By Beverly Ginsburg Cooper, MBA, Senior Vice President, Research, Dana-Farber Cancer Institute, Associate Director, Administration, Dana-Farber/Harvard Cancer Center; Alyssa Gateman, MPH, CCRP, Director, Quality Assurance Office for Clinical Trials, Dana-Farber/Harvard Cancer Center; Bryan Peterson, CCRP, Regulatory Affairs Specialist, Quality Assurance Office for Clinical Trials, Dana-Farber/Harvard Cancer Center
In May, representatives from the Harvard Cancer Center/Dana-Farber Cancer Institute presented on their strategies for conducting multi-center trials during a webinar hosted by Forte Research Systems.
The presentation touched upon operations within the HCC/DFCI formal consortium, as well with unaffiliated sites. They received many questions from attendees of the webinar, and these are their responses.
Question 1: How do you finance monitoring and auditing?
Answer: Our auditors are funded by DF/HCC. The funding for monitors is a combination of Cancer Center Support Grant (CCSG) and institutional sources. Faculty are encouraged, however, to secure external funding for specific trials whenever possible, especially for complex, large trials.
Some of our institutional sites cover the salaries of monitors. At other sites, the disease teams are responsible for the cost. The approach depends on which group (institution vs. PI) receives the income stream related to trials.
Q 2: How do you staff your auditing and monitoring functions?
A: DF/HCC has a dedicated team that conducts audits of trials on behalf of our entire consortium. There are no institutionally based auditors for cancer protocols.
Monitoring is the responsibility of the PI and home institution. They may use internal monitoring staff to meet their obligation or contract with a CRO, which may be helpful for large, complex studies with national and international sites.
Some of our institutions have a centralized group of monitors. At other sites, monitors are embedded within the disease team.
At Dana-Farber, we historically have had a decentralized monitoring model and, thus, monitors were spread among disease groups. We recently created a monitoring service in our clinical trials office so that investigators can hire experienced monitors by the hour/function rather than incurring the cost of full-time staff when they require such a resource throughout the life of a study. This approach is catching on, and should grow significantly in the coming year.
Q 3: Do you have the protocol reviewed at DF/HCC before it is issued to external sites?
A: Yes, we require that the protocol be approved by our IRB before being sent to external sites for review by their local IRB. This eliminates the risk of having multiple versions of the protocol in circulation.
Q 4: How do you document protocol and amendment training at sites?
A: Documentation of training is the responsibility of the sponsor team. Each sponsor team manages the sponsor file for all participating sites. Individual sites also maintain regulatory files related to their participation.
Q 5: How do you assess the qualifications of an unaffiliated site?
A: All prospective sites are required to complete a Site Selection and Feasibility Questionnaire. Our team developed this form several years ago to make this process as streamlined and organized as possible. It focuses on the site’s overall capabilities, track record in conducting trials and current resources. The goal is to assess the sites recruitment potential, resources, and ability to meet the specific requirement of the protocol. We also request the CV of the responsible investigator for the site.
It is the ultimate responsibility of the investigator sponsor to determine the prospective sites’ ability to comply with the protocol. However, our Multi-Center Coordinating Committee is charged with reviewing all sponsor-selected sites before the site is approved to participate in the protocol.
Q 6: Do you perform central registration for subjects accrued at unaffiliated sites?
A: Yes, we do. We hold the sponsor team responsible for ensuring that only eligible participants are enrolled. The external site will send a completed eligibility checklist and signed consent form to the sponsor team, along with source documentation confirming this information. The sponsor team verifies eligibility and then completes the central registration process with the DF/HCC Quality Assurance of Clinical Trials Office. During monitoring visits, the monitor may also verify all points of eligibility.
For Part 2 of the Q&A, visit the article “Managing Multi-Center Trials in Clinical Research — Q&A (Part 2).”