Clinical Trial Metrics: The Complexity of Conducting Clinical Trials in North American Cancer Centers

Abstract

PURPOSE: Cancer clinical trials offices (CTOs) support the investigation of cancer prevention, early detection, and treatment at cancer centers across North America. CTOs are a centralized resource for clinical trial conduct and typically use research staff with expertise in four functional areas of clinical research: finance, regulatory, clinical, and data operations. To our knowledge, there are no publicly available benchmark data sets that characterize the size, cost, volume, and efficiency of these offices, nor whether the metrics differ by National Cancer Institute (NCI) designation. The Association of American Cancer Institutes (AACI) Clinical Research Innovation (CRI) steering committee developed a survey to address this knowledge gap. METHODS: An 11-question survey that addressed CTO budget, accrual and trial volume, full-time equivalents (FTEs), staff turnover, and activation timelines was developed by the AACI CRI steering committee and sent to 92 academic cancer research centers in North America (n = 90 in the United States; n = 2 in Canada), with 79 respondents completing the survey (86% completion rate). RESULTS: The number of FTE employees working in the CTOs ranged from 4.5 to 811 (median, 104). The median number of analytic cases (ie, newly diagnosed or received first course of treatment) reported by the main center was 3,856. Annual CTO budgets ranged from $250,000 to $23,900,000 (median, $8.2 million). The median trial activation time, based on 61 centers, was 167 days. The median number of accruals per center was 480 (range, 5-6,271) and median number of trials per center was 282 (range, 31-1,833). Budget and FTE ranges varied by NCI designation. CONCLUSION: The response rate to the survey was high. These data will allow cancer centers to evaluate their CTO infrastructure, funding, portfolio, and/or accrual goals as compared with peers. A wide range in each of the outcomes was noted, in keeping with the wide variation in size and scope of cancer center CTOs across the United States and Canada. These variations may warrant additional investigation.

Incivility Is Associated with Burnout and Reduced Compassion Satisfaction: A Mixed-Method Study to Identify Causes of Burnout among Oncology Clinical Research Coordinators

“…Organizational policies to improve the ways that CRCs are treated by patients and providing CRCs with tools to manage patient and family incivility will be important in reducing their burnout levels. Given that burnout is a primary motivation cited by CRCs for leaving the job [45], and CRC turnover is an ongoing problem in academic cancer centers [2], addressing this factor has the potential to be critical.…”

“…Clinical research coordinators (CRCs) play a vital role in clinical research activities and interactions with clinical study participants, and they are integral to the success of the clinical trials upon which most oncology advances depend [1,2]. However, CRCs report high levels of emotional exhaustion and similar or worse levels of burnout [3], compared to other health care professionals experiencing a well-documented epidemic of burnout [4][5][6][7][8][9][10][11].…”

The Next Horizon of Drug Development: External Control Arms and Innovative Tools to Enrich Clinical Trial Data

“…Successful execution of clinical trials (CTs) has always been a significant challenge for drug development [ 1 ]. Over the past decade, the magnitude and impact of clinical trials have grown significantly due to their complexity, multifaceted design, and challenging operational requirements (e.g., complex tissue sampling, and molecular and processing requirements).…”

Feasibility, Acceptability, and Preliminary Effectiveness of a Compassion-Centered Team Intervention to Improve Clinical Research Coordinator Resilience and Well-Being

“…15 Burnout among CRCs is of concern because coordinators play a critical role in clinical research activities and interactions with clinical study participants 16 and are integral to the success of the clinical trials upon which most advances in the treatment of cancer depend. 17 Not only is CRC turnover a significant problem and financial burden for the clinical trial offices in academic oncology centers, but also coordinator attrition is a risk factor for attrition of other coordinators, since the loss of staff leads to extra stress and burnout among remaining CRCs. 17 Moreover, it is clear that clinical team collaboration, cohesion, and trust-all found to be protective against burnout [18][19][20] -are also critical for trial success.…”

“…17 Not only is CRC turnover a significant problem and financial burden for the clinical trial offices in academic oncology centers, but also coordinator attrition is a risk factor for attrition of other coordinators, since the loss of staff leads to extra stress and burnout among remaining CRCs. 17 Moreover, it is clear that clinical team collaboration, cohesion, and trust-all found to be protective against burnout [18][19][20] -are also critical for trial success. 21 Extensive research indicates that the presence of positive social support among colleagues reduces burnout and improves job performance 22 and attitudes.…”