Disparities in older adult accrual to cancer trials: Analysis from the alliance for clinical trials in oncology (A151736)

2021 ◽  
Author(s):  
Noam A. VanderWalde ◽  
Travis Dockter ◽  
Daniel V. Wakefield ◽  
Daniel Satele ◽  
Jeff Sloan ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Older Adult ◽  
Cancer 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 Do oncology patients understand clinical trials? A nationwide study by Cancer Trials Ireland

2017 ◽  
Vol 28 ◽  
pp. v643-v644 ◽  
Author(s):  
C.M. Kelly ◽  
R. Feighery ◽  
J. McCaffrey ◽  
M. Higgins ◽  
M. Smith ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Oncology Patients ◽  
Nationwide Study ◽  
Cancer Trials

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.

scholarly journals Barriers to conducting cancer trials in Canada: an analysis of key informant interviews

2020 ◽  
Vol 27 (3) ◽  
Author(s):  
C. Bentley ◽  
S. Sundquist ◽  
J. Dancey ◽  
S. Peacock
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Health Care Professionals ◽  
Leading Edge ◽  
Spillover Effects ◽  
Comparative Approach ◽  
Software Application ◽  
Canadian Health ◽  
Oncology Clinical Trials ◽  
Cancer Trials

Background In Canada, there is growing evidence that oncology clinical trials units (ctus) and programs face serious financial challenges. Investment in cancer research in Canada has declined almost 20% in the 5 years since its peak in 2011, and the costs of conducting leading-edge trials are rising. Clinical trials units must therefore be strategic about which studies they open. We interviewed Canadian health care professionals responsible for running cancer trials programs to identify the barriers to sustainability that they face. Methods One-on-one telephone interviews were conducted with clinicians and clinical research professionals at oncology ctus in Canada. We asked for their perspectives about the barriers to conducting trials at their institutions, in their provinces, and nationwide. Interviews were digitally recorded, transcribed, anonymized, and coded in the NVivo software application (version 11: QSR International, Melbourne, Australia). The initial coding structure was informed by the interview script, with new concepts drawn out and coded during analysis, using a constant comparative approach. Results Between June 2017 and November 2018, 25 interviews were conducted. Key barriers that participants identified were ■ insufficient stable funding to support trials infrastructure and retain staff; ■ the need to adopt strict cost-recovery policies, leading to fewer academic trials in portfolios; and ■ an overreliance on industry to fund clinical research in Canada. Conclusions Funding uncertainties have led ctus to increasingly rely on industry sponsorship and more stringent feasibility thresholds to remain solvent. Retaining skilled trials staff can create efficiencies in opening and running studies, with spillover effects of more trials being open to patients. More academic studies are needed to curb industry’s influence.  

Barriers to participation in breast cancer trials

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 6593-6593
Author(s):  
O. Herasme ◽  
J. Goldberg ◽  
R. Sandoval ◽  
C. Harris ◽  
Y. Ortiz-Pride ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Child Care ◽  
Cancer Patients ◽  
Controlled Trial ◽  
Demographic Factors ◽  
Trial Participation ◽  
Barriers To Participation ◽  
Cancer Trials

6593 Background: Clinical cancer trials allow investigators to test the effectiveness and safety of new cancer drugs and treatments. Historically, fewer that 5% of cancer patients have participated in clinical trials. The purpose of this study was to assess attitudes, beliefs, and practical barriers to clinical trial recruitment. Methods: Women were recruited in the Herbert Irving Comprehensive Cancer Center while waiting for routine breast screening or for oncology care in connection with a diagnosis of breast cancer. The 29-item survey questionnaire covered demographic factors, prior cancer diagnosis or risk factors, past experience with clinical trials if any, willingness to participate in different types of trials, and attitudinal and practical barriers to participation. Results: Of 329 respondents, 48.9% were non- Hispanic white, 10.9% non-Hispanic black, 34.9% Hispanic, and 5.30% other/unknown. The mean age of participants was 52.5 (SD=12.1). Of 131 (39.8%) participants reporting that they had been asked to participate in clinical trial, 82 were white, 17 black and 32 Hispanic. Of those who enrolled, 64 were white, 14 were black, and 19 Hispanic. Of those asked to participate 56/63 breast cancer patients (88.9%) and 44/68 others (64.7%) enrolled (P=0.002). Of 48 who reported that they had child care responsibilities, 33 enrolled (68.8) compared to 67/83 (80.7%) of those without such responsibilities (P=0.07). Of the total sample, 88/220 (40.0%) of those without childcare responsibilities but only 32/109 (29.4) said they would be willing to participate in a placebo-controlled trial. Respondents were twice as likely to say they would participate in a trial comparing two active agents as a placebo-controlled trial. Conclusion: Our findings suggest that being asked to participate in a clinical trial may be associated with demographic factors, and that specific circumstances, such as child care responsibilities, may also affect trial participation. Awareness of these barriers may help investigators to develop effective strategies for overcoming them and for improving trial participation overall. No significant financial relationships to disclose.

scholarly journals Implementing a Geriatric Assessment in Cooperative Group Clinical Cancer Trials: CALGB 360401

2011 ◽  
Vol 29 (10) ◽  
pp. 1290-1296 ◽  
Author(s):  
Arti Hurria ◽  
Constance T. Cirrincione ◽  
Hyman B. Muss ◽  
Alice B. Kornblith ◽  
William Barry ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Geriatric Assessment ◽  
Health Care Professionals ◽  
Assessment Tool ◽  
Healthcare Providers ◽  
Psychological State ◽  
Cooperative Group ◽  
Group Setting ◽  
Assessment Measures ◽  
Cancer Trials

Purpose Factors captured in a geriatric assessment can predict morbidity and mortality in older adults, but are not routinely measured in cancer clinical trials. This study evaluated the implementation of a geriatric assessment tool in the cooperative group setting. Patients and Methods Patients age ≥ 65 with cancer, who enrolled on cooperative group cancer trials, were eligible to enroll on Cancer and Leukemia Group B (CALGB) 360401. They completed a geriatric assessment tool before initiation of protocol therapy, consisting of valid and reliable geriatric assessment measures which are primarily self-administered and require minimal resources and time by healthcare providers. The assessment measures functional status, comorbidity, cognitive function, psychological state, social support, and nutritional status. The protocol specified criteria for incorporation of the tool in future cooperative group trials was based on the time to completion and percent of patients who could complete their portion without assistance. Patient satisfaction with the tool was captured. Results Of the 93 patients who enrolled in this study, five (5%) met criteria for cognitive impairment and three did not complete the cognitive screen, leaving 85 assessable patients (median age, 72 years). The median time to complete the geriatric assessment tool was 22 minutes, 87% of patients (n = 74) completed their portion without assistance, 92% (n = 78) were satisfied with the questionnaire length, 95% (n = 81) reported no difficult questions, and 96% (n = 82) reported no upsetting questions. One hundred percent of health care professionals completed their portion. Conclusion This brief, primarily self-administered geriatric assessment tool met the protocol specified criteria for inclusion in future cooperative group clinical trials.

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