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Clinical trial staff benefit from one-stop shop
A model research center in Maryland has become a major research entity that provides start to finish assistance to investigators and clinical trial professionals.
The Center for Cardiac and Vascular Research at Washington Adventist Hospital in Tacoma Park, MD, has become one of the top 10 enrolling centers in the United States since it was formed in 2001.
Prior to 2001, the hospital's research was physician-oriented and mostly conducted in individual physician offices, says Dawn Shaddinger, MSN, RN, CCRN, administrative director for the Center for Cardiac and Vascular Research.
Now, the research center, which is a hospital department, provides physicians who are interested in cardiac or vascular research with a place to bring their protocols, she says.
"We can see if the protocols are feasible and if there is an adequate patient population for enrollment and recruitment," Shaddinger says. "We'll take the protocol and totally prepare it for IRB submission, make sure we have all of the equipment that's needed, and that we have all regulatory documentation."
The one-stop shop frees investigators to focus on the research part of the study, leaving the paperwork to experts.
Prior to the center's opening, there were a handful of physicians who were involved in research, Shaddinger notes.
Now there are 20 to 30 physicians who conduct research, and many of them might not be involved in studies if it weren't for the center's assistance, she says.
"This structure has allowed for doctors in solo practice or who are new in practice to be involved in research," she adds.
"The other advantage is that because we're not run out of a physician office, we're able to get physicians from various physician practices to be sub-investigators on the protocol," Shaddinger says. "So, we'll get a higher enrollment and have a trained coordinator who can be a lead coordinator on the study."
When the center first opened, Shaddinger and staff used a marketing brochure to explain its infrastructure and to show what services and skills the research center could offer physicians.
Marketing staff helped them with promoting the center's services, including putting information on the hospital's Web site, Shaddinger says.
Here are some of the services the research center provides:
• Assess the protocol for feasibility: Shaddinger, a regulatory expert, a research coordinator, and the principal investigator all will read the protocol, looking for answers to these questions:
- What are the requirements of the protocol?
- Does the institution have the necessary equipment to handle the protocol?
- If not, will the sponsor provide the equipment?
- Is there enough space for the equipment?
- How labor intensive is the study?
- Does the institution need to hire additional staff to handle the study?
For the next step, they look at the contract to assess whether the institution's and investigator's costs will be met, Shaddinger says.
The center's committee of four will evaluate the protocol subjectively and discuss their thoughts about its feasibility, she says.
Shaddinger has an Excel spreadsheet for the protocol's budget.
It includes a list of all charges, including overhead costs, she says.
Some sponsors present very reasonable budgets in the contract, and others are too low, she notes.
"So it's important to assess what your charges are, and for me it has been most beneficial to work with our finance people," Shaddinger says.
• Begin IRB submission and contract negotiation:
Most of the time they accept a protocol, and the center's staff will then begin to collect regulatory documents, Shaddinger says.
"I have a full-time regulatory coordinator who will prepare the documents for IRB submission and submission to the sponsor," she says. "At the same time, they go through all the elements the legal department requires."
These two activities can take four to six weeks to complete, and doing them simultaneously helps to ensure the process will be completed in a timely fashion, Shaddinger says.
"Our legal department has provided us with standard language they'd like to see in all contracts," Shaddinger says. "So when the sponsor sends the proposed contract, we red-line it with our specified language and then send it to our legal department for an initial review."
Once the legal department gives it a green light, it's submitted to the sponsor for approval and signatures.
• Provide enrollment, study visit, and other assistance:
"Research nurses will evaluate patients that are referred to us by the physician for inclusion and exclusion," Shaddinger says. "They look at lab values, medical records, and spend considerable time speaking with the patient and going over the protocol, making sure all questions are answered."
The staff nurses also will make certain each patient understands what the study is about and has a copy of the informed consent form, she says.
"We have them give us feedback, and we make sure they know how to get in touch with us if they have any questions," Shaddinger says. "We ask the patient, 'What are you agreeing to do?' and see if they can explain what a randomized study is."
If the patient's answers indicate he or she doesn't understand how the study will work, then the nurse will spend more time going through the informed consent and clarifying issues, answering all questions, Shaddinger adds.
The research center also assists with patient follow-up, setting up appointments in physician offices, if appropriate, she says.
"We make sure we get answers to questions as needed to the patient report form," Shaddinger says. "And if there are serious adverse events, we make sure we're getting records about it and all source documents that are needed, including medical records from outside hospitals, physician offices, and maybe even a copy of the death certificate if a patient dies."
Once the research center has collected all of the adverse event documentation, the investigator needs only to review the information and sign it, she adds.
"If it's a serious adverse event, then we submit documentation to the IRB and sponsor," Shaddinger says.
The research center handles all regulatory visits, as well, Shaddinger says.
"If a physician is notified of a Food and Drug Administration visit, then I'm the next phone call," she says. "If the IRB requires additional information, we do it."