Advancing Academic Cancer Clinical Trials Recruitment in Canada

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.

Download Full-text

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

Tumori Journal ◽

10.1177/030089160509100420 ◽

2005 ◽

Vol 91 (4) ◽

pp. 373-379 ◽

Cited By ~ 2

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.

Download Full-text

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

Cancers ◽

10.3390/cancers12113251 ◽

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.

Download Full-text

Early closure of clinical trials: The experience of the National Cancer Institute of Canada Clinical Trials Group

Journal of Clinical Oncology ◽

10.1200/jco.2006.24.18_suppl.6053 ◽

2006 ◽

Vol 24 (18_suppl) ◽

pp. 6053-6053 ◽

Cited By ~ 1

Author(s):

W. Parulekar ◽

J. L. Pater

Keyword(s):

Clinical Trials ◽

Meta Analysis ◽

Phase Iii ◽

External Information ◽

Efficacy Analysis ◽

Time Period ◽

Number Of Patients ◽

Early Closure ◽

Phase Iii Studies ◽

Over Time

6053 Background: Phase III studies require a significant commitment on behalf of researchers and patients. Closure of a study before the originally planned number of patients have been enrolled may be due to a number of reasons such as poor accrual, information within the study that precludes continuation such as excess toxicity, an interim futility or extreme efficacy analysis or data from outside sources that render the study question obsolete. Methods: We reviewed the phase III activity of our group since inception. Reasons for early closure were classified in the following manner: accrual failure (AF), external information (EI), internal information (II). Studies were grouped by site and time period of study activation to demonstrate any trends over time. Results: 94 phase III studies led by our group were identified from our roster. Reasons for early closure are presented below. Other sites include brain with an early closure due to AF, head/neck where 1 of 3 studies closed due to AF, melanoma where 1 of 3 studies closed due to EI and sarcoma where 2 studies were successfully completed. Several of the studies that closed for accrual failure were nevertheless published either singly or as part of a meta-analysis. Conclusions: Slightly over one third of studies closed prior to achievement of the targeted sample size. Accrual failure continues to be the main cause of early study closure (27/34 or 80%) with a trend towards decreasing frequency of occurrence over time. Emerging data within or external to a study leading to study closure are important but relatively rare reasons for early closure. [Table: see text] No significant financial relationships to disclose.

Download Full-text