It is every research site’s biggest concern. The National Cancer Institute (NCI), the FDA, or drug company sponsors could arrive at any time to comb through a site’s documents related to a specific trial.
It’s called an audit, and it’s common.
And yet, not all sites that conduct research have proactive quality assurance initiatives in place to keep them audit-ready. Many, it turns out, are just not sure how to develop and launch an internal quality assessment program. Or they feel they don’t have the time or resources.
Enter ASCO’s Community Research Forum, a new initiative born out of ASCO’s Board of Directors’ Clinical Trial Strategic Plan of 2010. The Forum’s mission is to tackle key challenges faced by community sites involved in research.
For its first meeting, Forum leaders placed a heavy emphasis on developing a program that would equip all types of community sites for the quality assessment of a variety of research programs.
Quality Assurance Manual
The meeting agenda included a representative from the NCI who told attendees what the agency scrutinizes when auditing a clinical research site, including how variations are scored and what those scores mean.
“That really helped define the need for maintaining a quality program in your clinical research program,” said Thomas A. Marsland, MD, MPH, a medical oncologist practicing at the Cancer Specialists of North Florida, who leads the ASCO workgroup developing a manual to help community research sites develop a quality assurance program. The workgroup plans to complete the manual by next year’s meeting.
Attendees at this year’s meeting discussed the possibility of a research component being added to ASCO’s Quality Oncology Practice Initiative (QOPI®) program, a quality measurement and improvement program for practices.
Workload Assessment Tool Being Developed
A second key focus of the Forum in the coming year is completing the development of an online workload assessment tool. Once complete, this instrument will allow community practices to ascertain the clinical workload associated with individual trials. Developing a “formula” for workload is currently a challenging problem, as clinical trials can range from relatively simple and quick to extremely complicated and time-consuming for staff.
Judging workload simply by the number of patients recruited—a typical method—is a highly flawed approach, said Marge Good, RN, BSN, MPH, a nurse consultant in the NCI Division of Cancer Prevention and the leader of the ASCO workgroup developing the workload assessment tool.
“Practices have staff that often come to the manager and say, ‘We’re so busy, we’re dying.’ But there’s really no metric for practice managers to compare what their staff is doing with what other practices’ staffs are doing, and say, ‘Yes you are,’ or ‘No, you’re not,’” said Ms. Good.
At the meeting, attendees discussed workload issues and considered a number of workload assessment tools. They concluded that the tool developed by Ms. Good in her many years as Administrative Director of Wichita Community Clinical Oncology Program was the most practical and meaningful.
Ms. Good explained that the tool is a simple, easy-to-use system that she utilized to collect 10 years of data on trial acuity. From these data, practice leaders were better able to observe how staff members were using their time and to subsequently balance workloads and hire appropriate staff for the research protocols they were maintaining.
The workload assessment group plans to launch a pilot of the tool with many community practices in spring 2013 and present the tool at next year’s Forum meeting.
New Projects to be Launched at Next Year’s Meeting
The overall goal of the Forum is to produce helpful tools that will keep research quality high and assist community sites engaged in research. In the coming year the Community Research Forum Planning Committee will discuss additional project concepts that address cross-cutting challenges to conducting research in the community setting. The Forum will initiate projects to address these challenges at the 2013 meeting.
After all, said Dr. Marsland, with health-care reform upon us—not to mention multiple market-driven changes in research—ASCO wants to be at the forefront of the drive for quality.
“It’s important that ASCO define quality and become the voice for quality that is heard loud and clear,” he said. “This role is valid for research and ties in well with ASCO’s many activities and initiatives to promote quality across the whole spectrum of cancer care.” ■
© 2013. American Society of Clinical Oncology. All rights reserved.