Funding Oncology Clinical Trials: Are Cooperative Group Trials Sustainable?

Seow, Hsien; Whelan, Patrick; Levine, Mark; Cowan, Kathryn; Lysakowski, Barbara; Kowaleski, Brenda; Snider, Anne; Xu, Rebecca; Arnold, Andrew

doi:10.1200/jco.2011.37.2698

Cited by 20 publications

(15 citation statements)

References 9 publications

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“…On the other hand, certain barriers to opening CCTs may apply across adult centers, such as the financial burden of conducting NCTN studies compared with industry trials (although it is notable that existing industry CCTs were equally unavailable for AYAs in our study). 19 Thus, strategies that reduce burden for institutions in opening AYA-relevant phase 3 trials are likely to be impactful. In this regard, the NCI Central IRB approval process has lessened the burden for scientific review at the local sites.…”

Section: Discussionmentioning

confidence: 99%

A prospective comparison of cancer clinical trial availability and enrollment among adolescents/young adults treated at an adult cancer hospital or affiliated children’s hospital

Schlüter

Malvar

Tran

et al. 2018

Cancer

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Background: Low cancer clinical trial (CCT) enrollment may contribute to survival disparities affecting adolescents and young adults (AYAs, 15–39 years). This study evaluated whether differences in CCT availability related to treatment site could explain this low CCT enrollment. Methods: This prospective, observational cohort study was conducted at an academic children’s hospital and its affiliated but geographically separated adult cancer hospital within a National Cancer Institute-designated comprehensive cancer center. For consecutive, newly-diagnosed AYA patients, it was determined whether an appropriate CCT existed nationally, was available at the treatment site, and was utilized for enrollment. Proportions of AYAs in these categories were compared between sites using the χ2test. Results: One hundred fifty-two consecutive AYA patients were included from the children’s hospital (n=68, aged 15–20 years) and adult cancer hospital (n=84, aged 18–39 years). Although there was no difference in CCT existence for individual AYA patients by site (children’s hospital 36/68 [52.9%] versus adult cancer hospital 45/84 [53.6%], p=0.938), CCT availability was significantly lower at the adult cancer hospital (14/84 [16.7%] versus 30/68 [44.1%], p<0.001). The proportion of AYAs enrolled was low at both sites (8/68 [11.8%] versus 6/84 [7.1%], p=0.327). Fewer existing CCTs were available at the adult cancer hospital (4/27 [14.8%] versus 8/14 [57.1%], respectively), and those were directed toward solid tumors and new agents. Conclusions: Efforts to improve low CCT enrollment among AYAs should be differentiated by treatment site. In the adult setting, these should be aimed at improving CCT availability by overcoming site-level barriers to opening existing CCTs.

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Section: Discussionmentioning

confidence: 99%

A prospective comparison of cancer clinical trial availability and enrollment among adolescents/young adults treated at an adult cancer hospital or affiliated children’s hospital

Schlüter

Malvar

Tran

et al. 2018

Cancer

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“…Attribution of research costs is complex and recovery of those costs, particularly for non-commercial clinical trials is very challenging (Snowdon et al , 2006; Seow et al , 2012). Costs incurred by conducting a clinical trial can broadly be attributed to one of the three elements (Attributing the costs of health and social care Research & Development (AcoRD), 2012): (1) research costs, that is, the costs of the trial itself, which end when the research ends and relate to activities being undertaken to answer the research question; (2) treatment costs, that is, the patient care costs, which would continue to be incurred if the patient care intervention continued to be provided after the trial had stopped; and (3) service support costs, that is, the additional patient care costs associated with the research, which would end once the trial had stopped, even if the patient care involved continued to be provided.…”

mentioning

confidence: 99%

Treatment costs associated with interventional cancer clinical trials conducted at a single UK institution over 2 years (2009–2010)

et al. 2013

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Background:The conduct of clinical trials should be an integral part of routine patient care. Treating patients in trials incurs additional costs over and above standard of care (SOC), but the extent of the cost burden is not known. We undertook a retrospective cost attribution analysis to quantitate the treatment costs associated with cancer clinical trial protocols conducted over a 2 year period.Methods:All patients entered into oncology (non-haematology) clinical trials involving investigational medicinal products in 2009 and 2010 in a single UK institution were identified. The trial protocols on which they were treated were analysed to identify the treatment costs for the experimental arm(s) of the trial and the equivalent SOC had the patient not been entered in the trial. The treatment cost difference was calculated by subtracting the experimental treatment cost from SOC cost. For randomised trials, an average treatment cost was estimated by taking into account the number of arms and randomisation ratio. An estimate of the annual treatment costs was calculated.Results:A total of 357 adult oncology patients were treated on 53 different trial protocols: 40 phase III, 2 randomised II/III and 11 phase II design. A total of 27 trials were academic, non-commercial sponsored trials and 26 were commercial sponsored trials. When compared with SOC, the average treatment cost per patient was an excess of £431 for a non-commercial trial (range £6393 excess to £6005 saving) and a saving of £9294 for a commercial trial (range £0 to £71 480). There was an overall treatment cost saving of £388 719 in 2009 and £496 556 in 2010, largely attributable to pharmaceutical company provision of free drug supplies.Conclusion:On an average, non-commercial trial protocols were associated with a small per patient excess treatment cost, whereas commercial trials were associated with a substantially higher cost saving. Taking into account the total number of patients recruited annually, treatment of patients on clinical trial protocols was associated with considerable cost savings across both the non-commercial and commercial portfolio.

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“…Paying up-front lump sums per patient at time of inclusion is common in noncommercial trials. However, it does not correspond to actual cost accruement for trials with patients who continue in a trial over a long period of time [14].…”

Section: Discussionmentioning

confidence: 99%

Estimating site costs prior to conducting clinical trials

Arenz¹,

Hero²,

Eichhorst³

et al. 2014

Clinical Investigation

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Conducting clinical trials is costly and time consuming. Trial sites usually do not calculate site costs. Underestimating required resources slows enrollment and lowers data quality but it is currently unclear how to reliably estimate trial site costs. A group of trial staff designed and validated a tool for compiling trial tasks and calculating required expenditures prior to initiating a clinical trial. The tool was validated in two steps. Round-robin tests for accuracy compared case payments for the same trial calculated by different participants. A narrow CI was reached (22.95-715.69) demonstrating significantly similar estimates of the test participants (p = 0.039). To confirm the predictive value, the predicted and actual hours were compared and a correlation coefficient of 0.952 (p = 0.003) was found. A web-based tool, the Study Site Budgeting Tool, was developed, which allows trial sites to estimate staff costs at the site and determine the budget needed to conduct a clinical trial.

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Funding Oncology Clinical Trials: Are Cooperative Group Trials Sustainable?

Cited by 20 publications

References 9 publications

A prospective comparison of cancer clinical trial availability and enrollment among adolescents/young adults treated at an adult cancer hospital or affiliated children’s hospital

A prospective comparison of cancer clinical trial availability and enrollment among adolescents/young adults treated at an adult cancer hospital or affiliated children’s hospital

Treatment costs associated with interventional cancer clinical trials conducted at a single UK institution over 2 years (2009–2010)

Estimating site costs prior to conducting clinical trials

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