Aims of a Community-Based Research Program

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.

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

Journal of Clinical Oncology ◽

10.1200/jco.2014.32.30_suppl.97 ◽

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.

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Dissemination Using Infographic Reports Depicting Program Impact of a Community-Based Research Program: eB4CAST in iCook 4-H

Journal of Nutrition Education and Behavior ◽

10.1016/j.jneb.2018.10.013 ◽

2019 ◽

Vol 51 (3) ◽

pp. S52-S59 ◽

Cited By ~ 5

Author(s):

Melissa D. Olfert ◽

Rebecca L. Hagedorn ◽

Makenzie L. Barr ◽

Sarah E. Colby ◽

Kendra K. Kattelmann ◽

...

Keyword(s):

Research Program ◽

Community Based ◽

Community Based Research ◽

Program Impact

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

Journal of Oncology Practice ◽

10.1200/jop.2015.008920 ◽

2016 ◽

Vol 12 (5) ◽

pp. e536-e547 ◽

Cited By ~ 6

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.

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