Challenges to National Cancer Institute–Supported Cooperative Group Clinical Trial Participation: An ASCO Survey of Cooperative Group Sites

Baer, Allison R.; Kelly, Chelsey A.; Bruinooge, Suanna S.; Runowicz, Carolyn D.; Blayney, Douglas W.

doi:10.1200/jop.200028

Cited by 20 publications

(15 citation statements)

References 9 publications

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“…However, even this increased rate is not adequate to completely cover all labor costs, per subject enrollment costs, and additional research-related paperwork and reporting requirements 23. The response by the cooperative group member sites has been dramatic, with 42% planning or considering limiting accruals to cooperative group trials 24 due to per-case reimbursement or staffing issues.…”

Section: Discussionmentioning

confidence: 99%

Phase III Clinical Trial Development: A Process of Chutes and Ladders

Dilts

Cheng

Crites

et al. 2010

Clinical Cancer Research

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Purpose: The Institute of Medicine report on cooperative groups and the National Cancer Institute (NCI) report from the Operational Efficiency Working Group both recommend changes to the processes for opening a clinical trial. This article provides evidence for the need for such changes by completing the first comprehensive review of all the time and steps required to open a phase III oncology clinical trial and discusses the effect of time to protocol activation on subject accrual.Methods: The Dilts and Sandler method was used at four cancer centers, two cooperative groups, and the NCI Cancer Therapy Evaluation Program. Accrual data were also collected.Results: Opening a phase III cooperative group therapeutic trial requires 769 steps, 36 approvals, and a median of approximately 2.5 years from formal concept review to study opening. Time to activation at one group ranged from 435 to 1,604 days, and time to open at one cancer center ranged from 21 to 836 days. At centers, group trials are significantly more likely to have zero accruals (38.8%) than nongroup trials (20.6%; P < 0.0001). Of the closed NCI Cancer Therapy Evaluation Program-approved phase III clinical trials from 2000 to 2007, 39.1% resulted in <21 accruals.Conclusions: The length, variability, and low accrual results demonstrate the need for the NCI clinical trials system to be reengineered. Improvements will be of only limited effectiveness if done in isolation; there is a need to return to the collaborative spirit with all parties creating an efficient and effective system. Recommendations put forth by the Institute of Medicine and Operational Efficiency Working Group reports, if implemented, will aid this renewal.

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Section: Discussionmentioning

confidence: 99%

Phase III Clinical Trial Development: A Process of Chutes and Ladders

Dilts

Cheng

Crites

et al. 2010

Clinical Cancer Research

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“…It became possible not only due to the early diagnostics and realizations of the programs of populational screening but also at the expanse of intensification of antitumor therapy methods [2].…”

Section: Introductionmentioning

confidence: 99%

Influence of Long-Term Cytotoxic Chemotherapy on the Condition of Peripheral Venous Channel

Tkachuk

2017

EUREKA: Health Sciences

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The necessity of long-term venous access in cancer patients appears at frequent and long-term courses of cytotoxic therapy. Peripheral veins of forearms are most often used for these aims. The conditions of peripheral venous channel in 32 cancer patients, who underwent the long-term treatment with antitumor preparations were analyzed in the article on own investigatory material. The methods of dopplerography, morphological and immunohystochemical studies were used. The qualitative and quantitative dopplerographic changes in forearm veins in different terms after chemotherapy start were revealed in most patients. The conclusion was made about unsuitability of forearm peripheral veins for the long term administration of cytostatics and the necessity to create the alternative vascular access that would correspond to the criteria of safety, reliability and long-term exploitation.

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“…In spite of this declining funding, the number of patients enrolled in Cooperative Group trials has been steady over the last 5 five years (Figure 2). The Program has always relied on a spirit of volunteerism among participating clinicians and institutions, but recent surveys indicate that we are approaching a tipping point at which participation is no longer seen as feasible (4). …”

Section: Introductionmentioning

confidence: 99%

A National Cancer Clinical Trials Network: Recommendations From the Institute of Medicine

Nass¹,

Balogh

Mendelsohn

2011

American Journal of Therapeutics

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Oncology has become one of the most active areas of drug discovery, with more than 800 cancer therapeutics in development. This presents an unprecedented opportunity to improve the outcome for patients with cancer, but also requires an effective and efficient clinical trials network to generate the evidence necessary for regulatory approval and optimal integration of new treatments into clinical care. The Clinical Trials Cooperative Group Program supported by the National Cancer Institute has been instrumental in establishing standards of care in oncology over the last 50 years, but it currently faces numerous challenges that threaten its ability to undertake the large-scale, multi-institutional trials that advance patient care. The Institute of Medicine recently appointed a consensus study committee to assess the organization and operation of the Cooperative Group Program and recommend ways to improve the quality of cancer clinical trials conducted by the Groups and others. The committee developed a set of recommendations, summarized here, that aim to improve the speed and efficiency of trials; incorporate innovative science and trial design; improve prioritization, selection, and support of trials; and increase participation by patients and physicians.

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Challenges to National Cancer Institute–Supported Cooperative Group Clinical Trial Participation: An ASCO Survey of Cooperative Group Sites

Abstract: Anecdotal information regarding clinical research sites limiting participation in NCI-funded cooperative group studies prompted ASCO to collect data on and investigate the reasons behind this trend.

Cited by 20 publications

References 9 publications

Phase III Clinical Trial Development: A Process of Chutes and Ladders

Phase III Clinical Trial Development: A Process of Chutes and Ladders

Influence of Long-Term Cytotoxic Chemotherapy on the Condition of Peripheral Venous Channel

A National Cancer Clinical Trials Network: Recommendations From the Institute of Medicine

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