Email this pageBarriers to Research: Solving a National Problem
New Institute Would Smooth the Road From Discovery to the Clinic and Patient
Glenn Rechtine, M.D., wanted to conduct a study of a new drug that could bring enhanced, longer-lasting pain relief to people who undergo spinal surgery. He had the support of the manufacturer, including free access to the drug and a $50,000 grant to keep records and track the results.
"Patients would benefit from this. The Medical Center would benefit. It could have been straightforward," said Rechtine, a spinal surgeon and a faculty member of the Department of Orthopaedics.
But it took Rechtine about two years to launch the trial as he encountered a series of bureaucratic and resource obstacles typical of what researchers around the country often face.
Clinical and translational research have become more complex and cumbersome to initiate as regulations, costs, and information demands increase. The regulatory controls are necessary. But the National Institutes of Health wants to re-engineer research, utilizing innovative and efficient ways to conduct studies of new drugs and medical devices, navigate regulatory systems and reduce time delays for researchers. To accomplish this, Rochester’s School of Medicine and Dentistry will establish a Clinical and Translational Research Institute. The goal of the Institute is to make the research machine run better and more efficiently – by identifying barriers and coming up with solutions, new solutions. That could mean a new way to fund highly experimental research, new techniques to conduct epidemiological research, new technology to analyze complex medical results, and even new ways to make sure trial volunteers are protected. Rochester’s Institute will smooth the road between novel ideas and application in clinical trials and patient care. The School of Medicine already has a Research Review Process Improvement Team working with researchers who are preparing to launch trials.
Rechtine's experience illustrates the issues. During his two-year effort to get his study underway, Rechtine spent a significant amount of time dealing with the legal requirements designed to protect the institution in case the study ran into difficulty. After he secured the needed approvals, he then had to search for a coordinator to oversee the nuts and bolts of the trial.
"If, as a nation, we are serious about clinical or translational research, we need to make it easier for busy clinicians to participate," Rechtine said. "It's difficult for clinicians who see patients to find the extra time to deal with these things. Doctors trying to do a study in addition to seeing patients would welcome additional resources to tackle the job."
Sharing Resources
Rochester's Clinical and Translational Research Institute will establish a centralized system to aid researchers and provide financial support.
Investigators sometimes develop novel technologies for a specific area of clinical research that could be useful to other researchers – but the researchers often don't know about it or there is no system that makes the connection.
For example, Edward M. Schwarz, Ph.D., associate professor of orthopedics and of microbiology and immunology, and his lab group are experts in imaging technology, which they use to determine the relationship between inflammation and the longevity of artificial joints. They have developed innovative computer techniques for analyzing data from CT scans.
"Could those techniques be applied to other problems in clinical research, such as understanding autoimmunity or developing more effective immune modulating drugs?" said John Treanor, M.D., an infectious disease expert and professor of medicine, microbiology, and immunology.
Likewise, Tim Mosmann, professor of microbiology and immunology and director of the David H. Smith Center for Vaccine Biology and Immunology, has a program to develop novel methods to assess human immune function.
"With the Clinical and Translational Research Institute, we might be able to facilitate moving that technology to other areas of clinical research, like the research we are doing to enhance the immune response to bird flu vaccines, or perhaps research being done in the Center for Future Health related to the effects of aging, or work in the Department of Psychiatry on the effects of stress and social networking on health," said Treanor.
"Think of the inability to answer an important question because the techniques needed to address the issue are lacking. The solution could be matching the investigator with an existing technique in a new application, facilitating the modification of an existing technique or developing collaboration between investigators to develop a new technique. It's actually more difficult than it sounds," Treanor said. "At the core, it's a problem of communication. Trying to increase the visibility of what other researchers are doing within the broad university community is an important part of it. Finding ways to provide appropriate administrative resources to clinical researchers will be another way to remove barriers. The new institute can do both."
Judith Baumhauer, M.D., professor of orthopaedic surgery, looks forward to more resources for research. She is involved in an industry-sponsored trial of a bone-graft product, a mix of platelet-derived growth factor and calcium carbonate that could be used in foot and ankle fusions or some serious fractures.
A trial requires a coordinator who must understand the complex details of the research and who can address many issues. These include completing the documents required by the board that reviews a trial's patient-protection procedures, establishing a system for budgeting and billing, and meeting with monitors from the Food and Drug Administration who inspect trial operations. The coordinator also arranges medical procedure appointments for participants.
Baumhauer had to turn to the Department of Orthopaedics to fund and hire the coordinator.
"It was difficult to find the right person for the job, and even then she had to learn the process under fire," Baumhauer said. "I can't possibly do all of these things myself. This kind of research requires very specific resources. It's crucial to get it right."
The Institute, a central resource for coordinators, funding and for other research needs within the Medical Center, would help more clinicians conduct trials and other studies. As more studies are more efficiently initiated and completed, the potential increases for safe innovations moving from the lab to the patient – the primary goal of NIH's reengineering project.
Rochester's Key Aims
The new Clinical and Translational Research Institute will have an impact on virtually everyone who conducts research at the Medical Center, bringing new and better organized ways of support, education and communication. The Institute's key aims include:
Novel Translation Methodologies: Develop new approaches that address roadblocks to translational research. The concerns range from intellectual property protection issues to cell identification and imaging tools for medical outcome validation. Solicit proposals from within the University and from scientists and industry in Western New York. Provide support for especially promising proposals. Disseminate information on novel developments and resources throughout the University and Upstate network, using a standing website and an electronic newsletter that would highlight developments in research methodology in an easily accessible manner.
Pilot Studies: Fund pilot projects that generate data to support novel clinical trials, test ideas for clinical applications for basic research discoveries or stimulate cross-disciplinary collaborations. The pilot awards would range from $5,000 for organizing a research conference or $10,000 for a "mini-sabbatical" visit to a laboratory or clinical site to $25,000 for training and $50,000 for targeted research.
Biomedical Informatics: Survey and analyze current biomedical informatics, clinical trials technology and services that facilitate the storage, retrieval, sharing and use of data, knowledge, and other resources. Integrate existing resources and develop new functions so they will constitute a local and centralized information infrastructure for clinical and translational research. Develop standards and protocols to support data sharing within the institute and with the external collaborating organizations. Provide professional consulting regarding all aspects of technology for the conduct of clinical translational research. Create an education program to assist researchers. Develop novel methodologies to enable the conduct of clinical research and advanced data analysis.
Design, Biostatistics, and Ethics: Provide consulting services in biostatistics, epidemiology and ethics necessary to design and conduct clinical and translational studies. Assist with the interpretation of the results of analyses, production of final reports and graphical displays and preparation of presentations and manuscripts for publication. Develop research methods to handle unique problems in the areas of statistical analysis, bioinformatics and computational biology, bias and confounding, risk profile modeling, and ethical considerations in translational research. Create improved ways to design clinical trials and analyze results, and new biomathematical methods for the analysis of gene arrays and gene regulatory networks that impact on cancer, genetic conditions and other human diseases.
Regulatory Support: Ensure that researchers are trained in the science and ethics of research involving people as volunteer subjects. Organize a dedicated unit of specialists in translational research who will be assigned to support investigators in regulatory and safety issues in order to optimize study design, regulatory review and the informed consent process.
Patient and Clinical Interactions: Designate a senior-level investigator to encourage collaboration between basic scientists and clinical researchers. Organize a clinical research coordinator's office. Expand the role of the Research Subject Advocate. Increase mentoring program to encourage the career development of translational investigators. Hire additional nurses to support studies. Promote research subject participation through the provision of new services, such as transportation and child care.
Community Engagement: Establish long-term partnerships with community organizations and engage community leaders assure community input into research priorities and strategies and to promote participation in clinical and translational research. Create office to coordinate practice-based research networks, which are groups of physicians and their staffs throughout the region. The practices will contribute to selection of research issues and take part in research, including studies of disease trends, health disparities and use of new therapies or technology in the community. Develop community-based recruitment and retention plans to increase individual participation in studies and trials. Design investigator training programs in community health engagement.
Translational Technology: Appoint a faculty-level director to seek out technological barriers to research and find ways to help investigators succeed in finding and accessing laboratory services and technology. Provide money to investigators to defray a share of laboratory service costs. Upgrade the labs, technology resources, and personnel that can enhance clinical and translational research.
Education and Career Development: Create novel training programs, including two new Master's degree programs, in clinical investigation and translational research, and a new Ph.D. program in translational biomedical sciences. Expand a mentor development program to enhance the quality and quantity of mentors in translational and clinical research. Develop skill-building workshops, seminars, mentored research experiences and other training programs in translational research for medical students, fellows, junior faculty, and others.
Upstate Network: Organize a consortium of 10 biomedical research institutions in the Upstate New York region into a regional network for translational research. This organization will be administered through an independent foundation, the Foundation for Healthy Living, in order that all partners can take advantage of the network's shared resources. Develop inventories of translational research at member institutions, and of research resources that can be used for collaborative research. Assist members with regulatory compliance, including providing training in ethical issues and volunteer safety. Support pilot projects involving two or more network members. Utilize regional marketing and training to recruit people for research projects.
Evaluation: Incorporate tracking and evaluation into all institute activities. Develop model methods for project evaluations. Assess, on an annual basis, the achievement of institute goals through review and analysis of collected evaluation data.