Children's hospital saves time, money through centralized services
Children's hospital saves time, money through centralized services
Investigators, sponsors, patients all benefit
Medical and research institutions that centralize clinical research services can help physician investigators improve study quality and efficiency and save money through better budgeting, an expert says.
Connecticut Children's Medical Center in Hartford, CT, made a decision to centralize clinical research services several years ago, and the result has been well worth the expense and effort, says Lisa Benson, CCRP, manager of research administration and finance.
The centralization of services has resulted in research budgets that typically are right on target, and it has helped physicians without research experience get involved in studies they might otherwise not have attempted, Benson says.
Also, since one coordinator handles most of the IRB submissions, there's efficiency in that process, Benson notes.
"The coordinator knows the format the IRB likes and the language they want, and it helps prevent study delays," Benson says.
The IRB approval process typically takes about six to seven weeks but, even when contingencies are required, these are sent back to the IRB promptly and are quickly approved, she adds.
The medical center, which is almost 11 years old, has about 50 on-going studies that are handled — at least in part — by the centralized clinical research team of nine, Benson says.
"We have centralized services where one division does the regulatory documents, preparation for all 1572 financial disclosures, licenses, and all of that," Benson says. Other members of the centralized research services staff include these disciplines:
- a clinical laboratory technician who reviews laboratory manuals for various studies and knows how to work with research studies;
- an administrative assistant dedicated to clinical research trials;
- five clinical research coordinators — three who are full-time and two part-time; they are trained and experienced in conducting trials and IRB submission;
- a manager who reviews study budgets and can assist with contract negotiation, which is Benson's role;
- a clinical manager who provides compliance oversight, with regard to participant registration and billing procedures.
The medical center supports the managers on the team, but the study coordinators' salaries have to be covered by research projects, Benson notes.
"When we started, we had a staff of three," Benson says."So we've grown in the past four years."
Benson offers this example of how centralized services can improve the budgeting and contract negotiation process:"We had a physician new to research who negotiated a study budget on his own, and a check was sent to this office," she says.
"I didn't know anything about this study, so I contacted the investigator and said 'I'd like to review the budget and contract,'" Benson says."I found that his budget was $50,000, but when I calculated the budget I came up with $135,000."
So Benson called the sponsor and told them the physician had come up with the budget on his own without looking at all of the hidden costs.
"The physician had planned to use his clinic nurse, who sees all of the patients, and she didn't have time to do this study, too," Benson says."There was no way she'd be able to carry out her regular duties and complete this study."
Under Benson's budget, the study would require a research coordinator, and there was a fee budgeted for IRB services, both of which were missing from the doctor's budget.
Once the sponsor reviewed Benson's proposal and saw the revised study budget, the sponsor agreed that the higher amount would be necessary to do the study and they paid it, Benson adds.
If the doctor had proceeded on his own, as would have occurred without the centralized services, he wouldn't have been able to complete the study as budgeted, Benson says.
"When I did a review, I sent it over to a statistician," Benson says."His sample size was off, and he never would have gotten the answer to his question."
The investigator doctor was grateful for the help, and the institution and sponsor were both better off with the revised budget.
Benson offers this advice on how to centralize clinical research services:
1. Obtain buy-in from the top.
At Connecticut Children's Medical Center, the director of research operations realized there was a need to have research projects handled through a specific area for better compliance and other reasons, Benson says.
"Institutions are under such a microscope now for compliance and making sure they follow the good clinical practice," Benson notes."When dealing with pharmaceutical companies, it makes sense to give contracts to experienced people to review."
Plus, physicians have such high demands on their time in the clinic that there's little time left for research, she adds.
"So we felt that if we could give them the help and tools they need then it would help them carry out research," Benson says.
One reason it was not a hard sell to the medical center's leadership was because the centralized services area started small with only three institution-supported salaries, Benson says.
2. Introduce concept to physicians.
Benson and the clinical manager visited the various hospital departments to introduce the centralized services to physicians and others.
"This gave us an opportunity to find out what was going on out in the institution," Benson says.
During meetings with physicians, Benson and the clinical manager would ask them what research they were doing, if any.
Then they'd tell them,"If you'd like to be involved in research, this is what we could do to support your research so you're not doing it on your own," Benson says.
They'd say,"There's no reason for you to do IRB submission and contracts with sponsors because we can do that for you," Benson says."Many investigators didn't know that institutional officials could sign contracts, and once they learned we were here to support them, we began receiving more and more research protocols that investigators wanted to do."
So physicians would call the centralized research office when they were contacted by pharmaceutical companies and ask for assistance with research contract negotiations and budgeting.
"Soon, more and more people started to use us, although we still had one or two investigators who were a little fearful about losing control," Benson recalls.
If an investigator wants to do a study but doesn't have the necessary resources in his or her clinic, then the centralized office will provide the staff and assistance needed.
"I believe there is overall efficiency in study management now, whether it's for doing case report forms or administrative support," Benson says.
Even the physicians who thought that using the office would result in a loss of control or a monetary loss have been won over to the concept of centralized research services and are using the office for studies, she notes.
"They find their studies are budgeted much more appropriately, and they're getting the dollars they need to cover all study costs," Benson says."And the contract negotiations take into consideration all of their interests, including publication rights."
There still are some departments that have their own dedicated research coordinator, and these typically are areas where the research is highly specialized, such as pulmonary, gastrointestinal, and hematology/oncology, Benson says.
"So those research coordinators are not housed with us and they're not paid by us," she adds.
But even in these cases, investigators often use the centralized office for other services, including budgeting, contracts, etc.
3. Train research staff.
The institution has staff take the Collaborative IRB Training Initiative (CITI), which can be found online at www.citiprogram.org. CITI provides education in human subject protection for biomedical and social/behavioral research.
Everyone involved in research is required to take CITI training, Benson says.
"And we urge our coordinators, within two years after they're hired, to obtain certification, usually from SoCRA," Benson says.
Investigators also have to take CITI courses, which the institution pays for, Benson says.
The education is required, and if they haven't completed the courses, then their research proposal will not be processed by the IRB, she says.
4. Provide ongoing outreach.
"When new clinicians are hired, we get contacted, and we put it on our calendar and schedule appointments with them and bring them materials about the clinical trial unit and centralized research," Benson says.
"We'll ask the new clinicians whether they've done any research in the past and which areas they're interested in researching," Benson explains."We ask if they would like us to contact them about trials in their areas of expertise."
The centralized office has assisted in encouraging six new investigators to begin research in the past two years, she adds.
"I think if institutions can set up a centralized research office, then it helps the institution stay in compliance, and it provides support to investigators who would like to do research but don't have the time and resources to do it," Benson says."From the sponsor's perspective, it minimizes their time on the site, and we keep hearing from the sponsor that the centralized office is 'great.'"
The centralized office has helped to strengthen sponsor-trial site relationships, and it's helped patients and their families by enabling the institution to offer more research using cutting-edge technology and state of the art medicine, Benson says.
Medical and research institutions that centralize clinical research services can help physician investigators improve study quality and efficiency and save money through better budgeting, an expert says.Subscribe Now for Access
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