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Institution starts monitoring service for in-house protocols
Investigators have gotten on board with service
For many institutions, the weakest compliance link is the investigator-initiated trial because there typically are no clinical research organization (CRO) monitoring visits to ensure documentation and other details are in order.
The University of Minnesota in Minneapolis, MN, found a solution to this issue by recently starting a clinical trial monitoring service that is offered to researchers who have developed their own protocols.
Sponsors, even when they are also the investigators, are required by the Food and Drug Administration (FDA) to provide trial monitoring, but the question is how detailed, objective, and useful is the monitoring plan?
For institutions that want to be certain any study's monitoring plan is top quality, the key is to offer a monitoring service to investigator staff, experts say.
"We try to communicate to people that this is a new service, but it meets an old requirement," says Debra Dykhuis, CCRC, CCRA, associate director of the Research Services Organization, Academic Health Center, University of Minnesota.
"In an academic center, what's really key when you start a program like this is to focus on the service element," Dykhuis says. "We've been successful because we really are partners with investigators, and we've focused very much on how this is a service function — not a compliance function."
The monitoring service has about 40 active protocols under IND and IDEs that are being handled, Dykhuis says.
Also, the institution's cancer center has started its own monitoring service for cancer trials, she notes.
Prior to forming the monitoring program, the university had started an IND/IDE assistance program.
Harvey M. Arbit, PharmD, MBA, RAC, is the IND/IDE assistance program director, and as part of his work in getting the program started, he identified the institution's sponsor investigators.
"I was not as concerned about the faculty who were investigating under a pharmaceutical company IND because big pharma and big device companies make sure their investigators comply with regulations," Arbit says.
"Once we had identified all of the faculty members who were sponsor investigators, I went out and met with them and looked at their regulatory binders," Arbit says.
He found variability in compliance, and many investigators were not familiar with their obligations as an IND sponsor, Arbit says.
"Most of them had been investigators under commercial INDs, and they knew what their obligations were as investigators," he adds.
But they often didn't understand all of the reporting that is required of sponsors, so Arbit decided to educate sponsor investigators about their obligations.
While educating investigators, Arbit asked them how they were monitoring their studies. Sometimes they responded with confusion, mistaking the data safety monitoring board's duties with clinical trial monitoring, he says.
"I'd say, 'That's not what I'm talking about — I'm talking about clinical trial monitoring where you look at the accuracy and validity of the data,'" Arbit says. "You want to be sure the study is being done according to the protocol and that you're obtaining informed consent and that the data you've transcribed from the case report form is transcribed appropriately and correctly."
Investigators reported that they were doing all of this, but they weren't documenting their monitoring activity, Arbit recalls.
"The FDA says that if it's not written down, it didn't happen," he says. "The FDA wants to see your monitoring reports."
Investigator sponsors can monitor their own studies, but if they choose to delegate the task, the person they assign to monitor must be qualified by education and experience, according to FDA regulations, Arbit says.
Without careful monitoring, the data could be incorrect, he notes.
"Things happen: you put the decimal point in the wrong place; you transpose numbers; you put the value on the wrong line," Arbit explains. "If you do not have someone there to check this and you go ahead and start doing your statistics, then you might come up with an incorrect result."
The solution was to start a monitoring service that would follow good clinical practice (GCP) guidelines.
"We decided when developing the monitoring program that GCP standards would be the minimum standard for conducting academic research," Dykhuis says.
Although it took time to educate investigators about the monitoring service and to show them its value to their work, this effort has paid off, Dykhuis and Arbit say.
"People have responded very enthusiastically and positively to this service, and it didn't start out that way, so it's been very gratifying," Dykhuis says.
"We had an investigator who wasn't wild about the idea of having a monitoring service, but she agreed to have us monitor her trial," Dykhuis says. "And what's happened is our monitors have worked with her and she actually requested whether it would be possible for her to buy a day of the monitor's time and write it in her research grant."