Development and use of a staffing model for clinical research teams at an NCI Comprehensive Cancer Center.

2016 ◽  
Vol 34 (15_suppl) ◽  
pp. e18267-e18267
Author(s):  
Erin Fenske Williams ◽  
Joan H. Schiller ◽  
Joyce D Bolluyt ◽  
David E. Gerber
Keyword(s):  
Clinical Research ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Research Teams ◽  
Staffing Model

scholarly journals Synergetic role of integrating the departments of cancer registry and clinical research at an academic comprehensive cancer center

2017 ◽  
Vol 7 (2) ◽  
pp. 33 ◽  
Author(s):  
McKenzie Bedra ◽  
Tammy Vyskocil ◽  
Jennifer Emel ◽  
Crystal Edwards ◽  
Cherif Boutros
Keyword(s):  
Clinical Research ◽  
Cancer Registry ◽  
Comprehensive Cancer Center ◽  
Cancer Center

Improving the Time to Activation of New Clinical Trials at a National Cancer Institute–Designated Comprehensive Cancer Center

2020 ◽  
Vol 16 (4) ◽  
pp. e324-e332 ◽  
Author(s):  
Erin Williams ◽  
Timothy J. Brown ◽  
Patrice Griffith ◽  
Asal Rahimi ◽  
Rhonda Oilepo ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Quality Improvement ◽  
Clinical Research ◽  
National Cancer Institute ◽  
Six Sigma ◽  
Value Added ◽  
Scientific Committee ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Process Map

PURPOSE: The time it takes a performing site to activate a clinical trial can directly affect the ability to provide innovative and state-of-the-art care to patients. We sought to understand the process of activating an oncology clinical trial at a matrix National Cancer Institute–designated comprehensive cancer center. METHODS: A multidisciplinary team of stakeholders within the cancer center, university, and affiliate hospitals held a retreat to map out the process of activating a clinical trial. We applied classical quality improvement and Six Sigma methodology to determine bottlenecks and non–value-added time in activating a clinical trial. During this process, attention was paid to time to pass through each step, and perceived barriers and bottlenecks were identified through group discussions. RESULTS: The process map identified 66 steps with 12 decision points to activate a new clinical trial. The following two steps were instituted first: allow parallel scientific committee and institutional review board (IRB) review and allow the clinical research coordination committee, a group that determines university interest and feasibility, to review protocols independent of the IRB and scientific committee approval. The clinical research coordination committee continues to track the activation time, and this framework is used to identify additional improvement steps. CONCLUSION: By applying quality improvement methodologies and Six Sigma principles, we were able to identify redundancies in the process to activate a clinical trial. This allowed us to redesign the process of activating a clinical trial at a matrix comprehensive cancer center. More importantly, the process map provides a framework to maintain these gains and implement additional changes and serves as an example to deploy across the campus and at other similar institutions.

Increasing Clinical Trials Accrual at a Comprehensive Cancer Center

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 1266-1266
Author(s):  
Bayard L. Powell ◽  
Debbie Olson ◽  
Robert M. Morrell ◽  
Terry L. Hales ◽  
Kevin P High ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Critical Role ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Point System ◽  
Cancer Clinical Trials ◽  
Treatment Trials ◽  
Academic Year ◽  
Year 2013

Abstract Background: During the academic year 2013 (July 2012-June 2013) our accrual to cancer clinical trials, a critical measure of success for a Comprehensive Cancer Center (CCC), was lower than prior years and below the desired level for CCC core grant renewal. Academic physicians were faced with increasing pressures to meet clinical demands, often at the expense of academic productivity, including clinical research. Methods: Our Dean and clinical leadership committed to support our efforts to increase accrual to clinical trials by providing salary support for our Section on Hematology and Oncology for specific milestones of 5%, 10%, and 15% increases in accrual to all clinical trials and in accrual to treatment (NCI definition) trials. The goal of the faculty was to increase accrual by > 15% to all trials and to treatment trials to maximize the “pool”. To determine how to divide the pool among investigators we developed a point system recognizing clinical investigators for roles as a) PI for trials (with additional points for all accrual to their trials) and b) for entering patients on clinical trials. The point system for both roles (PI and entering patients) was weighted relative to the value of the trial to the CCC, e.g. investigator initiated > cooperative group > industry initiated, and treatment trials >> non-treatment trials. In addition, we awarded points for publications (first and senior author > co-author) and presentations (oral > poster; major national meeting > other meetings). Results: During academic year 2014 (July 2013-June 2014) accrual to all cancer clinical trials increased by 140% (276 to 663) and accrual to treatment trials increased 40% (114 to 160). These increases occurred in both hematologic malignancies (95% all; 16% treatment) where we had a strong track record for accruals, and in solid tumors (200% all; 76% treatment) where our prior record was not as strong. Discussion: Accrual to clinical trials, both treatment and non-treatment improved dramatically. Interpretation of cause and effect is complex. The baseline year (2013) included implementation of a new EMR and the recent year (2014) included recruitment of additional faculty. However, 2014 was complicated by implementation of a new practice plan heavily weighted toward individual RVU production, and a decrease in available co-operative group trials to historically low levels. However, we can conclude that attention to this critical role of clinical investigators is important and can influence behavior. We cannot determine whether financial incentives are needed or whether the funding is one of several potential methods of recognition of the importance of clinical trials. It is possible that the commitment to provide financial support for clinical research demonstrated to clinical investigators that the leadership valued clinical trials activity and this recognition was more important than the actual funds. Future efforts will also need to find ways to recognize/reward clinical trials productivity of groups of investigators for their multidisciplinary contributions to the care of patients on clinical trials, without generating internal competition within the groups. Disclosures No relevant conflicts of interest to declare.

Creating an Effort Tracking Tool to Improve Therapeutic Cancer Clinical Trials Workload Management and Budgeting

2011 ◽  
Vol 9 (11) ◽  
pp. 1228-1233 ◽  
Author(s):  
Pam James ◽  
Patty Bebee ◽  
Linda Beekman ◽  
David Browning ◽  
Mathew Innes ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Data Management ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
University Of Michigan ◽  
Web Based ◽  
Workload Management ◽  
Effective Cost ◽  
The University

Quantifying data management and regulatory workload for clinical research is a difficult task that would benefit from a robust tool to assess and allocate effort. As in most clinical research environments, The University of Michigan Comprehensive Cancer Center (UMCCC) Clinical Trials Office (CTO) struggled to effectively allocate data management and regulatory time with frequently inaccurate estimates of how much time was required to complete the specific tasks performed by each role. In a dynamic clinical research environment in which volume and intensity of work ebbs and flows, determining requisite effort to meet study objectives was challenging. In addition, a data-driven understanding of how much staff time was required to complete a clinical trial was desired to ensure accurate trial budget development and effective cost recovery. Accordingly, the UMCCC CTO developed and implemented a Web-based effort-tracking application with the goal of determining the true costs of data management and regulatory staff effort in clinical trials. This tool was developed, implemented, and refined over a 3-year period. This article describes the process improvement and subsequent leveling of workload within data management and regulatory that enhanced the efficiency of UMCCC's clinical trials operation.

scholarly journals Experience, Perceptions, and Recommendations Concerning COVID-19–Related Clinical Research Adjustments

2021 ◽  
Vol 19 (5) ◽  
pp. 505-512
Author(s):  
David E. Gerber ◽  
Thomas Y. Sheffield ◽  
M. Shaalan Beg ◽  
Erin L. Williams ◽  
Valerie L. Clark ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Research ◽  
Personal Experience ◽  
Positive Impact ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Professional Experience ◽  
Fisher Exact Test ◽  
Detailed Knowledge ◽  
Research Professionals

Background: During the COVID-19 public health emergency, the FDA and NIH altered clinical trial requirements to protect participants and manage study conduct. Given their detailed knowledge of research protocols and regular contact with patients, clinicians, and sponsors, clinical research professionals offer important perspectives on these changes. Methods: We developed and distributed an anonymous survey assessing COVID-19–related clinical trial adjustment experiences, perceptions, and recommendations to Clinical Research Office personnel at the Harold C. Simmons Comprehensive Cancer Center. Responses were compared using the Fisher exact test. Results: A total of 94 of 109 contacted research personnel (87%) responded. Among these individuals, 58% had >5 years’ professional experience in clinical research, and 56% had personal experience with a COVID-19–related change. Respondents perceived that these changes had a positive impact on patient safety; treatment efficacy; patient and staff experience; and communication with patients, investigators, and sponsors. More than 90% felt that positive changes should be continued after COVID-19. For remote consent, telehealth, therapy shipment, off-site diagnostics, and remote monitoring, individuals with personal experience with the specific change and individuals with >5 years’ professional experience were numerically more likely to recommend continuing the adjustment, and these differences were significant for telehealth (P=.04) and therapy shipment (P=.02). Conclusions: Clinical research professionals perceive that COVID-19–related clinical trial adjustments positively impact multiple aspects of study conduct. Those with greatest experience—both specific to COVID-19–related changes and more generally—are more likely to recommend that these adjustments continue in the future.

Improving the efficiency and effectiveness of clinical research regulatory review processes: Lessons from the Six Sigma Body of Knowledge

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e17554-e17554
Author(s):  
D. C. Stahl ◽  
C. J. Song ◽  
R. A. Figlin
Keyword(s):  
Adverse Events ◽  
Clinical Research ◽  
Process Improvement ◽  
Six Sigma ◽  
Review Process ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Regulatory Review ◽  
Efficiency And Effectiveness ◽  
The Impact

e17554 Background: The duration and complexity of regulatory review processes are increasingly associated with the slow pace and high cost of clinical trials. To evaluate and minimize the impact of these factors, City of Hope (COH), a NCI-designated Comprehensive Cancer Center, developed a strategic initiative to improve the efficiency and effectiveness of its clinical research review processes. The ongoing initiative is supported by Six Sigma-based techniques for problem identification and process optimization that have been successfully applied in other industries. Methods: The Six Sigma process improvement methodology known as DMAIC (Define, Measure, Analyze, Improve, and Control) was applied to five different clinical trial submission types (new study submissions, amendments, continuations, internal adverse events, external adverse events) reviewed by the COH Institutional Review Board (IRB), Cancer Protocol Review and Monitoring Committee (CPRMC), and Data and Safety Monitoring Board (DSMB). A consistent set of metrics and expectations were created for each review process to evaluate pre-review queue times, review process durations, submissions returned for corrections, and submissions returned with conditional approvals. Results: Over 7,900 submissions received during a 15 month period were evaluated quarterly to identify opportunities for improvement and the effects of previously implemented solutions. Multiple root causes for submission defects and delays were identified, including: (1) staffing and training deficiencies, (2) suboptimal workload distribution, (3) unclear policies and processes, (4) submission standardization opportunities, and (5) workflow automation and other information technology opportunities. Ongoing remediation efforts have yielded substantial improvements. Conclusions: Although Six Sigma process improvement techniques were originally developed for manufacturing applications, they can be applied in a clinical research setting to improve regulatory review processes. The methodology was most effectively introduced incrementally via application to specific problems rather than a traditional top-down implementation. Support provided by NCI P30 CA33572. No significant financial relationships to disclose.

scholarly journals Cancer Center Clinic and Research Team Perceptions of Identity and Interactions

2017 ◽  
Vol 13 (12) ◽  
pp. e1021-e1029 ◽  
Author(s):  
Torsten Reimer ◽  
Simon J. Craddock Lee ◽  
Sandra Garcia ◽  
Mary Gill ◽  
Tobi Duncan ◽  
...  
Keyword(s):  
Group Dynamics ◽  
The Other ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Research Staff ◽  
Research Teams ◽  
Team Members ◽  
Clinic Staff ◽  
Impact Function ◽  
Shared Information

Purpose: Conduct of cancer clinical trials requires coordination and cooperation among research and clinic teams. Diffusion of and confusion about responsibility may occur if team members’ perceptions of roles and objectives do not align. These factors are critical to the success of cancer centers but are poorly studied. Methods: We developed a survey adapting components of the Adapted Team Climate Inventory, Measure of Team Identification, and Measure of In-Group Bias. Surveys were administered to research and clinic staff at a National Cancer Institute–designated comprehensive cancer center. Data were analyzed using descriptive statistics, t tests, and analyses of variance. Results: Responses were received from 105 staff (clinic, n = 55; research, n = 50; 61% response rate). Compared with clinic staff, research staff identified more strongly with their own group ( P < .01) but less strongly with the overall cancer center ( P = .02). Both clinic staff and research staff viewed their own group’s goals as clearer than those of the other group ( P < .01) and felt that members of their groups interacted and shared information within ( P < .01) and across ( P < .01) groups more than the other group did. Research staff perceived daily outcomes as more important than did clinic staff ( P = .05), specifically research-related outcomes ( P = .07). Conclusion: Although there are many similarities between clinic and research teams, we also identified key differences, including perceptions of goal clarity and sharing, understanding and alignment with cancer center goals, and importance of outcomes. Future studies should examine how variation in perceptions and group dynamics between clinic and research teams may impact function and processes of cancer care.

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

2021 ◽  
pp. OP.21.00120
Author(s):  
Jennifer S. Mascaro ◽  
Patricia K. Palmer ◽  
Marcia J. Ash ◽  
Caroline Peacock ◽  
Anuja Sharma ◽  
...  
Keyword(s):  
Clinical Research ◽  
Well Being ◽  
Self Report ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Clinical Research Coordinator ◽  
Individual Resilience ◽  
Clinical Research Coordinators ◽  
Research Coordinator ◽  
The Impact

PURPOSE: Oncology clinical research coordinators (CRCs) and team-based coordinator care are critical for the success of clinical trials. However, CRCs typically report elevated anxiety and burnout and many oncology centers have high levels of coordinator attrition. To address the need for a team-based intervention to reduce burnout and promote resilience and cohesion among CRCs, we developed a compassion-centered, team-based intervention, Compassion-Centered Spiritual Health Team Intervention (CCSH-TI). METHODS: Participants were CRCs working in disease-specific teams within a comprehensive cancer center. CRCs were randomly assigned by team to either participate in four 60-minute sessions of CCSH-TI or receive the intervention after the study. To evaluate whether CCSH-TI is feasible and acceptable, we used a mixed-method approach including self-report questionnaires and a focus group. To evaluate the impact of CCSH-TI, we assessed self-reported resilience, well-being, burnout, and team civility before and immediately after the intervention period (ClinicalTrials.gov identifier: NCT04060901 ). RESULTS: Attendance varied by team, but all teams had rates more than 60%. Coordinators rated high levels of credibility of CCSH-TI to improve burnout, and the majority reported that they received benefits, particularly in resilience and stress management, indicating acceptability. Coordinators randomly assigned to CCSH-TI reported an increase in resilience compared with coordinators randomly assigned to the wait-list group (F(41) = 4.53, P = .039). CONCLUSION: Data from this pilot study indicate that CCSH-TI may be a feasible, credible, acceptable, and effective intervention to augment individual resilience among CRCs. However, the quantitative and qualitative data suggest that more comprehensive and systematic programming is necessary to truly mitigate burnout.

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