Clinical trial offices have diverse roles & goals, new survey shows
Consolidation might improve efficiency
Academic health centers have increasingly added clinical trial (CT) and research offices to assist investigators and others involved in the research enterprise. But so far no one model has taken hold in the industry, a new survey reports.
The study's findings suggest there is room for best practices and greater uniformity in establishing CT offices.1
"Each institution is very different," says Elaine Rubin, PhD, vice president for policy and programs at the Association of Academic Health Centers (AAHC) in Washington, DC.
"Whether they're private or public or large or small, they have different structures and cultures and ways of managing the offices," she says. "While everyone is trying to get to the same goal, we saw different ways of getting there."
These findings surprised Rubin, who began working on the project in late 2008.
"I thought they'd all be doing pretty much the same thing," Rubin says. "But what we found is there are at least 14 activities that can range from contract negotiation to recruitment to protocol development."
Even within the context of education and training of researchers and research staff there was variety, she adds.
"We thought we'd find a little bit more uniformity in the structure, and we did not," Rubin says.
One reason for this trend is that the clinical trial enterprise of academic health centers is relatively small when compared with the organizations' historic research activities, says Steven Wartman, MD, PhD, president and chief executive officer of AAHC.
Through funding by the National Institutes of Health (NIH), these organizations have built up tremendous research capabilities and have become world leaders in research, Wartman says.
"We haven't paid similar attention to clinical trials," he explains. "They've been relatively small, but are a vital portion of the research enterprise."
The modest investment in CTs has led to CT offices' variety in roles and functions, he adds.
"It was only in the last decade that it's caught our attention," Wartman says.
The research industry has begun to see that more emphasis and attention must be paid to clinical research and to the translation of basic science findings into clinical practice, Wartman says.
"The translation of basic science findings into clinical practice is becoming more important as people realize there's a tremendous need to develop that area," he adds.
AAHC's survey documents CT office variety, he notes.
"We thought maybe there is a need for an organization like ours to recommend some methodologies that would describe economies of scale and best practices for clinical trials management," Wartman says. "This goes well beyond academic health centers and the agencies that regulate them."
The next step might be for a professional organization, such as AAHC to publish CT office models that consolidate the various functions.
The AAHC report suggests that clinical trial sites benefit from consolidation or centralization, but this is far from being accomplished.
Consider consolidation
For institutions that have a myriad of CT offices and functions, many within individual departments, they might consider consolidating these offices to reduce overlap and increase efficiency.
Institutions that move to a one-stop-shop model appear to have made it easier for researchers to find the information and assistance they need, Rubin notes.
The lack of a clearly defined organizational structure for clinical trial administration creates stress and challenges for research institutions.
Problems include the lack of mandates for using CT offices, the overlap of general CT offices with departmental services that provide CT assistance, and the lack of skilled technical labor.
CT offices in academic health centers often have parallel structures, Rubin says.
"They're getting the job done, but researchers might be getting help in their department," she explains.
So when an organization establishes a general clinical trials office that can be used by everyone at the institution, there might be a problem with attracting researchers to using it. This is where a mandate requiring its use might be effective.
"What we're finding is there is increasing use of these offices by researchers because they find it helps them and are effective," Rubin says. "But its use is by word-of-mouth, and not by policy."
This means institutions often are not using their CT office resources as effectively as they could be using them, she adds.
It's also ineffective to have an overlap of CT functions within departments.
AAHC is working with the Centers for Medicare & Medicaid Services (CMS) to make clinical trial rules less ambiguous and to advocate for more CT funding, Wartman says.
"We'll assist our members in developing methodologies to make sure their management of clinical trials is efficient," he says. "We also have a clinical trial toolkit which was a tremendous endeavor."
The toolkit, which can be purchased through the AAHC Web site, provides assistance with conducting self-assessments and other activities that will help an institution develop more efficient clinical trial management and style, Wartman adds.
AAHC's clinical trial office report features profiles of institutions' clinical trial operations. Each profile is based on one institution and are not necessarily models to follow, Rubin explains.
"We don't have model A, B, or C available yet," Rubin says. "These examples all are working and address the needs of a particular institution."
Some institutions added their CT office to existing infrastructure, and so its functions and purpose are tailored to fit in with what the institution already has, she notes.
"Just like the universities out there, they have different histories, different resources, different research priorities," Rubin says.
But the clinical research enterprise is evolving, and research institutions need to change with the times.
"Academic health centers are deciding they want to put more emphasis on the clinical research arena, so they have to evolve," Rubin says. "We want to stay a little ahead of the curve and provide a model, but we're not there yet."
Key features
As research institutions develop new or modify existing CT offices, they might include these features, Rubin suggests:
• Budget development: "They definitely have to deal with budget development and approval," she says.
Also, it's important to conduct cost analyses, Rubin adds.
• Protocol development: "They should be helping with protocol development, and this should be linked or at least be in contact with what's happening in the IRB office," Rubin says.
• Contract negotiations: Clinical trial offices would be helpful in contract negotiations, she says.
• Education, training, compliance: There should be some element of education and training and compliance in the CT office. Or at least the CT office should be linked with the education and training and/or compliance offices of an institution to ensure all regulatory issues are addressed, Rubin says.
"Research coordinators need to have the experience and training to know the research environment, regulations, billing, and recruiting patients," Rubin explains. "These are high-stress jobs, and we see a lot of turnover."
The coordinators who are skilled quickly move up to other jobs, and there often are too few new people moving into these roles, she adds.
Reference
- Rubin E, Lazar D. Clinical trials offices: what's new in research administration? Published by the Association of Academic Health Centers. September, 2009: Available online at http://www.aahcdc.org.
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