How Many Cancer Clinical Trials Can a Clinical Research Coordinator Manage? The Clinical Research Coordinator Workload Assessment Tool.

PURPOSE: Cancer clinical trials (CTs) are now more complex than ever before and require dedicated personnel (clinical research coordinators [CRCs]) to perform regulatory and administrative activities and protocol- and patient-related procedures. We developed a simple tool to measure the workload (WL) of CRCs involved in cancer research and to estimate personnel requirements within a Clinical Trial Center. METHODS: A literature review and 2-month period in which CRCs recorded their activities in a diary provided valuable information that led to the Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori Workload Assessment Tool (IWAT) being divided into three sections: Protocol, On-Treatment Patients, and Follow-Up Patients. Twelve full-time senior CRCs from three sites of the Network measured their monthly WL for 30 months to evaluate IWAT reproducibility and accuracy. RESULTS: The IWAT proved to be a user-friendly tool (3-6 minutes required for each CT), with high reproducibility (interobserver reproducibility ranged from 82% to 100% for each IWAT item). In December 2017, the Network had 185 ongoing CTs, with a median of 2.5 active centers for each CT. On the basis of 448 total IWAT measures by CRCs, the majority of trials were academic (57%) or dealt with advanced disease (77%). The median IWAT WL score for each study was 20.98 ± 22.90 (range, 2-188) and 475 ± 229 (range, 150 [junior staff] - 930 [extreme heavy WL]) for each CRC. On the basis of our experience, a monthly WL score of 500-600 was considered an appropriate value for a full-time CRC. CONCLUSION: The IWAT could prove useful in evaluating CT complexity, estimating appropriate CRC WLs, and defining personnel requirements. Independent validation by other CRCs working in different organizational contexts and in different countries is needed.

Receipt of adjuvant systemic therapy among patients with high-risk breast cancer detected by mammography screening.

BACKGROUND: Few studies have compared screen-detected (SD) breast cancer patients with symptomatic patients for the frequency and determinants of receipt of adjuvant systemic therapy according to accepted guidelines. METHODS: Depending on the date of diagnosis, adjuvant therapy guidelines from the 5th, 6th, and 7th St. Gallen International Conferences were used as standards to audit the treatment of 598 node-negative high-risk patients (59% SD) and 430 node-positive patients (40% SD) aged 50-69 years from an Italian cancer registry (1997-2001). Odds ratios (OR) and 95% confidence intervals (CI) were calculated using backward stepwise logistic regression models. RESULTS: Among node-negative high-risk patients, SD cancers were smaller (P = 0.000) and of lower grade (P = 0.003). Downgrading was generally from grade 3 to grade 2, with an increased proportion of patients placed in the high-risk category due to grade 2 alone. The total rates of adjuvant systemic therapy were similar (58 vs. 60%) whereas SD patients were less often treated according to the guidelines (34 vs. 45%; OR = 0.61; 95% CI, 0.44-0.86). After adjustment for tumour size and other weaker confounders, the OR was 0.99 (95% CI, 0.67-1.46). Among node-positive patients, the OR of receiving the standard adjuvant systemic therapy did not differ between SD and symptomatic cancers. CONCLUSIONS: SD cancers amplified the prognostic heterogeneity of node-negative high-risk patients. Their lower likelihood of being treated according to the guidelines was largely explained by their lower risk profile. No evidence was found to suggest that physicians held a priori assumptions about the relative biological indolence of SD cancers.

Patients' understanding of clinical research: An Italian cancer patient survey.

INTRODUCTION:: Patients' awareness of clinical research and their involvement in clinical trials is of great importance, but it is difficult to estimate the extent of knowledge on the research being undertaken. METHODS:: We evaluated the level of knowledge about clinical research using a self-reporting survey distributed to 967 adult patients with cancer attending the Departments of Medical Oncology and Onco-Haematology Units of IRST IRCCS and 4 hospitals in the region of Emilia-Romagna, Italy. The questionnaire was composed of 10 specific items on research knowledge. Patients responding correctly to at least 8 of the 10 items were considered to have a good understanding of clinical research. RESULTS:: The questionnaire was completed by 769 patients (response rate 79.5%). Only 19% of patients were found to have a good understanding of clinical research. Patients with higher education and those who had previous clinical trial experience showed a significantly better understanding. Fifty-three percent of patients said that they would be willing to participate in a trial studying a new drug and 75% expressed an interest in taking part in informative meetings/events about clinical studies. CONCLUSIONS:: Our results show that patients' understanding of clinical research is limited and highlight an interest in learning more.