Cost of Insurance Policies for Investigator-Initiated Cancer Clinical Trials in Italy

2005 ◽  
Vol 91 (4) ◽  
pp. 373-379 ◽  
Author(s):  
Francesco Perrone ◽  
Maurizio Marangolo ◽  
Francesco Di Costanzo ◽  
Giuseppe Colucci ◽  
Lazzaro Repetto ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Cancer Clinical Trials ◽  
Clinical Perspective ◽  
Non Profit ◽  
Insurance Policies ◽  
Insurance Cost ◽  
Cancer Trials ◽  
The Cost ◽  
Source Of Information ◽  
Over Time

Background Clinical trials with non-profit promoters are frequently performed in oncology and represent a highly valuable source of information. Methods To describe the costs of insurance policies and their determinants, data were collected from 12 Italian non-profit promoters of cancer trials. The cost of policies was expressed as per-patient premium. Results Sixty-two quotations issued by only two companies were collected, relative to 44 trials proposed for quotation between December 1998 and February 2003. Only the date of quotation was significantly associated with the cost (P = 0.0003) of quotations by Company A for policies with a deductible, with cost increasing over time. Date of quotation (P = 0.0002), sample size (P = 0.008) and number of study arms (P = 0.02) were independently associated with the cost of no-deductible policies quoted by Company A. Only the number of study arms was significantly associated with cost (P = 0.0001) in no-deductible policies quoted by Company B. Conclusion There is insufficient competition among companies for insurance of cancer trials with non-profit promoters. Many variables that affect the trial risk profile from a clinical perspective are not associated with insurance cost. Date of quotation is among the strongest determinants of the cost, which has sharply increased over time. This trend may become a serious problem for non-profit promoters of cancer clinical trials.

Measuring the Incremental Cost of Clinical Cancer Research

2001 ◽  
Vol 19 (1) ◽  
pp. 105-110 ◽  
Author(s):  
Dana P. Goldman ◽  
Michael L. Schoenbaum ◽  
Arnold L. Potosky ◽  
Jane C. Weeks ◽  
Sandra H. Berry ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Cancer Treatment ◽  
Incremental Cost ◽  
Cancer Patients ◽  
Phase Ii ◽  
The United States ◽  
Phase Iii ◽  
Ongoing Effort ◽  
Cancer Trials ◽  
The Cost

PURPOSE: To summarize evidence on the costs of treating patients in clinical trials and to describe the Cost of Cancer Treatment Study, an ongoing effort to produce generalizable estimates of the incremental costs of government-sponsored cancer trials. METHODS: A retrospective study of costs will be conducted with 1,500 cancer patients recruited from a randomly selected sample of institutions in the United States. Patients accrued to either phase II or phase III National Cancer Institute–sponsored clinical trials during a 15-month period will be asked to participate in a study of their health care utilization (n = 750). Costs will be measured approximately 1 year after their trial enrollment from a combination of billing records, medical records, and an in-person survey questionnaire. Similar data will be collected for a comparable group of cancer patients not in trials (n = 750) to provide an estimate of the incremental cost. RESULTS: Evidence suggests insurers limit access to trials because of cost concerns. Public and private efforts are underway to change these policies, but their permanent status is unclear. Previous studies found that treatment costs in clinical trials are similar to costs of standard therapy. However, it is difficult to generalize from these studies because of the unique practice settings, insufficient sample sizes, and the exclusion of potentially important costs. CONCLUSION: Denials of coverage for treatment in a clinical trial limit patient access to trials and could impede clinical research. Preliminary estimates suggest changes to these policies would not be expensive, but these results are not generalizable. The Cost of Cancer Treatment Study is an ongoing effort to provide generalizable estimates of the incremental treatment cost of phase II and phase III cancer trials. The results should be of great interest to insurers and the research community as they consider permanent ways to finance cancer trials.

scholarly journals Adverse Event Burden Score—A Versatile Summary Measure for Cancer Clinical Trials

Cancers ◽  
2020 ◽  
Vol 12 (11) ◽  
pp. 3251
Author(s):  
Jennifer G. Le-Rademacher ◽  
Shauna Hillman ◽  
Elizabeth Storrick ◽  
Michelle R. Mahoney ◽  
Peter F. Thall ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Adverse Event ◽  
Treatment Cycle ◽  
Controlled Trials ◽  
Cancer Clinical Trials ◽  
Weighted Sum ◽  
Summary Measure ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Over Time

This article introduces the adverse event (AE) burden score. The AE burden by treatment cycle is a weighted sum of all grades and AEs that the patient experienced in a cycle. The overall AE burden score is the total AE burden the patient experienced across all treatment cycles. AE data from two completed Alliance multi-center randomized double-blind placebo-controlled trials, with different AE profiles (NCCTG 97-24-51: 176 patients, and A091105: 83 patients), were utilized for illustration. Results of the AE burden score analyses corroborated the trials’ primary results. In 97-24-51, the overall AE burden for patients on the treatment arm was 2.2 points higher than those on the placebo arm, with a higher AE burden for patients who went off treatment early due to AE. Similarly, in A091105, the overall AE burden was 1.6 points higher on the treatment arm. On the placebo arms, the AE burden in 97-24-51 remained constant over time; and increased in later cycles in A091105, likely attributable to the increase in disease morbidity. The AE burden score enables statistical comparisons analogous to other quantitative endpoints in clinical trials, and can readily accommodate different trial settings, diseases, and treatments, with diverse AE profiles.

scholarly journals Report on a Delphi process and workshop to improve accrual to cancer clinical trials

2016 ◽  
Vol 23 (2) ◽  
pp. 125 ◽  
Author(s):  
J.A.H. Bell ◽  
L.G. Balneaves ◽  
M.T. Kelly ◽  
H. Richardson
Keyword(s):  
Clinical Trials ◽  
Present Report ◽  
Knowledge Exchange ◽  
Evidence Based ◽  
Cancer Clinical Trials ◽  
Research Collaborations ◽  
Effective Interventions ◽  
Key Stakeholders ◽  
Cancer Trials ◽  
Living With Cancer

Cancer clinical trials (ccts) are essential for furthering knowledge and developing effective interventions to improve the lives of people living with cancer in Canada. Randomized controlled trials are particularly important for developing evidence-based health care interventions. To produce robust and relevant research conclusions, timely and sufficient accrual to ccts is essential.The present report delivers the key recommendations emerging from a workshop meeting, Improve Accrual to Cancer Clinical Trials, that was hosted by the Canadian Cancer Trials Group and funded by the Canadian Institutes of Health Research. The meeting, which took place in Toronto, Ontario, in April 2012 before the Canadian Cancer Trials Group annual spring meeting, brought together key stakeholders from across Canada to explore creative strategies for improving accrual to ccts. The objectives of the workshop were to provide an opportunity for knowledge exchange with respect to the research evidence and the ethics theory related to cct accrual and to promote discussion of best practices and policies related to enhancing cct access and accrual in Canada.The workshop provided the foundation for establishing new interdisciplinary research collaborations to overcome the identified barriers to cct participation in Canada. Meeting participants also supported the development of evidence-based policies and practices to make trials more accessible to Canadians living with cancer.

Premature termination of genitourinary cancer clinical trials.

2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 288-288 ◽  
Author(s):  
Kristian D. Stensland ◽  
Russell McBride ◽  
Juan P. Wisnivesky ◽  
Asma Latif ◽  
Ryan Hendricks ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Premature Termination ◽  
Cox Regression ◽  
Testis Cancer ◽  
Cancer Clinical Trials ◽  
Clinical Cancer Research ◽  
Kaplan Meier ◽  
Substantial Resource ◽  
The Usa ◽  
Cancer Trials

288 Background: The GU oncology literature is inundated with clinical trials that terminated prematurely, particularly in bladder cancer. Such trials require substantial resource expenditure and entail the time, trust, and commitment of patients, yet contribute minimally to the scientific knowledgebase and divert resources from answering critical questions. We sought to determine the scope of this problem within the clinical trials enterprise. Methods: ClinicalTrials.gov was queried to identify all phase II-III interventional adult cancer clinical trials registered between 9/11/05 and 11/11/11. Prematurely terminated trials were “stopped early” as defined by the registry. Kaplan-Meier methods and Cox regression were used to determine risk of premature trial termination. Results: We identified 7,776 trials, including 491 prostate (PCa), 142 kidney, 75 bladder, and 34 testis cancer trials. The risk of premature termination due to any cause for all cancers was 25% (95% CI 19-31%) and the risk due to poor accrual was 10% (95% CI 9-12%). Poor accrual was the most common reason for premature termination (Table). Risk was not significantly different for kidney, bladder or testis cancers compared to other cancer types with the exception of PCa (HR 1.35 [1.03-1.78]). Industry-funded trials were more likely to terminate prematurely (HR 2.26 [1.83-2.80]). Trials with sites outside of the USA (HR 0.63 [0.54-0.74]) or both within and outside of the USA (HR 0.68 [0.54-0.74]) were less likely to terminate prematurely as were trials with multiple sites (HR 0.56 [0.48-0.64]). Conclusions: In this large cohort of clinical trials, ~1 in 4 trials terminated prematurely (1 in 10 due to poor accrual). GU cancer trials were at similar risk of termination compared to other cancer clinical trials with the exception of PCa. Novel approaches are needed to improve the efficiency of the clinical cancer research enterprise. [Table: see text]

Accrual of older adults to cancer clinical trials led by the Canadian cancer trials group – Is trial design a barrier?

2020 ◽  
Vol 11 (3) ◽  
pp. 455-462 ◽  
Author(s):  
Catalina Hernandez-Torres ◽  
Winson Y. Cheung ◽  
Shiying Kong ◽  
Chris J. O'Callaghan ◽  
Tina Hsu
Keyword(s):  
Older Adults ◽  
Clinical Trials ◽  
Trial Design ◽  
Cancer Clinical Trials ◽  
Cancer Trials

scholarly journals Gender and sex disparity in cancer trials

ESMO Open ◽  
2020 ◽  
Vol 5 (Suppl 4) ◽  
pp. e000773 ◽  
Author(s):  
Eudocia Lee ◽  
Patrick Wen
Keyword(s):  
Clinical Trials ◽  
Elderly Women ◽  
Phase Iii ◽  
Cancer Clinical Trials ◽  
Phase Iii Clinical Trials ◽  
The Usa ◽  
Study Population ◽  
Cancer Trials ◽  
Early Phase Clinical Trials ◽  
Sex Disparity

The study population within phase III clinical trials leading to approval of new cancer agents should ideally more closely mirror the population who will ultimately receive these agents. Although the number of females participating in clinical trials has increased over the past several decades, females are still under-represented in preclinical studies, in early phase clinical trials and even in some later phase cancer clinical trials. In the USA, this is particularly true for women from minority populations and elderly women. In this review, we review gender and sex disparities in cancer trials, the reasons for these disparities, the barriers to clinical trial enrolment and ways to improve diversity in cancer clinical trials.

scholarly journals Advancing Academic Cancer Clinical Trials Recruitment in Canada

2021 ◽  
Vol 28 (4) ◽  
pp. 2830-2839
Author(s):  
Rebecca Y. Xu ◽  
Diana Kato ◽  
Gregory R. Pond ◽  
Stephen Sundquist ◽  
James Schoales ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Performance Measures ◽  
Success Factors ◽  
Descriptive Statistics ◽  
Cancer Clinical Trials ◽  
Predictive Success ◽  
Time Period ◽  
Site Characteristics ◽  
Recruitment Target ◽  
Over Time

The Canadian Cancer Clinical Trials Network (3CTN) was established in 2014 to address the decline in academic cancer clinical trials (ACCT) activity. Funding was provided to cancer centres to conduct a Portfolio of ACCTs. Larger centres received core funding and were paired with smaller centres to enable support and sharing of resources. All centres were eligible for incentive-based funding for recruitment above pre-3CTN baseline. Established performance measures were collected and tracked. The overall recruitment target was 50% above pre-3CTN baseline by Year 4. An analysis was completed to identify predictive success factors and descriptive statistics were used to summarize site characteristics and outcomes. From 2014–2018, a total of 11,275 patients were recruited to 559 Portfolio trials, an overall increase of 59.6% above pre-3CTN baseline was observed in Year 4. Twenty-five (51%) adult centres met the Year 4 recruitment target and the overall recruitment target was met within three years. Three factors that correlated with sites’ achieving recruitment targets were: time period, region and number of baseline trials. 3CTN was successful in meeting its objectives and will continue to support ACCTs and member cancer centres, monitor performance over time and seek continued funding to ensure success, better trial access and outcomes for patients.

scholarly journals Incremental costs of prostate cancer trials: Are clinical trials really a burden on a public payer system?

2013 ◽  
Vol 7 (3-4) ◽  
pp. e231-6 ◽  
Author(s):  
Britney Jones ◽  
Rachel Syme ◽  
Misha Eliasziw ◽  
Bernhard J. Eigl
Keyword(s):  
Prostate Cancer ◽  
Clinical Trials ◽  
Resource Utilization ◽  
Treatment Strategies ◽  
Standard Of Care ◽  
Cost Distribution ◽  
Observational Cohort ◽  
Cancer Trials ◽  
Public Payer ◽  
The Cost

Introduction: Clinical trials are a critical component of improving cancer prevention and treatment strategies. However, the perception that patients enrolled in trials consume more resources than those receiving the standard-of-care (SOC) has contributed to an increasingly research-averse environment. Current economic data pertaining to the per-patient costs of prostate cancer trials relative to SOC treatment are limited.Methods: A retrospective observational cohort study was conducted to compare costs incurred by 59 prostate cancer patients participating in a mix of industry and non-industry sponsored clinical trials with costs incurred by an equal number of eligible nonparticipants who received SOC over a year. Resource utilization was tracked and quantified to standardized price templates.Results: No difference in overall resource utilization was seen between trial and SOC patients (two-tailed t-test, n = 118, p = 0.99). Variability in the types of resources used by each group indicated that, while trial patients may take up significantly more clinic time (p = 0.001) and undergo more tests and procedures (p = 0.001), SOC patients are more likely to receive other costly interventions, such as radiation therapy (p < 0.001). Other variables (e.g., pathology, diagnostic imaging, prescribed therapies) were statistically indistinguishable between groups.Conclusion: This study revealed differences in the cost distribution of patients enrolled in clinical trials versus those receiving SOC, which could be used to improve resource allocation. The lack of evidence for a difference in overall cost provides an argument for payers to more fully support clinical research without fear of adverse financial consequences. Further analysis is required.

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