Improving site-sponsor-CRO relationship
Resolve issues by being proactive
Conflicts inevitably happen between clinical trial (CT) sites, sponsors, and clinical research organizations (CROs). But when they occur they can be handled efficiently and in a way that doesn't slow down the trial or reduce efficiency.
Also, some CT sites have developed proactive measures to reduce conflicts, improve communication, and foster trust in this three-pronged relationship.
Here are some of the issues that arise:
• Protocol design: "The big issues come up with protocol design," says June Cassano, RN, BSN, MBA, a research administrator for the Heart & Vascular Institute, as well as one of the managers at the Center for Clinical Research of the Cleveland Clinic in Cleveland, OH.
In a best case scenario, sponsors will ask clinical trial sites and investigators to review study protocols and provide feedback, Cassano notes.
Many problems involving protocols could be resolved in advance if sponsors were to solicit input from CT researchers, but this probably doesn't happen as often as it could, she adds.
• Assess enrollment potential: CT sites could prevent much of the recruitment and enrollment problems that plague the CT industry if they'd conduct thorough feasibility assessments.
"I'm not sure if every site has taken a critical look at protocols coming their way," Cassano says.
Perhaps the most effective way to assess a study's feasibility is by conducting a mock protocol assessment with a retrospective two-week screening for patients who meet a study's inclusion/exclusion criteria, she suggests.
"When we do feasibility assessments, and depending on the type of trial, we would like to see that at least 50% of patients qualify for the trial, and the higher the number the better," Cassano says.
The easiest trials to enroll are those that have more general criteria for a specific disease process. But others require CT sites to use specific parameters, and these need to be thoroughly assessed, she adds.
At the Cleveland Clinic, a study coordinator will perform the retrospective assessment, and the manager will help analyze the findings, Cassano says.
"Some of the information will be available electronically, and some will require a manual process where we have to dig a little deeper," she adds.
For example, a CT coordinator might look at the inclusion/exclusion criteria for a study that would involve patients in the interventional cardiovascular medicine section of the Cleveland Clinic's Heart and Vascular Institute, Cassano says.
"We assess patients who came out of the cath lab over the past two weeks to see if they fit the criteria, and maybe we have a total of 600 patients," she explains. "So what percentage of those patients makes the inclusion/exclusion criteria, and what percentage of those who meet the criteria might enroll in the study?"
If only 30% meet the criteria, then the site's leadership will have to consider whether it's worthwhile to continue with the study, she adds.
"You might want to move forward with some types of trials that involve the latest and greatest and hottest technology because they're state-of-the-art," Cassano says.
• Assess sponsor and CRO experience: Another part of assessing study feasibility is to assess the particular sponsor and CRO.
"Has your previous experience with the sponsor or CRO been satisfactory?" Cassano says. "If you haven't had any experience with them then have you checked with colleagues to see if they have a good reputation?"
Site managers should ask these questions as part of sponsor/CRO assessment:
- Are the study's enrollment goals realistic?
- Is the enrollment period realistic?
- Will there be competition with other studies using this population?
- If there is competition, how will you handle it?
- Do you expect a significant number of adverse events?
- Will there be frequent subject follow-up?
- Is there a big commitment on the patient's part with regard to travel, and could that impact enrollment and retention?
"These are all part of feasibility assessment," Cassano says.
The potential for adverse events is particularly important to assess, she notes.
"At the Cleveland Clinic, we had one study with a drug where one FTE (full-time equivalent) had to be devoted to report all of the adverse events from that particular drug," Cassano recalls.
The sponsor hadn't included funding to support that position in the study budget, so the clinic negotiated a slight increase that helped the site recoup some of the lost revenue, she adds.
• Handling delays: Sometimes CRO monitors get behind on site visits, and this will delay payment to the site, Cassano says.
"Sometimes there's a backlog of patients, and then the monitor needs to come in for a few days to go over this, and that can tie up the coordinator, who has other duties and other trials," she explains.
"When this happens, we'll speak directly with the sponsor or CRO about the problem," Cassano says. "We have complained about this in the past to a CRO, and the CRO listened to us and tried to come in on a more regular basis."
• Resolving complaints: CRO monitors sometimes will note communications or documentation problems with study coordinators in monitoring reports even though these could have been handled directly through communication with the site, Cassano says.
"We have found that some items they've listed as a concern were not problems," she adds. "So we've had to go back to the sponsor and have them update the report based on that communication."
The key to preventing these types of issues is for the study coordinator to develop a good relationship with monitors, Cassano says.
"On the day the monitor is coming in to visit, the coordinator has to have this on the schedule and tend to the needs of the monitor," she adds. "That helps."
Also, before a monitor leaves, the coordinator should sit down with the monitor and work out any issues or questions, Cassano says.
Conflicts inevitably happen between clinical trial (CT) sites, sponsors, and clinical research organizations (CROs). But when they occur they can be handled efficiently and in a way that doesn't slow down the trial or reduce efficiency.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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