CR Update: NIH research initiative NIH's Roadmap/Common Fund has been working to improve CT research

CTSAs generate new tools, strategies

When the National Institutes of Health (NIH) of Bethesda, MD, rolled out its Roadmap for Medical Research about eight years ago, the chief goals were to speed up the lab-to-bedside research process, strengthen areas in clinical research, and develop regional translational resource centers. The NIH would provide grant funding, and research institutions would create new strategies and best practices.

"The Roadmap was a series of programs designed to overcome particular research barriers, and it began through co-funding from all NIH institutes and centers," says Elizabeth Wilder, PhD, deputy director of the NIH office of strategic coordination.

"With the 2006 Reform Act, Congress gave this series of programs its own budget and called it the Common Fund," Wilder adds. "So we have begun to refer to the programs as the Common Fund programs."

Originally, the Roadmap was envisioned to be a five to 10 year program, but its success will translate into ongoing programs and work.

"They're accomplishing their goals and moving to other sources of support," Wilder says.

One of the successful programs resulting indirectly from this effort is the Clinical Translational and Science Awards (CTSA) programs, which have brought research leaders at major academic research institutions together to solve clinical research (CR) problems facing the industry, says Anthony Hayward, MD, PhD, director of the division for clinical research resources at the NIH National Center for Research Resources.

"Resources that already existed at NCRR were merged with Roadmap money in 2006 to create the CTSA," he adds. "We expect to reach a target of having 60 CTSA sites by July, 2011."

These 60 academic health centers will be committed to working together to share best practices and implement them, Hayward says.

CTSA sites have raised the overall standard of education across programs and have developed new shared informatics tools and data sharing agreements, he notes.

"If you Google REDCap you'll find new tools that enable investigators to use a template for a database that can be adapted to their research needs," Hayward says. "Or Google ResearchMatch and you'll find new tools available that allow people to indicate they would like to be part of a clinical trial."

ResearchMatch is a new and rapidly growing resource for investigators to use when recruiting clinical trial subjects. And CTSA funds have led to the creation of REDCap electronic data collection instruments, which have interoperability with electronic medical systems.

"One of the things clinical researchers need is access to patients and community outreach," Hayward says. "So we have urged, encouraged, and then made it compulsory to have a community engagement activity at all CTSAs."

Also, CTSAs are encouraged to share and collaborate, and some have done this in community outreach, he notes.

For instance, three Chicago CTSA sites collaborated in a capacity-building project to increase clinical trial enrollment, says Donna Jo McCloskey, PhD, program officer at NIH's division for clinical research resources at the National Center for Research Resources.

"All three sites have two different focuses, including their engagement with a practice-based research network and engaging their lay community in clinical research," she says. "Their goal is to make the community aware of research efforts at each of their sites and to expand this."

The original 12 CTSA centers agreed to work together and make these collaborations work for their individual institutions. This hasn't always been easy.

For instance, the CTSAs at Yale University in New Haven, CT, and the Mayo Clinic in Rochester, MN, decided that a sharing agreement reviewed and approved by their respective legal departments would allow for the maximum flexibility in sharing.

It also would define how CR tools created in the collaboration or by the individual institutions would be shared and used, says Cheryl Nelson, associate director of administration for Center for Translational Science Activities at the Mayo Clinic.

"We tried to keep the agreement very simple so that the document could also be offered as an example that other sites and principal investigators could use when dealing with similar sharing programs," Nelson adds.

"We thought we'd send it around to our legal departments [for review and expected it to take about] two weeks," notes Stacey Scirocco, executive director for administration and operations at the Yale Center for Clinical Investigation.

Instead, the legal review took about a year to complete.

While the end result is that the institutions now have a legal document that could serve as a model for other institutions involved in collaborations that might create best practice tools, it proved to be more difficult to achieve than anticipated, Scirocco adds.

When the NIH Roadmap was launched with the theme of re-engineering the clinical research enterprise, it had established implementation groups to focus on these areas:

  • Harmonization of clinical research regulatory requirements.
  • Integration of clinical research networks.
  • Enhance clinical research workforce training.
  • Clinical research informatics: National Electronic Clinical Trials and Research Network.
  • Translational research core services.
  • Regional translational research centers.
  • Enabling technologies for improved assessment of clinical outcomes.

As the CTSA stories show, research institutions are benefiting from the Common Fund's focus on collaboration and finding ways to spread best practices and research enterprise efficiencies.

For example, Yale and the Mayo Clinic have benefited from sharing successful tools and initiatives.

"We have a work group we call the IRB collaboration, and it's designed to identify IRB improvement initiatives that impact IRB processing times," Scirocco says. "Another aim is to facilitate scientists engaged in local clinics and other organizations to conduct human subjects research."

The CTSA project's main goal is to speed up initiation of clinical research and the overall timeline through a change of practices, she adds.

The Mayo Clinic has helped Yale with another goal of increasing minority inclusion in clinical trials, Scirocco says.

"Mayo has a great cultural advisor program that Yale is interested in modeling, and we want to learn more about their consent translations," she adds. "And we'd like to replicate it here and provide it as a resource for our investigators."

The Mayo Clinic has taken a look at Yale University's process for managing and working with affiliated IRBs, Nelson says.

"Yale has a very established process with specific operational, detailed procedures and templates that allow investigators to provide information to the Yale IRB and share information from the IRB to the affiliate," Nelson adds. "The Yale process allows Yale affiliates to utilize Yale IRB while Yale recognizes the local IRB review. It begins to address some of the aspects of a centralized IRB."

As part of the CTSA organizations' collaboration, they evaluate each other's tools, processes, and procedures and determine which items can be shared and used by each site and by other CTSA organizations.

The collaboration might result in the paired institutions coming up with a cost effective collaboration model that can be used by other institutions, Scirocco says.

"The idea is to look at what succeeds in both organizations and find a way to share the information," she adds. "The value of looking at each other's successes is that you can save a lot of time by documenting how that process works between the two institutions."

The NIH Common Fund has had some other notable successes, Wilder notes.

"Each of them has different goals and these are addressed in different ways," Wilder says. "One of the larger ones was the molecular library and establishment of small molecule screening centers around the country."

That program established a database that has been embraced by the chemical biological community, she adds.

The NIH Common Fund also has encouraged interdisciplinary research, helping to elevate this to a standard way of doing business in the research community within the past seven years, Wilder says.

"We were able to successfully put that in the forebrain of people's collective mentality," she says. "That program has been successful in testing new ways of doing interdisciplinary research."