning

confidence: 99%

The Role of Clinical Trial Participation in Cancer Research: Barriers, Evidence, and Strategies

Unger

Cook²,

Tai

et al. 2016

American Society of Clinical Oncology Educational Book

297

298

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OVERVIEW Fewer than 1 in 20 adult cancer patients enroll in cancer clinical trials. But although barriers to trial participation have been the subject of frequent study, the rate of trial participation has not changed substantially over time. Barriers to trial participation are structural, clinical, and attitudinal, and differ according to demographic and socioeconomic factors. In this paper, we characterize the nature of cancer clinical trial barriers, and we consider global and local strategies for reducing barriers. We also consider the specific case of adolescents with cancer, and show that the low rate of trial enrollment in this age group strongly correlates with limited improvements in cancer population outcomes compared to other age groups. Our analysis suggests that a clinical trial system that enrolls patients at higher rates produces treatment advances at a faster rate and corresponding improvements in cancer population outcomes. Viewed in this light, the issue of clinical trial enrollment is foundational, lying at the heart of the cancer clinical trial endeavor. Fewer barriers to trial participation would allow trials to be completed more quickly and would improve the generalizability of trial results. Moreover, increased accrual to trials is important to patients, since trials provide patients the opportunity to receive the newest treatments. In an era of increasing emphasis on a treatment decision-making process that incorporates the patient perspective, the opportunity for patients to choose trial participation for their care is vital.

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Section: Understanding Barriers To Clinical Trial Participationmentioning

confidence: 99%

The Role of Clinical Trial Participation in Cancer Research: Barriers, Evidence, and Strategies

Unger

Cook²,

Tai

et al. 2016

American Society of Clinical Oncology Educational Book

297

298

View full text Add to dashboard Cite

show abstract

“…Among patients at the sites in the National Cancer Institute’s Community Cancer Center’s Program, there was an 18% overall enrollment rate, with a 17% enrollment rate for women, though rates vary by study. 4 The 1993 NIH Revitalization Act mandates that minorities be equally represented in RCTs, yet the minority representation is below 5%. 5,6 Factors associated with reduced participation in underrepresented populations include RCTs awareness, age, socioeconomic status, racial/ethnicity minority status, and comorbidities.…”

Section: Introductionmentioning

confidence: 99%

Motivators and barriers to Latinas' participation in clinical trials: The role of contextual factors

London

Hurtado‐de‐Mendoza

Song

et al. 2015

Contemporary Clinical Trials

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Objective Latinas are underrepresented in clinical trials despite the rise in Hispanic population. This study examines the factors associated with Latinas’ willingness to participate in preventive breast cancer randomized clinical trials (RCTs). Methods Women self-identifying as Latina, over age 40, with no prior history of breast cancer were eligible. Using the Behavior Model for Vulnerable Populations, we administered a survey (n=168) to assess predisposing (e.g., knowledge), enabling (e.g., trust) and need factors (e.g., risk perception). Intention to participate was defined using a lenient (maybe, probably or definitely) and a stringent criterion (probably and definitely). Chi-square tests and logistic regression models examined the associations of predisposing, enabling, and need factors with women’s intentions to participate in RCTs. Results Most participants (74.9%) were monolingual Spanish-speaking immigrants. Most (83.9%) reported willing to participate in clinical trials using the lenient definition (vs. 43.1% under the stringent definition). Using the lenient definition, the odds of willing to participate in RCTs were significantly lower for unmarried women (OR=.25, 95% CI=.08–.79) and those with lower cancer risk perceptions (OR=.20, 95% CI=.06–.63), while being significantly higher for women with lower language acculturation (OR=6.2, 95% CI=1.8–20.9). Using the stringent definition, women who did not endorse a motivation to enroll to help family members (if they had cancer) had significantly lower odds to report intent (OR=.33, 95% CI=.13–.86). Conclusion Many RCTs may have limited generalizability due to the low representation of minorities. Culturally targeted interventions that address the importance of family for Latinos may ultimately increase their participation in RCTs.

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“…15,16 Lastly, the key drivers in tumor biology that confer the discrepant prognosis for black men with prostate cancer remain unknown. If and when these advances are discovered, enrollment based on specific genomic or epigenetic characteristics, rather than simply the phenotype of race, may ultimately be the best way to determine the efficacy of therapy for each individual.…”

Section: Comments and Controversiesmentioning

confidence: 99%

Disparities in Castration-Resistant Prostate Cancer Trials

Spratt

Osborne

2015

JCO

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All progress is precarious, and the solution of one problem brings us face to face with another problem.-Martin Luther King Jr 1(pp82-83) Disparities in health care delivery and outcomes are complex and longstanding. Many such disparities derive from limited access to health care, socioeconomic barriers, and cultural differences-each of which can result in minorities receiving suboptimal care, and ultimately in inferior outcomes. Recently published SEER data again underscore the undeniable disparities in cancer outcomes across ethnic groups.1a Understanding the drivers of these disparities is relevant for all subpopulations, but for black men with prostate cancer, this is especially true, as there are specific action items of timely importance.Black men with prostate cancer have a 2.5-fold greater risk of lethal prostate cancer compared with white men.1a Hispanic men with prostate cancer have demonstrated increased incidence rates and also have inferior survival rates when compared with white males. The increased incidence of advanced prostate cancer among Hispanic men, however, appears to be principally related to barriers in health care access (ie, education level, socioeconomic status, insurance status, and so on); when these factors are corrected for, no significant difference in lethal prostate cancer rates are found (odds ratio: 1.23 [95% CI, 0.73 to 2.08]).2 In contrast, black men appear to retain an independently increased risk for advanced disease despite corrections for access to health care (odds ratio 2.26 [95% CI,

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Racial/ethnic differences in clinical trial enrollment, refusal rates, ineligibility, and reasons for decline among patients at sites in the National Cancer Institute's Community Cancer Centers Program

Cited by 102 publications

References 18 publications

The Role of Clinical Trial Participation in Cancer Research: Barriers, Evidence, and Strategies

The Role of Clinical Trial Participation in Cancer Research: Barriers, Evidence, and Strategies

Motivators and barriers to Latinas' participation in clinical trials: The role of contextual factors

Disparities in Castration-Resistant Prostate Cancer Trials

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