Each year, the Research Community Forum Council selects topic areas and specific solution-oriented projects to help overcome challenges related to conducting clinical research. Working Groups are convened to advance these projects. The outcomes/work products are presented for feedback at annual Forum meetings and are made available to the research community through various ASCO venues. Descriptions of the key projects to date follow.
Insurance Coverage of Clinical Trials
The ASCO Insurance Coverage of Clinical Trials Toolkit was developed as part of an initiative led by the American Society of Clinical Oncology's Research Community Forum (ASCO RCF) to develop tools and resources to assist oncology research programs with conducting insurance coverage analyses for clinical trials.
An ASCO RCF Working Group, led by Connie Szczepanek, RN, BSN, conceived of this Toolkit during an earlier initiative on clinical trial coverage analyses. This Toolkit contains sample checklists, templates, and forms to assist research sites with effectively determining insurance coverage of clinical trials, dealing with coverage denials, and navigating the appeals process.
To access the Toolkit, please contact ASCO Research Community Forum staff.
Billing Compliance Solutions
Research sites had identified billing compliance and conducting an insurance coverage analysis prior to opening trials as major burdens. For large, multi-site clinical trials, each site was carrying out its own coverage analysis assessment, costing significant time and resources across the system. A Forum Working Group (led by Connie Szczepanek, RN, BSN) was formed in 2015 to identify and develop at least one tangible and impactful initiative that would help research sites address some of the billing compliance issues they encounter on a daily basis. The group developed a concept for a centralized coverage analysis, which would be conducted prior to opening a trial and then provided to participating sites.
The Working Group collaborated with National Cancer Institute (NCI) to provide a training symposium for key stakeholders. The goal of the symposium was to provide stakeholders with the knowledge, skills, and tools needed to complete a centralized coverage analysis.
- ASCO-NCI Training Symposium on Clinical Trial Coverage Analysis for Multi-Center Trials was held August 6 and 7, 2015 at ASCO headquarters, and included approximately 45 attendees from a range of stakeholder groups, including NCTN Groups, NCORP Research Bases, CMS, NCI CTEP, and NCI CTSU. A summary report that shares lessons learned regarding billing compliance and conducting coverage analysis has been published. This resource may be used by enterprises to develop centralized coverage analyses for their trials.
Research Contract Negotiation Resources
A Forum Working Group (led by Michael Thompson, MD, PhD) was formed in 2015 to identify and develop a resource to help research sites address barriers they encounter in the contract negotiations process. One hundred and fifty research programs responded to a survey to identify their pain points or barriers related to negotiating contracts and establish resources that could be developed to address these barriers. The Journal of Oncology Practice (JOP) published an article, "Challenges With Research Contract Negotiations in Community-Based Cancer Research," by Thompson, et al., summarizing the survey findings and identifying recommendations from the Forum.
Research Program Quality Assessment Initiatives
The ASCO Research Program Quality Assessment Tool has had over 250 downloads since its release in 2014. The tool is designed to help research sites establish or enhance their internal quality assessment program and exceed the minimum standards of conducting clinical research. The content of the tool draws from ASCO's statement on Minimal Standards and Exemplary Attributes of Clinical Trial Sites (Zon et al, JCO, 2008). The key quality domains include: General Research Program Administration; Program Management; Protocol Management; and Data Collection, Management, and Quality Control.
- Access a manual: The tool includes a manual that features a "how-to" guide for research sites. The manual also includes other helpful resources and templates.
- Conduct an assessment of your research program: The tool is a self-assessment that allows users to gauge whether their research program includes the important components of an internal quality assessment program, and to identify areas for improvement.
To access the tool, please contact ASCO Research Community Forum staff.
Clinical Trial-Associated Workload Solutions
Over 200 research programs from around the world have registered to use the ASCO Clinical Trial Workload Assessment Tool since its release in 2014. This user-friendly online tool aims to help research administrators assess clinical trial-associated workload based on the complexity of research protocols and the number of patients assigned to staff. The tool enables administrators to more effectively monitor and manage staff capacity, productivity, and needs. It also provides site-specific, individual staff-specific, and protocol-specific reports. The tool was developed by a Forum Working Group that was led by Marge Good, RN, MPH, OCN. The tool is available for free.
A pilot study with 51 research sites was conducted to assess the utility and feasibility of the Tool. A manuscript summarizing the findings was published in March 2016 (Good et al., JOP, 2016).
Online Resources for Research Sites
The Research Community Forum website aims to serve as a go-to resource for research sites, and provides helpful links to resources that facilitate the conduct and management of clinical trials, especially in the community setting. A Forum Working Group (led by Terri Stewart, MS, CRCP) compiled a list of helpful resources for research sites; the list is monitored periodically to ensure currency. This online library is organized by key topic areas related to conducting and managing clinical trials, including: basics for starting a research program, program administration, budget management, study start-up, management of trials and patients, data management, and quality assessment. These resources are available for free via the Clinical Trial Resources page. If you have any suggestions, or would like more information, please contact us by email.
The Research Community Forum continues to consider ideas for future initiatives that will provide solutions to challenges faced by research sites. Ideas are welcomed! Please email the Research Community Forum with any suggestions.