Table 2.

Challenges of CCOP Participation

Appreciation for the Value of a CCOP “We’ve had some hard-liners within the hospital’s high-level administration that don’t understand what a CCOP is and why we’re here or what we do.” “I did have a meeting with the Vice-Chair of Medical Affairs two days ago and he understands cancer is a growth area. So I think that that is a good thing, but he doesn’t understand how much clinical research we are doing and how important clinical research is to the future of cancer care.” Understanding CCOP Operations “…there have been occasions when people have said that, ‘why do they have so many staff up there? How do they justify that?’ They don’t realize that we’re the operations office for all those other hospitals.” “But that [CCOP operations] also takes a lot of time to set up the right infrastructure and to organize the things that we had in control. For example, we had sites that we brought on into the department that those coordinators are still doing all their own regulatory. So then we centralized that about a year and a half ago.” Affording CCOP Participation “We get no funding from [hospital] and we got no funding from [hospital] either for [our research nurse]. And we get no funding for that second nurse… We just absorbed it as part of our operational expenses.” “I can tell you that [health system] wanted to cut our budget by $258,000, which in my mind means 4–6 of our 31 employees. I think we’ve always been faced with that [budget cuts] ever since I’ve been here. Nobody’s ever been let go, but we’re always faced with that.” And you know, they do receive funding in indirect dollars for all of that, but some of those dollars are still utilized to help support it and make up the difference the NCI cannot provide for us in direct dollars. So if we go over in supply costs for the year the hospital often times--it’s just seen as an expense where we went over and they just provide it for us.” Dealing with CCOP Requirements “CCOPs have their own level of responsibilities, requirements, very grant-specific things that don’t always mesh with what the strategic plan is for the hospitals. And sometimes that’s difficult to work together.” “We have had some of the other hospitals that are in our CCOP have had some trouble following the rules and we have had to sort of be the policeman related to that. That’s not easy for our staff and it takes time and effort. You’ve got to go out and be the policeman. And unless you are a lawman, you don’t really like that work.” “…some of the grant nurses say, ‘I would rather have someone looking my stuff over every 2 weeks because I hate the fact that I would be making a mistake for a year and then somebody finds that I did it on 5 patients.’ You know, it kind of depends on your perspectives. Some of our grant nurses have said that, ‘I’d rather have someone to sit with me and explain to me how they want these forms filled out and that versus waiting and in the audit and finding out I interpreted the schedule incorrectly.’” “There are deviations that are going to happen! Do you think that you can treat somebody for three years--there are going to be days where they are supposed to come in February the 2nd and they came in February 3rd. So what’s the big deal? The deviation is irrelevant. They call everything now a violation. How is everything a violation? And guess what? If it’s Monday, and the blood test was done on Thursday before, that’s four days. It’s a violation because of it’s not within three days. It’s not even relevant to the practice. So those are the kind of things which are driving us crazy.” Changing Workflow to Accommodate the CCOP “So we have transitioned. Originally we had just a lab liaison who was a lab employee that we just continually tried to work with her. … So we took over that position and now I supervise the person who is the lab liaison and so she’s a research coordinator. But she walks in and out of the lab; like she works in the lab and basically directs all the research-related activities, problem solves them. So the lab people still do the processing, but she oversees making sure that the lab reqs we give them are very specific about where to send things, what to do with them. So we’ve found that that’s worked well too.” “At the beginning we just had a pharmacy employee that was considered like the liaison to research and … we just kept trying to work with him on how to, you know, make things go better. Things would get lost in the pharmacy and no one would know where they put such and such and that kind of thing. … So over the years we have been able to get additional support so now we have a 0.7 [FTE], so close to full-time employee. But she is the research pharmacist for the CCOP and now she’s working with the components to come up with competencies for each of the component pharmacists and things like that. …. And I think that all these things just come in time as your program gets bigger.” Managing Patient Recruitment and Physician Involvement “You know I think what we’re finding is that we have good intentions. We open up the trial and then it doesn’t accrue and then you end up closing the trial. You know, like we have a couple breast studies that are outdated in terms of-and you know there’s some breast patients that you would not treat them this way now. So there’s some studies that are still open that you would say, why would you even open this up in the first place?” “[Physician commitment] is sporadic. You’ve got some really dedicated physicians who want to be involved in clinical trials and are very good at conducting clinical trials and accruals [i.e., recruiting patients to participate], and then you’ve got a lot who aren’t. You have to be that kind of physician who sees the bigger picture and the benefit of participating. Yeah, it takes time to participate in clinical trials and talk up patients and work through the IRB submission and some of the grants. And that’s often not rewarded so they have to go beyond.” Sustaining Administrative Support “There is still resistance from the hospital for, you know, making sure that the CCOP pays for itself. It seems to me like the hospital wants to make money off it, rather than saying all these are just good things… I think it just values profit-making research.” It’s always a giant struggle to hire new people even though we have the money for them coming in on the grant or coming in on the research.” “And this administration is much more focused on bottom line issues; whereas in the past, it hasn’t meant as much. I mean looking at departments specifically, and determining department by department, how much is it costing.”