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.

Applying quality improvement methodologies to decrease the time-to-activation of new clinical trials at an NCI-designated comprehensive cancer center.

2019 ◽  
Vol 37 (27_suppl) ◽  
pp. 296-296
Author(s):  
Timothy J Brown ◽  
Erin Fenske Williams ◽  
Patrice Griffith ◽  
Asal Shoushtari Rahimi ◽  
Rhonda Oilepo ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Quality Improvement ◽  
Six Sigma ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Process Map ◽  
Decision Points ◽  
Improvement Methodologies ◽  
Six Sigma Methodology ◽  
Pass Through

296 Background: Initiating a new clinical trial is burdensome and complex. The time to activate a clinical trial can directly affect the ability to provide innovative, 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 from packet receipt to enrollment of the first patient. We applied classical QI and Six Sigma methodology to determine bottlenecks and redundancies in activating a clinical trial. During this process, particular attention was paid to time to pass through each step and perceived barriers and bottlenecks were identified through group discussions. The time to activation was measured from the day the trial packet was received until the time when the trial was open for enrollment. Results: The process map identified 66 steps with 12 decision points to activate a new clinical trial. The following two steps were instituted first: 1) allow parallel scientific committee and institutional review board (IRB) review and 2) allow the clinical research coordination committee to review protocols for feasibility and university interest separate from the IRB approval process. These changes resulted in a mean time-to-activation change from 194 days at baseline to 135 days after these changes were implemented. The committee continues to track the activation time and this frame work is used to identify additional improvement steps. Conclusions: By applying quality improvement methodologies and Six Sigma principles, we were able to redesign redundant aspects of the process of activating a clinical trial at a matrix comprehensive cancer center. This was associated with a reduction of time to activation of trials. More importantly, the process map provides a framework to maintain these gains and implement further changes.

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 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

scholarly journals Challenges to National Cancer Institute–Supported Cooperative Group Clinical Trial Participation: An ASCO Survey of Cooperative Group Sites

2010 ◽  
Vol 6 (3) ◽  
pp. 114-117 ◽  
Author(s):  
Allison R. Baer ◽  
Chelsey A. Kelly ◽  
Suanna S. Bruinooge ◽  
Carolyn D. Runowicz ◽  
Douglas W. Blayney
Keyword(s):  
Clinical Trial ◽  
Clinical Research ◽  
National Cancer Institute ◽  
Trial Participation ◽  
Cooperative Group ◽  
Clinical Trial Participation ◽  
Anecdotal Information

Anecdotal information regarding clinical research sites limiting participation in NCI-funded cooperative group studies prompted ASCO to collect data on and investigate the reasons behind this trend.

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