University Times

A National Institutes of Health (NIH) multi-million grant to a dozen academic medical centers, including Pitt, hopes to transform how clinical and translational research is conducted.

Pitt is among 12 institutions nationwide to receive an inaugural NIH funding grant to develop and advance clinical and translational science as a distinct discipline, according to NIH director Elias A. Zerhouni, who announced the awards Oct. 3 in a national telebriefing and press conference.

Pitt will be awarded $83.5 million over five years — among the largest NIH awards in the University’s history — to establish the Clinical and Translational Science Institute (CTSI). Of Pitt’s funding, about $53 million will be re-directed NIH funding previously awarded to local general clinical research centers.

“The development of this consortium represents the first systematic change in our approach to clinical research in 50 years,” Zerhouni said. “Working together, these sites will serve as discovery engines that will improve medical care by applying new scientific advances to real-world practice. We expect to see new approaches reach underserved populations, local community organizations and health care providers to ensure that medical advances are reaching the people who need them.”

Barriers between basic and clinical research, declining interest in research as a profession and public distrust of research impede the translation of new findings into the clinical setting, NIH officials said.

Zerhouni said the new effort is directed primarily at chronic diseases, which now consume three-quarters of the nation’s health care resources.

The prime goal of Pitt’s institute is to ensure that biomedical research advances expeditiously find their way into clinical practice, according to the grant’s principal investigator Steven Reis, Pitt associate vice chancellor for clinical research, who will head the CTSI.

“NIH proposed this initiative to include the translation of research from bench to bedside and from bedside into practice,” Reis told the University Times. “By definition this is a multi-disciplinary institute. We will be working with the Heath Sciences schools, Carnegie Mellon University, UPMC, Western Psychiatric Institute and Clinic (WPIC) and community partners such as the Urban League of Pittsburgh.”

Within the first few years of funding, the CTSI will begin training a new cadre of clinical scientists, starting with programs at the high school level, he said.

Pitt also plans to establish a minority health clinical and translational research center at UPMC Braddock, he said. “We’ll also put in a trial program to work with the Urban League of Pittsburgh to put clinical research staff in their headquarters so that we can have educational programs but also potentially to do screenings and straightforward or less-intense clinical research studies out in the community.”

The Rand Corp. will evaluate the institute’s progress toward its goals, he said.

At the start, the CTSI will provide secondary appointments for researchers, Reis said. “We will be working with deans at the Health Sciences schools to incorporate participation in clinical and translational research into the promotion process, for instance,” he said.

“We will essentially have an open door policy to bring researchers together ranging from basic to clinical to public health, and provide resources to perform different kinds of translational research,” Reis said.

Pitt’s CTSI has 10 key components, including a pilot funding component and an education component that will establish a clinical research education program ranging from high school students to the PhD level, Reis said. Pitt also will extend its master’s degree program in clinical research to a doctoral program, he said.

The institute will develop novel clinical and translational methodologies, such as a clinical research registry, among the first of its kind in the world.

“We’re going to infuse biomedical informatics into every aspect of clinical research, ranging from fostering collaborations using IT, to supporting the nuts and bolts of clinical research,” Reis said.

For example, an open-source software system called Diamond, jointly created by Intel Research and Carnegie Mellon, will allow CTSI researchers to scan and search large volumes of images rapidly.

Institutions in the new consortium are required by the NIH to “build academic homes for clinical and translational science” through an infrastructure that would consolidate their existing resources with new initiatives.

Creating a new “academic home” for the Pitt institute will include integrating local general clinical research centers into the CTSI community, Reis said.

“These are primarily in-patient facilities that serve as resources for research, so that there are projects that are performed at Montefiore, WPIC, Magee and Children’s Hospital that will be coming under the CTSI umbrella, and their NIH funding will be redirected there,” accounting for $53 million of the overall grant, Reis said.

The CTSI comprises four main areas:

• Education and career development, which will be headed by Wishwa Kapoor, Falk Professor of Medicine, professor of health policy and management and chief of the Division of General Internal Medicine at Pitt’s medical school;

• Translational research, headed by Robert A. Branch, professor of medicine and pharmacology, director of Pitt’s Center for Clinical Pharmacology and chief of the medical school’s Division of Clinical Pharmacology;

• Clinical research, which Reis will direct, and

• Clinical and translational bioinformatics, which will be directed by Michael Becich, professor of pathology and director of Pitt’s Center for Pathology Informatics.

The community partnership program will be led by Jacqueline Dunbar-Jacob, dean of the School of Nursing.

In addition to consolidating clinical and translational research resources infrastructure, institutions in the consortium are being asked to:

• Develop better designs for clinical trials to ensure that patients with rare as well as common diseases benefit from new medical therapies;

• Produce enriched environments to educate and develop the next generation of researchers trained in translating research discoveries into clinical trials and ultimately into practice;

• Design new and improved clinical research informatics tools;

• Expand outreach efforts to minority and medically underserved communities;

• Assemble interdisciplinary teams that cover the complete spectrum of research — biology, clinical medicine, dentistry, nursing, biomedical engineering, genomics and population sciences, and

• Forge new partnerships with private and public health care organizations.

Other recipients of NIH Clinical and Translational Science Awards are Columbia University Health Sciences; Duke; Mayo Clinic College of Medicine; Oregon Health and Sciences University; Rockefeller University; University of California, Davis; University of California, San Francisco; Penn; University of Rochester; University of Texas Health Science Center at Houston, and Yale.

Fifty-two other centers received planning grants to help them prepare applications to join the consortium.

The clinical and translational science awards initiative grew out of NIH’s commitment to re-engineer the clinical research enterprise.

The national consortium will be led by the National Center for Research Resources, part of NIH.

Funding for the awards initiative comes from redirecting existing clinical and translational programs. Total first-year funding for the awards announced last week will be approximately $100 million.

When fully implemented in 2012, the initiative is expected to provide a total of $500 million annually to 60 academic health centers.

—Peter Hart