Clinical trials units strengthen infrastructure
Investigators and coordinators make it work
Universities, research organizations, hospitals, and other entities increasingly are finding that there are benefits to forming clinical trial units within specific clinical practices and departments. Clinical trial units assist physician investigators and others in conducting research, laying the groundwork for better success in research contracts and subject enrollment, provided the unit follows best practice guidelines, an expert says.
"It makes sense to have certain things in place to make research work, specifically in a research setting," says Jennifer Williams, CCRP, RN, manager and head research nurse coordinator of the clinical studies unit of the department of dermatology at the University of Pennsylvania in Philadelphia.
The No. 1 main reason to form a clinical studies unit is to make the research foundation structurally sound, Williams says. "When you do research loosely you don't necessarily do it right," Williams says. "When you have guidelines in place and have the infrastructure established you can streamline the way you do research and become more efficient, so across the board, everything improves."
Williams offers these guidelines for ensuring a clinical trials unit is run efficiently and successfully:
• Focus on improving communication: Often there’s a breakdown in communication in the research setting, Williams says. "The typical feeling among clinical research coordinators is that they’re isolated from everyone else and no one knows what they're doing," Williams notes.
"E-mail communication is not sufficient," Williams says. "Although people think if they e-mail they’re communicating, that's not the case." For instance, co-workers and colleagues often become angry with each other over an e-mail, which may be difficult to understand without the context of what face-to-face communication brings to an interaction, Williams explains.
To facilitate more face-to-face communication, a clinical trial unit could form an advisory committee that includes all investigators and nurse managers who are involved in an active clinical trial in that fiscal year, Williams suggests. "We have quarterly meetings with the advisory committee," Williams says.
Also, a clinical trials unit could establish policies that require study coordinators to meet with investigators at least every two weeks, she says.
• Decide how best to staff the clinical studies unit: "We have a medical director who, in our case, is a junior physician," Williams says. "He has a lot of grants and is research-oriented." The medical director was the person Williams met with initially when plans for the clinical studies unit were begun.
"We work with the business administrator with the department, and we have input into our budgets and how the money flows," Williams says.
When studies are initiated, Williams, the medical director, and the business administrator work with the investigator to determine the study’s feasibility, she says.
"We work together under the department chair, and the work itself goes to the clinical research coordinators and assistants, who deal with the paperwork part of the study," Williams says.
• Consider financial feasibility: "We have various mechanisms in place to very quickly prove the financial feasibility of a study and to determine what the budgetary requirements are for conducting a study," Williams says. The process could take anywhere from a day to a couple of weeks, Williams says.
Prior to having the clinical studies unit, studies often would be initiated and staffed only to be stopped after significant money had been spent, Williams notes. "Now, we’re the stopping point before the study gets a coordinator," she says.
Also, the unit focuses on phase III industry-sponsored studies that are economically advantageous for new clinical trials units because they pay well, Williams says.
Alternately, the unit frequently is approached to do phase I or II studies that present more of a challenge financially because they have a huge regulatory burden and a small number of patients, she says.
"You may negotiate a high payment per patient, but you’re not going to get 50 patients —you’ll look for five," Williams says. "Everything having to do with safety is an astronomical amount of work."
While the unit will do any kind of clinical research from phase I to phase IV to observational studies, the unit’s policy is to only do studies that have a financial sponsor, Williams says. "What happens is they tell me what kind of funding they think they can get and then ask me to tell them how much I think the study will cost to do," Williams says. "If a study does not have the funding that they need then they can either pursue another source of funding or speak with the department chair and discuss their shortcomings in pay for the study, and the department chair will decide whether or not the department will partially fund it."
The clinical trials unit does not fund studies, so if the money is not there, the study cannot be done, Williams adds. The unit’s goal is to be cost neutral with no profits earned, but all costs have to be covered, Williams notes.
These estimates are negotiable, but with budgeting it’s always a good idea to begin with a conservative figure. For example, if a trial budgets 10 minutes for a research coordinator to check someone’s heart beat and blood pressure, this may be unrealistic. In the real world, the coordinator might need 20 minutes because there is no easy access to the blood pressure machine, Williams says.
• Assist with regulatory submissions: Often studies need to be submitted to several committees for review, including the IRB. At the University of Pennsylvania, there’s a general clinical research center (GCRC) that is funded partly by NIH to perform clinical trials. Any study in which an overnight visit or otherwise extensive visit is planned, then the study will need to be reviewed by the GCRC committee, Williams says.
"Their committee only meets at certain times, so you have to coordinate how you submit it," she says. "You could lose a month or two."
Also, the GCRC won’t consider cancer protocols until they’ve received full approval from the cancer study, Williams notes.
"It can take six to eight months of regulatory work before it gets full approval because there may be four or five committees where you need to get approval," Williams says. "It may go through the cancer center, MRI, radiation and environmental health, the GCRC, and the IRB."
The clinical studies unit assists investigators in the entire submission package, including protocol summaries, informed consent, etc., Williams says.
"We educate the physicians along the way," she says. "We have regulatory knowledge, and the physicians have working knowledge of the regulations, but they have no knowledge of the logistics of getting from point A to point B to point C."
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