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
2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e24135-e24135
Author(s):  
Angelique Wong ◽  
Frank V. Fossella ◽  
George R. Simon ◽  
Rama Maddi ◽  
Zhanni Lu ◽  
...  

e24135 Background: Current ASCO guidelines propose early access to SC in all CP to improve quality of care, quality of life, and symptoms. Very few studies have evaluated patients’ perceived criteria for referral to outpatient SC and perceptions of patients who are referred early in their disease trajectory. Methods: In this study we evaluated CP attitudes and perceptions regarding the role of and access to outpatient Supportive Care clinic (SCC) at a comprehensive cancer center. CP with life expectancy of greater than 6 months (as determined by the oncologist) and who are newly registered at MD Anderson Cancer Center were randomized to either obtain an educational brochure that explained the role of the SCC or no brochure. Both groups then completed a survey regarding the role and access to of outpatient SCC. After completion of the survey, patients were asked if they would like to be seen by the SC team. If so, they were scheduled by their oncologist for a SC consult. Results: 288 patients were evaluable: median age was 63, 43% were female, 84% were Caucasian, and the most common cancer type was lung cancer (39%). Median survival was 15 months. Patients who received a brochure reported more understanding of the role of SC vs those who did not receive a brochure (63% vs 37%, p = 0.04). Both groups felt that SC could help to address physical (47% vs 54%) and psychosocial (50% vs 50%) symptoms. Both groups felt SC could help to address questions regarding prognosis (50% vs 50%) and future care (53% vs 47%). Both groups did not feel that time (50% vs 50%) nor financial concerns (49% vs 51%) would be barriers to access SC. Both groups did not feel that receiving SC would impede their cancer care (60% vs 40%) nor change their oncologists’ perspective of them (25% vs 75%). Both groups felt they could receive SC and cancer care simultaneously (50% vs 50%). Approximately half of the patients in both groups perceived it was not too early for a referral to SC. There were no statistical differences in these groups for these findings. Conclusions: Patients who received a brochure had a better understanding of the role of SC. A very significant proportion in both groups had limited awareness of the value of SC. Oncologist driven referral and education of SC may facilitate better understanding of the value of SC. Further studies are needed.


2020 ◽  
Vol 16 (4) ◽  
pp. e324-e332 ◽  
Author(s):  
Erin Williams ◽  
Timothy J. Brown ◽  
Patrice Griffith ◽  
Asal Rahimi ◽  
Rhonda Oilepo ◽  
...  

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.


2016 ◽  
Vol 34 (15_suppl) ◽  
pp. e18267-e18267
Author(s):  
Erin Fenske Williams ◽  
Joan H. Schiller ◽  
Joyce D Bolluyt ◽  
David E. Gerber

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 1266-1266
Author(s):  
Bayard L. Powell ◽  
Debbie Olson ◽  
Robert M. Morrell ◽  
Terry L. Hales ◽  
Kevin P High ◽  
...  

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.


2017 ◽  
Vol 24 (8) ◽  
pp. 2387-2396 ◽  
Author(s):  
Jennifer L. Miller-Ocuin ◽  
Mazen S. Zenati ◽  
Lee M. Ocuin ◽  
Patrick R. Varley ◽  
Stephanie M. Novak ◽  
...  

2011 ◽  
Vol 9 (11) ◽  
pp. 1228-1233 ◽  
Author(s):  
Pam James ◽  
Patty Bebee ◽  
Linda Beekman ◽  
David Browning ◽  
Mathew Innes ◽  
...  

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.


1993 ◽  
Vol 23 (1) ◽  
pp. 15-44 ◽  
Author(s):  
Samuel S. Epstein

A statement by 68 prominent national experts in cancer prevention, carcinogenesis, epidemiology, and public health, released at a February 4, 1992, press conference in Washington, D.C., charged that the National Cancer Institute (NCI) has misled and confused the public by repeated claims of winning the war against cancer. In fact, age-standardized incidence rates have escalated to epidemic proportions over recent decades, while the ability to treat and cure most cancers has not materially improved. Furthermore, the NCI has minimized evidence for increasing cancer rates, which are largely attributed to smoking, trivializing the importance of occupational carcinogens as non-smoking attributable causes of lung and other cancers, and to diet per se, in spite of tenuous and inconsistent evidence and ignoring the important role of carcinogenic dietary contaminants. Reflecting this near exclusionary blame-the-victim theory of cancer causation, with lockstep support from the American Cancer Society and industry, the NCI discounts the role of avoidable involuntary exposures to industrial carcinogens in air, water, food, the home, and the workplace. The NCI has also failed to provide any scientific guidance to Congress and regulatory agencies on fundament principles of carcinogenesis and epidemiology, and on the critical needs to reduce avoidable exposures to environmental and occupational carcinogens. Analysis of the $2 billion NCI budget, in spite of fiscal and semantic manipulation, reveals minimal allocations for research on primary cancer prevention, and for occupational cancer, which receives only $19 million annually, 1 percent of NCI's total budget. Problems of professional mindsets in the NCI leadership, fixation on diagnosis, treatment, and basic research, much of questionable relevance, and the neglect of cancer prevention, are exemplified by the composition of the National Cancer Advisory Board. Contrary to the explicit mandate of the National Cancer Act, the Board is devoid of members authoritative in occupational and environmental carcinogenesis. These problems are further compounded by institutionalized conflicts of interest reflected in the composition of past executive President's Cancer Panels, and of the current Board of Overseers of the Sloan-Kettering Memorial Cancer Center, the NCI's prototype comprehensive cancer center, with their closely interlocking financial interests with the cancer drug and other industries. Drastic reforms of NCI policies and priorities are long overdue. Implementation of such reforms is, however, unlikely in the absence of further support from industrial medicine professionals, besides action by Congress and concerned citizen groups.


2021 ◽  
Vol 19 (5) ◽  
pp. 505-512
Author(s):  
David E. Gerber ◽  
Thomas Y. Sheffield ◽  
M. Shaalan Beg ◽  
Erin L. Williams ◽  
Valerie L. Clark ◽  
...  

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.


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