Wednesday, October 20, 2004

DCRI, Duke Researchers Win NIH Roadmap Grants
By Julie McKeel

Dr. Bob Harrington, Director, Cardiovascular Clinical Trials, and Dr. Carol Dukes Hamilton, Associate Professor of Medicine, Division of Infectious Diseases and International Health were each recently awarded grants as part of the "Re-Engineering the Clinical Research Enterprise" component of the National Institutes of Health (NIH) Roadmap for Accelerating Medical Discovery to Improve Health, described at http://nihroadmap.nih.gov/. These grant awards total nearly $3 million each over 3 years. Dr. Kevin Schulman, Director, Center for Clinical and Genetic Economics, was awarded a 5-year, $3.9 million grant as part of the same Roadmap initiative.

Bob Harrington, MD

According to Harrington, numerous public and private sources have expressed the need for a more efficient and effective approach to clinical research over the past several years. "One of the greatest inefficiencies of the current model of clinical research in our country is the lack of shared resources, common data standards, and effective use of information technology among researchers," says Harrington.

"The concept of a "network" is a step in the right direction toward advancing the nation's clinical research capacity," adds Harrington. "The operational efficiencies of a network of investigators, coupled with the scientific camaraderie that develops among researchers having similar goals and interests, should advance the field of clinical research."

Harrington proposes a customer management approach to interacting with network sites that will facilitate clinical research by enhancing site recruitment, training, performance, and accountability and by creating a sustained improvement in the efficiency and quality of the interaction between the clinical research subject and the investigator.

Harrington's approach has four components:

• Treat the clinical research site as a customer, creating a mechanism to define and share best practices designed to engage, support, and invest sites in research.
• Use cardiovascular disease as a model for developing common data elements and standard terminology that can be shared among researchers and networks.
• Engage the site in identifying and prioritizing important new research ideas and provide an infrastructure that enables networks to take research ideas quickly from concept to implementation.
• Develop an informatics infrastructure that can be applied and used across multiple networks and provide an integrated electronic repository of tools and programs to assist the site in its study.

"The success of this approach will be measured by how well our networks implement the tools and programs developed, and by how many sites participate in each of the networks," says Harrington.

Key DCRI faculty involved in this study include Drs. Rob Califf, Eric Peterson, and Mark Newman. Suzanne Pfeifer was instrumental in helping secure the grant.

Carol Dukes Hamilton, MD

"Though our specific long-term goal is progress toward worldwide TB control and elimination, the process, connections, and products we develop will have broad application among clinical research networks in the U.S.," says Hamilton. "We will accomplish our goals by collaborating with the DCRI, using their infrastructure, their clinical trials expertise and tools, and their established and developing training programs."

The TBTC-DCRI collaboration will:

• Bring together public health leaders and academic-, foundation-, and pharmaceutical company-based investigators to consider priorities, timelines and needed resources for high priority projects.
• Identify and reduce barriers to clinical trials research in U.S. public health clinics.
• Explore the impediments to expanded use of central Institutional Review Boards (IRBs) in multicenter trials, and address the complexities associated with informed consent among subjects who do not speak English.
• Design a secure Web-based system for capturing TBTC data that is compatible with the systems being deployed by state and territorial public health networks.

Kevin Schulman, MD

Schulman plans to develop an approach to using computerized adaptive testing to collect and assess patient-reported outcomes, such as pain and quality of life, in clinical trials. "To date, little work has addressed when and how these new computerized assessment technologies should be incorporated into multicenter trials," says Schulman. As members of the now-funded Patient-Reported Outcomes Measurement Information System (PROMIS) network, scientists will develop a computerized system to measure patient-reported outcomes more efficiently in study participants with a wide range of chronic diseases and demographic characteristics. Schulman adds, "These new methods bring potential for greater precision and less patient burden, but also for greater logistic complexity and cost."

The study's coinvestigator is Dr. Kevin Weinfurt. Other investigators involved in this study are Drs. Kevin Anstrom, Daniel Blazer, Hayden Bosworth, Rob Califf, Eric Eisenstein, Frank Keefe, Ranga Krishnan, Dan Mark, George Parkerson, and William Richardson.

For more information about the NIH Roadmap Clinical Research initiatives, please visit http://nihroadmap.nih.gov/clinicalresearchtheme/index.asp.