scholarly journals Assessing Clinical Trial–Associated Workload in Community-Based Research Programs Using the ASCO Clinical Trial Workload Assessment Tool

2016 ◽  
Vol 12 (5) ◽  
pp. e536-e547 ◽  
Author(s):  
Marjorie J. Good ◽  
Patricia Hurley ◽  
Kaitlin M. Woo ◽  
Connie Szczepanek ◽  
Teresa Stewart ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Research ◽  
Research Program ◽  
Assessment Tool ◽  
Cancer Control ◽  
Community Based ◽  
Community Based Research ◽  
Research Programs ◽  
Number Of Patients ◽  
Clinical Trial Accrual

Purpose: Clinical research program managers are regularly faced with the quandary of determining how much of a workload research staff members can manage while they balance clinical practice and still achieve clinical trial accrual goals, maintain data quality and protocol compliance, and stay within budget. A tool was developed to measure clinical trial–associated workload, to apply objective metrics toward documentation of work, and to provide clearer insight to better meet clinical research program challenges and aid in balancing staff workloads. A project was conducted to assess the feasibility and utility of using this tool in diverse research settings. Methods: Community-based research programs were recruited to collect and enter clinical trial–associated monthly workload data into a web-based tool for 6 consecutive months. Descriptive statistics were computed for self-reported program characteristics and workload data, including staff acuity scores and number of patient encounters. Results: Fifty-one research programs that represented 30 states participated. Median staff acuity scores were highest for staff with patients enrolled in studies and receiving treatment, relative to staff with patients in follow-up status. Treatment trials typically resulted in higher median staff acuity, relative to cancer control, observational/registry, and prevention trials. Industry trials exhibited higher median staff acuity scores than trials sponsored by the National Institutes of Health/National Cancer Institute, academic institutions, or others. Conclusion: The results from this project demonstrate that trial-specific acuity measurement is a better measure of workload than simply counting the number of patients. The tool was shown to be feasible and useable in diverse community-based research settings.

Critical Aspects of a Sustainable Clinical Research Program in the Community-Based Oncology Practice

2019 ◽  
pp. 176-184 ◽  
Author(s):  
Jennifer L. Ersek ◽  
Stephanie L. Graff ◽  
Francis P. Arena ◽  
Neelima Denduluri ◽  
Edward S. Kim
Keyword(s):  
Clinical Research ◽  
Patient Care ◽  
Health Care Providers ◽  
Research Program ◽  
Improve Patient Care ◽  
Care Providers ◽  
Community Based ◽  
Technological Infrastructure ◽  
Community Based Research ◽  
Research Programs

Increasing enrollment into clinical trials is a top priority across the field of oncology. Because the vast majority of those afflicted with cancer receive their care in the community, creating strong clinical research programs in the community-based setting is important. This article comprehensively outlines the most important elements of creating and sustaining a successful community-based research program. Establishing a clear mission and defining the scope of the research program in collaboration with key physicians and administrative leadership are critical to success. Standard operating procedures should detail operational processes. Ensuring sound financial planning and protected physician time are crucial for a healthy program. Providing mentorship opportunities to investigators and other team members will provide necessary guidance for junior investigators and long-term program stability. Prioritizing provider and patient volunteer engagement through education and awareness will potentially improve enrollment and research ownership. Incorporating administrative and clinical research staff and health care providers, including physicians, advanced practice providers, and pharmacists, will result in a multidisciplinary and unified approach and may also promote research as a routine part of patient care. Regular safety and scientific meetings will reduce regulatory complications and, most importantly, improve patient care. Other keys to a successful program include establishing a diverse trial portfolio, collaboration between different institutions, and ensuring appropriate technological infrastructure. Serial programmatic review provides opportunities to refine suboptimal practices and recognize successful strategies. Community-based research programs are critical to improve access to optimal cancer care. Implementation of successful programs is possible with a collaborative and multidisciplinary approach.

scholarly journals ASCO's Community Research Forum: Addressing Challenges of Community-Based Research from the Grass Roots

2014 ◽  
pp. e111-e115
Author(s):  
Nicholas Robert ◽  
Rogerio Lilenbaum ◽  
Patricia Hurley
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Assessment Tool ◽  
Community Research ◽  
Trial Participation ◽  
Community Based ◽  
Community Based Research ◽  
Research Programs ◽  
Clinical Research Associates ◽  
Conducting Research

ASCO's Community Research Forum is a solution-oriented venue for community research sites to overcome barriers to conducting clinical trials. The key objectives of the Forum are to (1) convene community-based researchers to identify challenges to conducting research that ASCO can address, (2) develop solution-oriented projects to address these challenges to facilitate clinical trial participation in community research settings, and (3) shape ASCO programs and policies to support members engaged in community research. The Community Research Forum holds an annual in-person meeting that convenes physician investigators, research administrators, research nurses, and clinical research associates from community-based research programs and practices. To meet identified needs, the Community Research Forum has developed the ASCO Clinical Trial Workload Assessment Tool and the ASCO Research Program Quality Assessment Tool. Both of these tools will be available to the public in 2014. The Forum is currently exploring the concept and potential metrics of a research certification program to formally assess community-based research programs, and to identify gaps and areas to improve the program in order to meet quality standards. The Community Research Forum's website aims to serve as a go-to resource for community-based physician investigators and research staff. The Community Research Forum will continue to provide a forum for community-based researchers to network, share challenges, and develop initiatives that provide solutions and facilitate the conduct of clinical trials.

ASCO research program quality assessment tool: Basics for a quality community-based research site.

2014 ◽  
Vol 32 (30_suppl) ◽  
pp. 97-97
Author(s):  
Patricia A. Hurley ◽  
Renee Yvonne Smith ◽  
Nicholas J. Robert
Keyword(s):  
Quality Assurance ◽  
Quality Assessment ◽  
Research Program ◽  
Quality Assurance Program ◽  
Internal Quality ◽  
Community Based ◽  
Community Based Research ◽  
Minimum Standards ◽  
Research Programs ◽  
Internal Quality Assurance

97 Background: In 2008, ASCO published a statement to identify minimum standards and exemplary attributes of clinical trial sites. Recommendations were made to assist with the development and implementation of high-quality research programs. Based on feedback from an ASCO needs assessment survey, ASCO’s Community Research Forum (CRF) sought to develop a tool to help community-based research sites exceed the minimum standards of conducting clinical research, and to identify important components for an internal quality assurance program. Methods: A tool was developed to incorporate elements of ASCO publications on minimal standards and exemplary attributes of research sites. The tool was designed to assist community-based research sites with the development and implementation of an internal quality assurance program. A checklist was also developed to help sites easily conduct an assessment of their program. Community-based researchers provided feedback on the tool’s content and utilization. Feedback was incorporated and the tool was released for widespread use in March 2014. Results: The tool was very well received by reviewers. All reviewers indicated that the level of detail of the tool was sufficient; 94% indicated that it presented realistic expectations, in terms of resources required to implement; and 81% indicated that it would be valuable for conducting a quality assessment of their research program. As of July 2014, the tool was downloaded by over 150 practices from 8 different countries and early feedback continued to be favorable, particularly from small and/or new research programs. Conclusions: Many community-based research programs do not have the resources to support an effective quality assurance program and rely heavily on external audits. The ASCO Research Program Quality Assessment Tool provides self-directed continual process improvement to help community-based research sites create an internal quality assurance program and exceed minimum standards of conducting clinical research. The CRF will learn more from users of the tool about the quality of research programs and processes, and key quality metrics. The tool is available for download at www.asco.org/communityresearchforum.

A novel approach to support community oncology practices in building a clinical research program.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e18087-e18087
Author(s):  
Jeremy Miller ◽  
Debra A. Kientop ◽  
Linda Andrews ◽  
William Jeffery Edenfield ◽  
David Hadley
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Research Program ◽  
Professional Services ◽  
Novel Approach ◽  
Community Oncology ◽  
Number Of Patients ◽  
Clinical Trial Enrollment ◽  
Building Program

e18087 Background: Starting a clinical research program in a community oncology setting has a myriad of challenges. While ASCO provides guidance through its “Basic Requirements for Starting a Research Practice”, building a research program requires significant time and effort. We present an example of how a technology-enabled solution supports a consortium of community oncology practices to rapidly grow their clinical research program, as they strive to meet the Commission on Cancer goal of > 4% clinical trial enrollment. Methods: Four key pillars that support a successful research program include: building program infrastructure, establishing standard operating procedures, engaging patients and accessing clinical trials. The consortium receives support for each of these components through a combination of software tools and professional services. Results: The practices in the consortium currently have clinical trial enrollment that is less than desired, but the number of patients on clinical trials in the consortium for coming year is expected to grow between two and ten-fold. The table below shows the enrollment by site in 2018 for the 7 practices that have been engaged for the full year. Candidates are patients who have found to be eligible for at least one clinical trial, but have not yet been enrolled or declined. Conclusions: The practices have been engaged in the consortium for approximately one year. While some practices are well below their eventual target of 4% enrollement, the increasing number of patients screened, and their growing clinical trial portfolio of well-matched clinical trials has them well on their way to that target over the next two years.[Table: see text]

Removing barriers to clinical research in community hospitals—The Fox Chase Cancer Center Partners experience

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 6614-6614 ◽  
Author(s):  
M. A. O'Grady ◽  
S. J. Cohen ◽  
P. A. Keeley ◽  
E. Sein ◽  
B. J. Miller ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Median Number ◽  
Cancer Center ◽  
Community Hospitals ◽  
Research Programs ◽  
Regulatory Burden ◽  
Clinical Trial Accrual ◽  
Research Nurses

6614 Background: Although the majority of cancer patients are treated in community hospitals, resources to support community clinical trials are often limited. The Fox Chase Cancer Center Partners (FCCCP) initiative is a large academic and community based oncology program in the Delaware Valley. We hypothesized that a detailed clinical research assessment within the 18 main community cancer research programs of the FCCCP would result in improved clinical trial accrual. Methods: The FCCCP clinical team completed research assessments at 10 affiliated community hospitals during 2004–2006 to evaluate active trials, research nurses and data managers, and research barriers. Institutions were benchmarked for staffing, processes, outreach, and quality improvement. Results were presented to administration at each hospital and impact on research accrual recorded. Results: In 2004, 371 patients were treated on clinical trials at 18 FCCCP community research programs. The median number of data managers, research nurses, and open protocols per site was 0.7, 1.6 and 48 respectively. The most common perceived barriers to accrual by investigators and research staff were regulatory burden, time, and awareness. Recommendations included: improved tumor registry identification of clinical trial candidates, increased staffing, improved web-based outreach, and targeted research affiliations. With regulatory burden a significant research barrier, the following IRB streamlining processes were recommended: NCI Central IRB, for-profit IRBs, IRB reciprocity, and centralized health system IRBs. With implementation of recommendations, 10/18 IRBs have transferred to the NCI-Central IRB for phase III cooperative group studies. The median number of data managers and research nurses per site increased to 1.25 and 1.7 respectively. Although the median number of open trials per site remained at 48, accruals to clinical trials increased to 805, representing a 116% increase. Conclusions: Research assessments are feasible in a large academic-community hospital partnership program and result in best practice recommendations with increased clinical trial accrual. Larger scale implementation of research infrastructure in community oncology programs is warranted. No significant financial relationships to disclose.

Barriers to Clinical Trial Accrual: Perspectives of Community-Based Providers

2020 ◽  
Vol 20 (5) ◽  
pp. 395-401.e3
Author(s):  
Lauren P. Knelson ◽  
Anthony R. Cukras ◽  
Jennifer Savoie ◽  
Ankit Agarwal ◽  
Hao Guo ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Community Based ◽  
Clinical Trial Accrual

Cancer clinical trial accrual patterns among community cancer centers in the United States

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 6041-6041
Author(s):  
J. A. Lee ◽  
M. A. Mathiason ◽  
C. A. Czeczok ◽  
J. K. Keller ◽  
R. S. Go
Keyword(s):  
Clinical Trial ◽  
Data Management ◽  
Cancer Patients ◽  
The United States ◽  
Cooperative Groups ◽  
Medical Support ◽  
Cancer Centers ◽  
Number Of Patients ◽  
Clinical Trial Accrual ◽  
The U.S

6041 Background: Most cancer patients are diagnosed and treated in the community but clinical trial accrual rate is low. Published data on trial accrual from community-based cancer centers throughout the U.S. are limited. The Association of Community Cancer Centers (ACCC) is a national multidisciplinary education and advocacy organization that maintains a membership caring for over 60% of all patients with cancer in the U.S. In order to determine the clinical trial accrual patterns in the community across various geographic regions in the U.S., we performed a retrospective study utilizing the data from ACCC membership maintained at their web site. Methods: Data available from the most recent year (2003–2005) were obtained from 621 centers throughout the U.S., representing 49 states (no data for WY) and the DC. We investigated the number of patients (new and old) accrued into trials per year relative to the number of new analytical patients seen in the same year, a value we termed accrual ratio (AR). In addition, we studied the effects of geographic location, size of the cancer program, number of affiliations with National Cancer Institute sponsored cancer cooperative groups, and the number of medical/support/data management staffs on trial accrual. Results: A total of 670,215 new patients were seen across the ACCC membership with 43,743 patients accrued into trials for a median AR of 6.5% (range, 0.3–16.9). The top and bottom 5 accruing states were VT, MD, SD, LA, ID and KS, ND, VA, NH, AR, respectively. Regionally, the AR for Midwest, Middle Atlantic, West, South, Southwest, and New England were as follows: 7.4%, 7.0%, 6.2%, 6.0%, 5.7%, and 5.4% (p < 0.001). One hundred (16.1%) centers representing 11.8% of all new patients were not affiliated with any of the cooperative groups. This group had the lowest AR (3.1%). AR increased when centers were affiliated with more cooperative groups (p < 0.001) or cared for more new patients (p < 0.001). The number of medical, support, and data management staffs did not influence accrual. Conclusions: Overall, clinical trial accrual in the U.S. community cancer centers is low. Accrual patterns differed significantly among various geographic locations. Better access to trials is needed in order to improve participation of cancer patients. No significant financial relationships to disclose.

Tracking clinical trial accrual strategies and barriers via a Web-based screening tool

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 6586-6586 ◽  
Author(s):  
S. S. Grubbs ◽  
M. Gonzalez ◽  
M. Krasna ◽  
R. Siegel ◽  
D. Bryant ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Chronic Lymphocytic Leukemia ◽  
Cancer Control ◽  
Lymphocytic Leukemia ◽  
Trial Participation ◽  
Clinical Trial Participation ◽  
Web Based ◽  
Prior Therapy ◽  
Trial Entry ◽  
Clinical Trial Accrual

6586 Background: The National Cancer Institute Community Cancer Centers Program (NCCCP) has developed a web based tracking tool to monitor screening of patients for clinical trial participation. The system is designed to collect data from multiple research sites throughout the geographically diverse group. The log blindly collects patient demographics, successful trial entry, and reasons for trial enrollment failure. Methods: Seven NCCCP sites utilized the log during the 60 day open accrual period for the Wake Forrest WFU 07–02–03 cancer control trial (chronic lymphocytic leukemia COLD- fX) in Novermber 2008 and December 2008. Results: 327 chronic lymphocytic leukemia patients were screened mostly by chart review. 162 (50%) were eligible for study entry. 45 (14%) entered the trial. 103 (31%) eligible patients declined entry. Of the 103, 72 (70%) did not wish to participate in research, 15 (15%) had travel constraints, 5 (5%) perceived excess toxicity, 9 (9%) gave no reason. 14 (3%) eligible had their physician decline entry. Overall, 28% of eligible patients entered the trial. 165 (50%) were trial ineligible. 82 (50%) for prior therapy, 30 (18%) for co morbid conditions, 10 (6%) missed an entry time requirement, 39 (24%) have incomplete data. Conclusions: The NCCCP trial screening log successfully captures real time clinical trial participation data from a diverse network of clinical trial sites. This data base will allow future analysis of individual clinical trial and site accrual barriers and empower strategies to increase trial participation. No significant financial relationships to disclose.

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