Each year, the Research Community Forum Council selects topic areas and specific solution-oriented projects to help overcome challenges related to conducting clinical research. Task Forces 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.
ICYMI: FDA Audit Readiness 2-Part Webinar
The ASCO RCF held a 2-part webinar on FDA Audit Readiness on February 13, and March 10, 2020 which shared experiences from the FDA, a principal investigator, and research staff to make FDA inspections less daunting. During part 1, James Reeves, MD from Florida Cancer Specialists and Yang-min Ning, MD from FDA shared insights into site selection and the investigator role in the audit process. Part 2 featured Andrea Buchmeier from Sarah Cannon, Katie Goodman from Florida Cancer Specialists, and Dr. Ning sharing strategies for effective pre-audit preparation and post-audit follow-up. Stay tuned for updates, including the webinar recordings. Do you have more questions about the FDA audit process or ideas for future webinars? Email us!
ICYMI: Joint ONS-ASCO RCF Webinar: Offering Clinical Trials can Make a Difference: Patient and care team perspectives
The Oncology Nursing Society and the ASCO RCF held a joint webinar on December 11, 2019. In this free webinar, a cancer survivor, community oncologist, and research nurse shared their perspectives on the benefits and challenges of being involved in clinical trials, especially in the community setting. They offered practical strategies and resources to ensure clinical trial access and participation, including how to effectively discuss clinical trials with your patients and colleagues. Visit the ONS website to access the webinar recording.
ASCO Adverse Events Reporting Decision Aid Toolkit
As part of ASCO’s educational efforts aimed at improving the quality, relevance, and efficiency of serious adverse events (SAE) reporting, a Task Force developed the ASCO Adverse Event Reporting Decision Aid Toolkit. Guidance provided in the Decision Aid and Toolkit is based on existing U.S. Food and Drug Administration regulations.
The ASCO Adverse Events Reporting Decision Aid is intended to assist physician investigators and research staff in determining whether an adverse event (AE) should be: (i) reported to the sponsor as a serious AE (SAE) and (ii) attributed to the investigational drug. The Decision Aid is intended to be a general guide for deciding whether an adverse event is caused by an investigational drug. These decisions ultimately require clinical judgment to determine if there is a reasonable possibility that the drug caused the event. The Decision Aid can be accessed here as a .pdf file.
The ASCO Adverse Events Reporting Toolkit contains the Decision Aid, sample clinical case studies and answers, and additional references. It is intended for use as an educational resource about SAE reporting by physician-investigators and research staff to sponsors of investigational new drug (IND) studies. Please complete the brief request form for access to the Toolkit.
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As part of its efforts to develop practical resources for sites, the ASCO RCF has developed At-a-Glance summaries that offer key best practices, tips, and considerations on topics related to conducting and managing clinical trials. Each At-a-Glance summary also includes a list of helpful resources to provide resources and further information on each topic. Access the summaries from the Clinical Trial Resources library.
ASCO RCF Online Forum
Interested in connecting with colleagues? Join the ASCO RCF online forum through ASCO’s myConnection. The online forum offers the research community a venue for members to engage with the research community and network, share best practices, access resources, and learn more about the ASCO RCF and its initiatives. The online forum features discussion boards, a resource library, and other features to connect online forum members. Note: access to the online forum requires an asco.org account, which is free and easy to create.
RCF Toolkit of Resources
The RCF has developed toolkits offering helpful resources, templates, and forms to help research sites overcome selected barriers to conducting and managing clinical trials. Complete a brief request form for access to each toolkit of resources.
- FDA Audit Readiness (2019) - offers resources related to FDA audits and audit readiness
- The Business of Clinical Trials (2018) - offers resources to assist research sites with clinical trial operations and building an effective research program
- Insurance Coverage of Clinical Trials (2017) - offers resources to help research sites effectively determine insurance coverage of clinical trials, dealing with coverage denials, and navigating the appeals process
These toolkits will be periodically updated. If you have ideas for resources to add to the toolkit, please email RCF staff.
Insurance Coverage of Clinical Trials
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, which was held August 6-7, 2015, was to provide stakeholders with the knowledge, skills, and tools needed to complete a centralized coverage analysis. 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.
Please complete the request form for access to the tool.
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.
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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.