Barriers to Study Enrollment in Patients With Advanced Cancer Referred to a Phase I Clinical Trials Unit

Fu, Siqing; McQuinn, Lacey; Naing, Aung; Wheler, Jennifer J.; Janků, Filip; Piha-Paul, Sarina A.; Tu, Dennis; Howard, Adrienne; Tsimberidou, Apostolia M.; Zinner, Ralph; Hong, David S.; Kurzrock, Razelle

doi:10.1634/theoncologist.2013-0202

Cited by 18 publications

(18 citation statements)

References 31 publications

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“…Our study in the pediatric setting is consistent with the findings of studies on failure to include adults in phase I trials, showing that the main reason is rapid deterioration of health status between the time of proposal and the planned inclusion date.…”

Section: Discussionsupporting

confidence: 88%

Enrollment in early‐phase clinical trials in pediatric oncology: The experience at Institut Curie

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Dujaric

Aerts

et al. 2018

Pediatric Blood & Cancer

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Section: Discussionsupporting

confidence: 88%

Enrollment in early‐phase clinical trials in pediatric oncology: The experience at Institut Curie

Surun

Dujaric

Aerts

et al. 2018

Pediatric Blood & Cancer

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“…Cancer clinical trials help advance the standard of care and often represent the best available treatment option for patients with cancer, yet only a small fraction of eligible patients participate [1][2][3][4].The reasonsfortheselowtrialparticipationratesaremyriad and include financial and logistical barriers [3,[5][6][7][8]. 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].…”

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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“…First, as is always inherent to retrospective methodology, the selection bias of patient referral to our phase I clinical trials program may limit the generalizability of our findings. The rate of phase I clinical trial enrollment for patients with HG-EOC (74%) is significantly higher than the average patient enrollment rate in phase I trials at our institution (~55%), as we previously described [44]. Second, small sample sizes in the subgroup analyses limit the validity of these statistical assessments.…”

Section: Discussionmentioning

confidence: 72%

Continuous anti-angiogenic therapy after tumor progression in patients with recurrent high-grade epithelial ovarian cancer: phase I trial experience

et al. 2016

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High-grade epithelial ovarian cancer (HG-EOC) is the most lethal gynecologic malignancy worldwide Once patients develop chemoresistance, effective novel strategies are required to improve prognosis We analyzed characteristics and outcomes of 242 consecutive patients with HG-EOC participating in 94 phase I clinical trials at The University of Texas MD Anderson Cancer Center. Baseline lactate dehydrogenase levels, albumin levels, and number of metastatic sites were independent predictors of overall survival (OS). Receiving more than 1 phase I protocol was associated with improved OS (p < 0.001). Regimens including a chemotherapeutic agent plus bevacizumab or Aurora A kinase inhibitor led to a median progression-free survival (PFS) duration of more than 6 months. Although patients receiving bevacizumab-based regimens in the phase I clinical trials had significantly longer PFS than those receiving other anti-angiogenic therapies (p = 0.017), patients treated with vascular endothelial growth factor receptor-tyrosine kinase inhibitors (VEGFR-TKIs) had significantly longer OS (12.2 months) than those not treated with VEGFR-TKIs (8.6 months, p = 0.015).In conclusion, anti-angiogenic therapy is one of the most important strategies for the treatment of HG-EOC, even in those who have already experienced tumor progression. Therefore, eligible patients with HG-EOC should be encouraged to participate in novel phase I studies of anti-angiogenic therapies, even after disease progression.

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Barriers to Study Enrollment in Patients With Advanced Cancer Referred to a Phase I Clinical Trials Unit

Abstract: Learning Objectives Assess barriers for advanced cancer patients to participate in phase I trials. Discuss strategies to improve the rate of enrollment of cancer patients in phase I trials.

Cited by 18 publications

References 31 publications

Enrollment in early‐phase clinical trials in pediatric oncology: The experience at Institut Curie

Enrollment in early‐phase clinical trials in pediatric oncology: The experience at Institut Curie

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

Continuous anti-angiogenic therapy after tumor progression in patients with recurrent high-grade epithelial ovarian cancer: phase I trial experience

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