Predicting Low Accrual in the National Cancer Institute’s Cooperative Group Clinical Trials

Bennette, Caroline S.; Ramsey, Scott D.; McDermott, Cara L.; Carlson, Josh J.; Basu, Anirban; Veenstra, David L.

doi:10.1093/jnci/djv324

Cited by 73 publications

(92 citation statements)

References 18 publications

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“…As a result, investigators may overestimate the availability of eligible patients and underestimate the challenges in actually accruing those patients. A recent analysis found that greater accrual competition, in the form of more trials in the same disease setting, and fewer available patients were significant predictors of low accrual in NCI group trials (13). A more feasible method of estimating the number of patients eligible, able, and potentially willing to participate in any given trial is needed.…”

Section: Introductionmentioning

confidence: 99%

Challenges Facing Early Phase Trials Sponsored by the National Cancer Institute: An Analysis of Corrective Action Plans to Improve Accrual

Massett

Mishkin

Rubinstein

et al. 2016

Clinical Cancer Research

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Section: Introductionmentioning

confidence: 99%

Challenges Facing Early Phase Trials Sponsored by the National Cancer Institute: An Analysis of Corrective Action Plans to Improve Accrual

Massett

Mishkin

Rubinstein

et al. 2016

Clinical Cancer Research

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“…This puts increasing pressure on the current research system, as large numbers of patients are required to assess relevance or superiority before their implementation into clinical practice. This warranted large number greatly exceeds the amount of patients that currently participate in clinical trials (5-15%) [14][15][16]. Low recruitment rates may also imply selective inclusion of patients in trials rather than representative population samples [17], which may result in limited external validity of outcomes.…”

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confidence: 99%

“…However, this design in itself is often not only complicated by slow recruitment rates and limited generalizability [15], it is also subject to a considerable delay between conceptualization and start, limited long-term follow-up, inadequate collection of patient-reported outcomes (PROMs), high non-completion rates and high costs [16]. An innovative alternative proposed for the classic RCT is the 'cohort multiple randomized controlled trial' (cmRCT) [20].…”

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confidence: 99%

Prospective Dutch colorectal cancer cohort: an infrastructure for long-term observational, prognostic, predictive and (randomized) intervention research

et al. 2016

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Background: Systematic evaluation and validation of new prognostic and predictive markers, technologies and interventions for colorectal cancer (CRC) is crucial for optimizing patients' outcomes. With only 5-15% of patients participating in clinical trials, generalizability of results is poor. Moreover, current trials often lack the capacity for post-hoc subgroup analyses. For this purpose, a large observational cohort study, serving as a multiple trial and biobanking facility, was set up by the Dutch Colorectal Cancer Group (DCCG). Methods/design: The Prospective Dutch ColoRectal Cancer cohort is a prospective multidisciplinary nationwide observational cohort study in the Netherlands (yearly CRC incidence of 15 500). All CRC patients (stage I-IV) are eligible for inclusion, and longitudinal clinical data are registered. Patients give separate consent for the collection of blood and tumor tissue, filling out questionnaires, and broad randomization for studies according to the innovative cohort multiple randomized controlled trial design (cmRCT), serving as an alternative study design for the classic RCT. Objectives of the study include: 1) systematically collected long-term clinical data, patient-reported outcomes and biomaterials from daily CRC practice; and 2) to facilitate future basic, translational and clinical research including interventional and cost-effectiveness studies for both national and international research groups with short inclusion periods, even for studies with stringent inclusion criteria. Results: Seven months after initiation 650 patients have been enrolled, eight centers participate, 15 centers await IRB approval and nine embedded cohort-or cmRCT-designed studies are currently recruiting patients. Conclusion: This cohort provides a unique multidisciplinary data, biobank, and patient-reported outcomes collection initiative, serving as an infrastructure for various kinds of research aiming to improve treatment outcomes in CRC patients. This comprehensive design may serve as an example for other tumor types.

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“…Only 3/22 (14%) were accruing at less than half the rate planned, a benchmark for triggering a formal review of studies sponsored by National Cancer Institute (NCI)’s Cancer Therapy Evaluation Program. While this is similar to cooperative group oncology trials (14), selective reporting of quantitative imaging trials that had better accrual may have occurred. In addition, a group heavily invested in quantitative imaging research (ie, the NCI’s QIN) may have the expertise required for optimizing the chances of successful accrual.…”

Section: Discussionmentioning

confidence: 62%

Accrual Patterns for Clinical Studies Involving Quantitative Imaging: Results of an NCI Quantitative Imaging Network (QIN) Survey

et al. 2016

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Patient accrual is essential for the success of oncology clinical trials. Recruitment for trials involving the development of quantitative imaging biomarkers may face different challenges than treatment trials. This study surveyed investigators and study personnel for evaluating accrual performance and perceived barriers to accrual and for soliciting solutions to these accrual challenges that are specific to quantitative imaging-based trials. Responses for 25 prospective studies were received from 12 sites. The median percent annual accrual attained was 94.5% (range, 3%–350%). The most commonly selected barrier to recruitment (n = 11/25, 44%) was that “patients decline participation,” followed by “too few eligible patients” (n = 10/25, 40%). In a forced choice for the single greatest recruitment challenge, “too few eligible patients” was the most common response (n = 8/25, 32%). Quantitative analysis and qualitative responses suggested that interactions among institutional, physician, and patient factors contributed to accrual success and challenges. Multidisciplinary collaboration in trial design and execution is essential to accrual success, with attention paid to ensuring and communicating potential trial benefits to enrolled and future patients.

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Predicting Low Accrual in the National Cancer Institute’s Cooperative Group Clinical Trials

Abstract: Background:The extent to which trial-level factors differentially influence accrual to trials has not been comprehensively studied. Our objective was to evaluate the empirical relationship and predictive properties of putative risk

Cited by 73 publications

References 18 publications

Challenges Facing Early Phase Trials Sponsored by the National Cancer Institute: An Analysis of Corrective Action Plans to Improve Accrual

Challenges Facing Early Phase Trials Sponsored by the National Cancer Institute: An Analysis of Corrective Action Plans to Improve Accrual

Prospective Dutch colorectal cancer cohort: an infrastructure for long-term observational, prognostic, predictive and (randomized) intervention research

Accrual Patterns for Clinical Studies Involving Quantitative Imaging: Results of an NCI Quantitative Imaging Network (QIN) Survey

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