A National Cancer Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program

Scoggins, John F.; Ramsey, Scott D.

doi:10.1093/jnci/djq291

Cited by 131 publications

(44 citation statements)

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“…To our knowledge, this investigation represents the most comprehensive study of accrual failure. [4][5][6] Our findings, though troubling, paint a less grim picture than if we had chosen a cut-off for unsuccessful accrual of 100%; in that case, the fraction of trials failing to achieve enrolment targets would have risen to 29%, much lower than the fraction reported by the NCI in 2010. 13 We further explored factors associated with failure to achieve sufficient accrual to address primary research questions.…”

Section: Discussionmentioning

confidence: 62%

“…4 A subsequent IOM report indicated that 40% or more NCI-sponsored phase 3 trials failed to meet accrual goals. 5 An NCI study of 149 trials estimated that 28.3% would fail to achieve 90% of their accrual goals. 6 Louis Lasagna famously observed that when trial recruitment starts, "the supply of suitable patients becomes a fraction of what it was assumed to be before the trial began."…”

Section: Introductionmentioning

confidence: 99%

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Unsuccessful trial accrual and human subjects protections: An empirical analysis of recently closed trials

et al. 2014

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Section: Discussionmentioning

confidence: 62%

Section: Introductionmentioning

confidence: 99%

Unsuccessful trial accrual and human subjects protections: An empirical analysis of recently closed trials

et al. 2014

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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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“…[5][6][7][8][9][10] A recent NCI report found that 50% of all phase III NCI studies close prematurely, due in part to poor accrual, and just this year an analysis of 238 clinical trials across five US co-operative groups determined that 29% closed specifically as a result of poor accrual. 11,12 Low enrolment rates in clinical trials have frequently been attributed to patient-related factors, such as lack of awareness, fear of being subjected to experimental maltreatment, desire to receive standard therapy, or geographic distance from centers that offer trials. [13][14][15] Widespread efforts to improve patient perception and knowledge of clinical trials have led to better public awareness and perception of clinical trials, although these efforts have thus far yielded little improvement in overall clinical trial participation among patients with cancer.…”

Section: Introductionmentioning

confidence: 99%

Screening Intervention to Identify Eligible Patients and Improve Accrual to Phase II-IV Oncology Clinical Trials

Chen

Grant

Cheung

et al. 2013

JOP

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Purpose: Low enrolment rates in clinical trials present a barrier to the development of novel cancer therapies. Currently, only 3% of patients with cancer participate, and many studies fail to achieve necessary enrolment. The objective of this study was to evaluate whether a screening intervention to identify potentially eligible patients (PEPs) would increase accrual rates. Patients and Methods:Over a 4-month intervention period, PEPs for 21 phase II-IV breast, gastrointestinal, genitourinary, gynecology, and lung cancer trials were identified by a screening coordinator. This individual reviewed the electronic medical records of patients attending outpatient clinics and flagged PEPs for 10 medical oncologists at the BC Cancer Agency. Patients who were already documented to be trial eligible by physicians were not flagged. Oncologists were surveyed regarding the helpfulness and accuracy of the intervention.Results: During the intervention period, 73 patients were enrolled, compared with 61 patients enrolled in the 4 months prior and 51 patients in the 4 months after. A total of 2,098 charts were reviewed, and 120 PEPs were identified during the intervention period, resulting in 19 PEPs who enrolled and four PEPs who declined a clinical trial. Relative accrual rates adjusted for oncologist appointments were 0.85 (P ϭ .15) before and 0.70 (P Ͻ .005) after, relative to the intervention period. Oncologist-returned surveys indicated that 67% of flags were helpful, and 70% were accurate. Conclusions:In this study, manually screening patient records increased enrolment to specific clinical trials. A screening intervention process, involving a dedicated screening coordinator, should be considered to improve clinical trial accrual.

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A National Cancer Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program

Cited by 131 publications

References 0 publications

Unsuccessful trial accrual and human subjects protections: An empirical analysis of recently closed trials

Unsuccessful trial accrual and human subjects protections: An empirical analysis of recently closed trials

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

Screening Intervention to Identify Eligible Patients and Improve Accrual to Phase II-IV Oncology Clinical Trials

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