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A new $54 million NIH grant is about to reinvent the way clinical research is conducted at
Melissa Begg, co-director, and Henry Ginsberg, director, of the new Irving Institute for Clinical and Translational Research.
Melissa Begg, co-director, and Henry Ginsberg, director, of the new Irving Institute for Clinical and Translational Research.
CUMC. The award is part of the NIH’s Roadmap for Medical Research, which seeks to accelerate medical discovery and improve health.
   The Clinical and Translational Science Award (CTSA), announced in October, will help re-engineer CUMC’s research enterprise from one composed mostly of individuals conducting research focused on a single approach to problem-solving to a model characterized by multi-disciplinary teams who collaborate to transform basic discoveries into new treatments.
   CUMC was one of 12 medical centers to receive the first of these highly competitive NIH grants. By 2012, the NIH expects to have 60 such centers across the country.
   “Effective collaboration and communication are crucial to the research enterprise,” says Lee Goldman, executive vice president and dean. “The CTSA award will allow us to enhance the levels of collaboration, integration, and communication among our scientific community. It is vital to ensuring that CUMC continues to lead, to innovate, and to be a valuable partner with like-minded academic health centers now and into the future.”
   Since the early 1990s, the NIH has tried to address the slowing pace in which new discoveries progress from the bench to the bedside, first with new grant programs to enable more scientists to become clinical investigators, then by increasing money spent on basic research.
   “These approaches didn’t work because they only focused on isolated silos of
scientific activity,” says Henry Ginsberg, M.D., the Irving Professor of Medicine and the grant’s principal investigator. “Translating new knowledge to medical care requires communication and cooperation among different silos, so simply increasing support for the individual components of the process won’t help. The barriers to moving knowledge from one area to another must also be overcome.”
   There are terrific examples of groups at CUMC who have overcome these barriers, Dr. Ginsberg adds, “but we can do more, we must improve and we can restructure a more supportive environment for translational research.”
   The first step in establishing a more supportive environment will be the creation of an academic home for translational research – the Irving Institute for Clinical and Translational Research. Junior fellows and senior faculty across CUMC will be given joint appointments by the Institute. Junior faculty will receive salary and research support, and all faculty will be supported for promotion by the Institute as well as their “home” departments.
   Having a home for translational research will help revamp the path to academic success. “The traditional route to academic success has been narrowly focused research, which has actually been an impediment to translational research,” says Melissa Begg, Sc.D., professor of clinical biostatistics at the Mailman School and co-director of the Institute. “Investigators who remain in a single discipline typically have an easier time publishing papers and are rewarded by their universities with promotions and raises. Translational research often takes longer to publish, and it is often difficult to assign credit to interdisciplinary efforts undertaken by a research team. Providing financial support gives faculty an incentive to engage in translational research.”
   All investigators at CUMC will be eligible for funding in all areas of research through the Institute’s career development and pilot award program for cross disciplinary projects. The Institute will also develop programs to tackle other barriers, including stricter ethical rules for research involving patients, and proper study designs and biostatistical analyses that
The CTSA grant will support clinical and translational research at CUMC
The CTSA grant will support clinical and translational research at CUMC, such as Howard Kaufman’s research on tumor immunology and cancer vaccines.
ensure findings and recommendations are supported by good evidence.
   “A huge amount of work is involved in finding people who can help you design a study, satisfy all the regulations, create a database to collect data, and ultimately analyze the data,” says Stephen Johnson, Ph.D., associate professor of biomedical informatics and leader of the Irving Institute’s Biomedical Informatics group. “This is why a lot of clinicians don’t go into research today.”
   Groups like the Biostatistics Resource at the Mailman School are already available at CUMC to help researchers, but they are scattered and their availability has not been widely recognized by CUMC investigators. The Irving Institute will centralize these resources and make them easier to utilize (see sidebar).
   Expanded training courses and mentoring programs will also provide training in clinical research for young investigators, and new programs will soon be added to give Ph.D. students in the basic sciences a taste of clinical research and doctoral students in the clinical sciences a taste of basic research. In the longer term, a new Ph.D. program to train the next generation of translational researchers will be developed.
   None of these efforts, however, will improve people’s health – particularly in underserved communities – if researchers cannot recruit enough patients into clinical trials. Locally and nationally, fewer and fewer patients participate in clinical trials, often because they are never asked.
   “Hundreds of clinical trials go on at Columbia at any one time, but there is very little community participation,”says Rafael Lantigua, M.D., professor of clinical medicine, who directs the
   Irving Institute’s Community Engagement Resource with Ralph Sacco, M.D., professor of neurology and epidemiology.
   “People in the community want to participate in trials, Columbia researchers want to conduct research in the community, and doctors in the community want to learn how to do clinical research and collaborate with us,” Dr. Lantigua says. Some community outreach programs, such as Dr. Sacco’s Northern Manhattan Stroke Study and Dr. Lantigua’s Columbia Center for Active Life of Minority Elders, have bridged the divide, but other Columbia researchers interested in community health often don’t know where to start. The CTSA will provide resources to increase community-based research.
   By next summer, a new off-campus community research center should stimulate more interaction among researchers, doctors and community residents and will benefit all involved. CUMC researchers can recruit patients and the community can also approach researchers to get help with health issues. “The center will raise our current level of community engagement and the research we do there will undoubtedly improve residents’ health,” Dr. Sacco says.
   “Transforming the way science is conducted at CUMC will not be easy and won’t happen overnight,” Dr. Ginsberg says. “But we already have the ingredients for building an outstanding clinical and translational research program and are confident in our ability to succeed.”

—Susan Conova