Translational science consortium sets out to improve process
Task force sets sights on multicenter studies
A new consortium of research institutions is seeking to transform the process of translational research, in hopes of progressing more efficiently from scientific breakthrough to patient treatment.
Funded by the National Institutes of Health, the Clinical and Translational Science Awards (CTSA) have taken on a number of areas of concern, including training and mentoring for researchers and designing new clinical informatics tools.
James A. Moran, JD, CPA, is executive director of the Center for Clinical Studies at Washington University in St. Louis, MO, and chairman of the CTSA's Regulatory and Ethics IRB Taskforce, which seeks to work with CTSA institutions — currently numbering 38, but set to increase to about 60 by 2012 — to come up with better ways to achieve multisite IRB review.
Because of the CTSA's goal of improving the "bench-to-bedside" process, Moran says it was an obvious choice to focus on issues surrounding IRB review of multicenter studies.
"We're anticipating an increase in the number of clinical trials we're going to do, and we anticipate they will be done largely through other CTSA recipients," Moran says. "If you have 10 or 20 different sites, all academic, the IRB approval process is a major area of interest, in terms of how long it will take to enroll your first subject."
Faster and better
He says the task force's goal is to find ways to break through institutional bureaucracies to better handle investigator-initiated multicenter clinical studies.
"Not only faster, but better," he says. "That includes the quality of the research itself and also the protections given to our research participants."
Individual institutions have received CTSA grants to work on their own ideas for improving translational research. Moran says his task force hopes to take the best of those ideas and promote them across the CTSA network.
But he says the members of the task force have expressed a desire to go further.
"We've been talking about doing some research on the research process itself," Moran says. "It would mean looking at practices at some of the institutions that are part of this task force and seeing what are the value-added steps, what are the high-quality things that we do, and what things maybe provide more burden than quality — burden to the investigator, burden to the institution."
Currently, he says, the committee doesn't have funding for such research, but Moran says the task force is looking at how they might carry it out.
Articles and regulatory advice
In addition to his new position with the IRB task force, Moran also serves on the consortium's Clinical Research Management Taskforce, which plans to establish a common set of measures across CTSA organizations. One of them would look at the length of the IRB approval process.
"Very soon after we start tracking in a common, consistent way how long it takes to get things done, the next question is how we can improve that," Moran says. "I think that's really the role of this IRB task force — to come up with some concrete things we can do based on the research and based on the available evidence."
Moran says the task force members hope to be able to publish a white paper or journal articles to help disseminate what they learn as they examine the IRB systems at the CTSA institutions.
The task force also could work through common IRB issues arising at its various member institutions.
"When we have common questions that all of the institutions are dealing with, rather than coming up with 24 different ways to do something, there could be a common approach that might be able to be replicated across institutions," Moran says.
Beyond that, armed with data from the CTSA institutions, Moran hopes the task force could provide some suggestions to regulatory agencies to help form future guidance for other IRBs.
The IRB task force only began meeting in March and Moran concedes that it could be a while before they can achieve all of their goals.
"There are certain things that we can do fairly quickly," he says. "If we were looking at something that an institution did particularly well as a model practice, we can get those model practices out there fairly quickly in the next six to 12 months.
"But these bigger picture things — doing the research, coming back with data, and talking to the regulatory authorities — that's going to be a much longer time frame."
Despite the task force's interest in regulatory issues, Moran says, the goal of this process isn't more requirements.
"The outcome here, we hope, is to come up with a more logical framework across institutions," he says.
Although this is hardly the first effort to address issues raised by multisite review, Moran says he's optimistic that the unique nature of the CTSA consortium can lead to success.
"The collaboration between organizations is very high in the CTSA," he says. "I think that's really a unique approach. Rather than just working on a problem, we're also being tasked with getting the work done — that's what makes us different.
"The CTSA, in order to be successful overall, is going to have to do more clinical trials," Moran says. "We're working on an issue that we think could be an impediment to doing that. So I think these institutions are now motivated to work together to come up with a way that we can do this better."
For more information about the National Institutes of Health's Clinical and Translational Science Awards, visit the consortium's web site at: www.ctsaweb.org.
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