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Steps to take when starting a CT monitoring service
Experts offer advice on getting started
Starting a clinical trial monitoring service requires some time and financial resources, but it quickly become successful if certain steps are taken.
Two people involved in the groundwork that created the clinical trial monitoring service for investigator sponsor research at the University of Minnesota in Minneapolis, MN, explain how the program works:
• Design service to be free to sponsor investigators and to follow industry standards.
"We've focused on providing the monitoring service for free to faculty who serve as both sponsor and investigator as a first priority because the university has a responsibility to perform monitoring whenever an agent holds an IND," says Debra Dykhuis, CCRC, CCRA, associate director of the Research Services Organization, Academic Health Center of the University of Minnesota.
The entire monitoring program is based on good clinical practice (GCP) standards and not simply on specific regulations, she notes.
The monitoring service was formed within the past couple of years as part of the university's Research Services Organization (RSO), which helps investigators with writing protocols, budgets, and other aspects of research, says Harvey M. Arbit, PharmD, MBA, RAC, the IND/IDE assistance program director at the University of Minnesota.
• Staff office with professionals.
Administrators decided the monitoring service would need two full-time professional monitors.
"We had to figure out how to find people to do this job in an academic center, recognizing the fact that we cannot compete with CROs and local industry that employs people serving the exact function we needed," Dykhuis says.
"We posted our position with an ad that read, 'Do you love your work but are sick of the travel?'" Dykhuis says. "Since these jobs involve monitoring at a single site, people don't have to spend 30 to 60 percent of their time on the road."
Also, the salary was made competitive, she adds.
The positions quickly filled.
"One person we hired had gone to school at this university, and she was so excited about the fact that the university was acknowledging the importance of monitoring that she wanted to be a part of the new program," Dykhuis says.
"A lot of people know it's true that academic centers aren't as aware of or as proactive about doing this kind of thing as they might be, and she was excited about that aspect of it," she adds.
• Write a monitoring plan.
The next step was to write a monitoring plan that would be included with IND applications, Dykhuis says.
"Up to this point, people had included a plan with the IND, but it was a self-monitoring option," she says. "We still do offer that option for people here, where they can elect to use a plan we've written that would allow sponsor investigators to monitor themselves, although we don't recommend it."
The monitoring plan is well organized with 10 pages that cover these items:
Each category includes precise details of what will occur. For instance, under the scope of CTMS monitoring, the text reads, "In compliance with GCP guidelines, RSO monitors will verify data collected on case report forms against source documents. Source documents are defined as any original records or data related to the trial or to subject treatment or medical history. Source documents include: original hospital, clinical, and office charts, laboratory notes, subject diaries or evaluation checklists, pharmacy records, recorded data from automated instruments, transcriptions (certified to be accurate after verification), magnetic media, or x-rays..."
"We sat down with the GCP guidelines, and the monitoring plan follows in lock step the different sections in GCP, so we were sure not to miss any of the elements," Dykhuis says. "We also looked at the FDA documents that are available to the public."
The monitoring plan also details the extent of data monitoring. For instance, it says that monitors will review clinical data that affect study end points as defined in the protocol.
While the initial study consent process and initial study eligibility are reviewed for 100 percent of enrolled subjects, the extent of further monitoring could be revised, according to the monitoring plan, based on these considerations:
- History of protocol deviations or non-compliance with GCP guidelines
- Magnitude of data corrections required
- Complexity of the trial
- IRB request.
• Market monitoring service to investigators.
"We sent out a letter first and then invited people to come and have a conversation with the monitors," Dykhuis says. "Half the people came in and listened to a presentation and asked some questions about it."
Afterward, RSO staff called all of the investigators who had open IND protocols to find out whether they were going to choose to work with the clinical trial monitoring service, Dykhuis says.
"We tell investigators they have three options," Arbit says. "We say, 'You can use our service, and if you use it, you'll know it's done right; or you can monitor it yourself, and if you do that then we'll provide you with a monitoring plan that you need to follow and we'll be around periodically to make sure you are following the plan, or the third option is to hire a CRO or somebody else to monitor the study for you.'"
Since the program started, all of the investigators starting IND studies have chosen to use the monitoring service, Arbit says.
For the INDs that existed before the service was begun, marketing the monitoring service was more difficult, Arbit notes.
"Those are the individuals who would say, 'Gee, I never had to do it before, and this study is going on for six years now,'" Arbit says. "We'd say, 'I'm sorry, but this is what's supposed to be done, and here it shows in the regulations where this needs to be done.'"
Most of the time the investigators were grateful for the information and the chance to use a free monitoring service, Arbit adds.
For those who said they'd continue to monitor their own studies, Arbit would check in on them periodically and point out what they were doing wrong.
"Finally they'd come around," Arbit says. "People really see the value in these services."
• Expand monitoring services.
The monitors typically visit sites every six to eight weeks if the trial is accruing regularly, Dykhuis says.
For sites that have slow or no accrual, the monitors will use the time to look at drug accountability and to take a closer look at regulatory documents, she adds.
"We have a standard of [monitoring] 100 percent of inclusion/exclusion criteria and 100 percent of the consent process forms, so the initial consents are reviewed 100 percent of the time," Dykhuis says. "What we do after that is set a baseline of doing 10 percent of completed studies, and based on the error rates and risk level of the study, it might be increased."
Since the monitoring service has caught on, there has been an additional service offered of having a monitor help investigators with submitting their IND for approval, Dykhuis says.
"That allows us to provide assistance up front, before subjects even enroll in the study," she explains. "We can make sure the investigator has prepared the documentation in a way to make the study a success, and we provide a supportive role, like what pharmaceutical companies do when they go out and set-up sites."