How We Do It

Biomedical Informatics

Managing information is crucial in all phases of research, beginning with study conceptualization, proceeding through protocol execution, and ending with results dissemination. The University of Rochester Clinical and Translational Sciences Institute (CTSI) will support the informatics needs of clinical and translational investigators through the provision of specific services and through the development of novel informatics tools. Specifically, the Biomedical Informatics Program of the CTSI will carry out four types of activities. First, it will promote the use of existing informatics resources and coordinate their use through broad-based communications and individual consulting services. Second, it will integrate existing informatics resources and provide additional resources, over time developing a local information infrastructure. Third, it will facilitate data sharing and the dissemination and re-use of process-based knowledge by developing and implementing informatics standards and protocols, both within the UR-CTSI and in cooperation with other regional collaborators. Finally, it will assess and optimize informatics services, individually and as an integrated system, by evaluating their actual use in clinical and translational research, by soliciting user feedback, and by evaluating their impact on the process of research translation from bench to bedside and bedside to curbside. The result will be an optimized, integrated biomedical informatics infrastructure which will facilitate the rapid translation of new discoveries to clinical practice.

Community Engagement

The transformation of biomedical research requires the development of a true continuum from bench to community. Communication and collaboration among the major sectors of the health community – the academic community, the practice community, and the public health community—are essential to improve the community’s health and overall quality of life.

The University of Rochester Clinical and Translational Sciences Institute (CTSI) seeks to build new and sustainable communications channels among these key segments and to promote grassroots community participation in clinical and translational research. Its Community Engagement function, which is administered by the URMC’s Center for Community Health, provides the infrastructure to support the CTSI community engagement mission by facilitating communication and genuine partnerships among investigators, health care providers, and community members. The Community Engagement function contributes to a more active clinical and translational research environment and greater participation by the local community.

Design, Biostatistics, and Clinical Research Ethics

Professional methodologic support is critical to the proper design, execution, analysis, interpretation and application of clinical and translational studies. The University of Rochester Clinical and Translational Sciences Institute (CTSI) will provide scientific leadership and expertise in the areas of epidemiological, biostatistical, and ethics methodologies as they relate to the design, conduct and analysis of observational and experimental studies. Four specific services will be offered. First is the provision of detailed consultation for the development of study protocols. Second is the provision of necessary biostatistical, epidemiologic, and ethics support during the conduct of studies. Third is collaboration with investigators in the interim and final analysis of study data, which includes all phases of analysis such as pinpointing appropriate statistical methodologies, programming, analysis and interpretation of results. Fourth is the development of novel research methods to handle unique problems in statistical analysis, computational biology, bias and confounding, risk profile modeling and ethical considerations. In addition to serving the needs of clinical and translational investigators, the CTSI will conduct methodologic research in epidemiology, biostatistics and ethics. As a result of these contributions, CTSI faculty and trainees will be well-poised to promote interdisciplinary interactions and scientific cross-fertilization.

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 date.

Novel Clinical and Translational Methodologies

CTSI Administrative Committee

In order to overcome roadblocks inhibiting the translation of basic science discoveries from the laboratory to interventions that can be tested in human subjects, it is necessary to develop novel research methodologies. The University of Rochester Clinical and Translational Sciences Institute (CTSI), through its Novel Methodologies function, will take advantage of ongoing and new collaborations among basic and translational researchers to increase the speed with which new methods are developed and broaden their scope of application. Specifically, the CTSI will encourage the development of new methodologies by soliciting proposals for new methodologies and approaches; providing support for especially promising proposals; and establishing travel grants to allow investigators to learn new techniques at other institutions. The CTSI will take the next step by promoting the use of new methodologies by providing key information about new methodologies in a variety of widely-accessible forms; and evaluating the applicability of new methodologies as part of the standard review of proposed protocols by the General Clinical Research Center Advisory Committee. Finally, the CTSI will assess on an ongoing basis the research needs of its investigators and proactively address them through a tailored RFA-like process. Approximately $175,000 per year will be available to support successful proposals. Through these mechanisms, the CTSI will be in the forefront of developing new clinical and translational research methodologies and disseminating them to stimulate new substantive research.

Participant and Clinical Interactions Resources

Translational investigators require dedicated facilities and the support of individuals with specialized skills to carry out patient-oriented research successfully. The University of Rochester Clinical and Translational Sciences Institute (CTSI) provides the ideal environment for patient-oriented studies. In particular, the Clinical Research Center (CRC), a unit of the CTSI, provides the following necessary support. First, the CRC provides space, skilled nursing and bionutrition staff, and other laboratory services. Second, the CRC fosters collaboration between clinical, translational and basic science investigators by making information on ongoing studies available through a web-based inventory and through the efforts of a new Associate CRC Program Director. Third, the CRC expedites protocol initiation through specific training programs, dedicated staff assistance, and the co-location of administrative support functions in the CRC. Fourth, the CRC encourages and facilitates participation of volunteer subjects by locating the CRC in a new, accessible location, providing financial support for subject travel expenses, and providing child care services in the CRC. Fifth, the CRC maintains a cadre of skilled research coordinators and will coordinate their availability to CTSI investigators on a cost-sharing basis. Finally, the CRC will promote the introduction of novel research techniques for patient-oriented studies through ongoing seminars. This constellation of accessible support services in a dedicated environment will ensure that investigators overcome the challenges attendant to clinical and translational patient-oriented research.

Pilot and Collaborative Studies

Preliminary and proof-of-concept studies are often critical first steps in moving basic laboratory findings into clinical applications, yet funding for such studies is scarce. The University of Rochester Clinical and Translational Sciences Institute (CTSI) and its Pilot and Collaborative Studies function will catalyze innovative clinical and translational studies by providing a number of flexible funding mechanisms for pilot studies. The CTSI will support three types of proposals. The first type includes projects that generate crucial preliminary data to support the submission of new clinical and translational research proposals. The second type includes proof-of-concept studies seeking clinical applications for basic science findings. The third type includes stimulation of new cross-disciplinary collaborations, within the institution and with other institutions. Approximately $200,000 per year will be available to fund such studies. The ultimate result will be an increase in the number of novel clinical trials deriving from basic science discoveries.

Public-Private Partnerships

The Public-Private-Partnerships (PPP) Key Function (KF) leverages several efforts to identify programs and foster external research collaborations with potential partners from state and federal government agencies and laboratories, the private sector, and academia. The Director of Research Alliances at the University of Rochester directs the key function. Broadly, the PPP KF has the following goals:

1) Develop research and educational collaborations; increase awareness of areas of translational research and regulatory science programs and policies; and provide insight on approaches to engage federal agencies, the private sector, and other academic partners;

2) Participate in and lead national CTSA Consortium initiatives and other external efforts to identify and enhance opportunities for research and educational collaborations;

3) Engage the University of Rochester regional technology commercialization and business development affiliates, identifying opportunities for the CTSI to partner with these organizations and support regional initiatives.

Research Education, Training and Career Development

The overall goal of UR-CTSI Research Education, Training and Career Development key function is to develop an integrated program that has the breadth and flexibility to meet the needs of new investigators who are committed to careers in clinical and translational science and who require additional knowledge and skills to contribute to multidisciplinary teams of investigators. Flexibility will be enhanced by organizing predoctoral, postdoctoral, and career development programs to meet the needs of trainees at a range of career stages. This key function has initiated and oversees two Master’s programs (in Clinical Investigation and Translational Research) and a Doctoral program in Translational Biomedical Science. These new educational modules are integrated with existing clinical research training modules, related doctoral programs, skill-building workshops, and seminars to provide the flexibility to meet the needs of investigators across the spectrum of disciplines needed for successful translational research.

Additionally, the program operates a predoctoral (TL1) training program using the new curricula, skill-building workshops, seminars, and mentored research experiences leading to an advanced short-term research track for medical students (MD-MS degree), a graduate program leading to a PhD in Translational Biomedical Science, or an MD-PhD Program for trainees interested in clinical and translational science. This key function has initiated and operates a Clinical and Translational Research Career Development (KL2) Program tailored to fellows and junior faculty members’ needs through didactic curricula leading to Masters or PhD degrees, skill-building workshops, and mentored experiences in clinical/translational research. Finally, it has expanded the mentor development program to enhance the quality and quantity of mentors in translational and clinical research who can meet trainees’ needs for research mentorship in short term, graduate (Masters or PhD), or career development programs.

Regulatory Knowledge and Support

Eric Rubinstein and Edward Schwarz

New investigators face a number of challenges in beginning a research career, including the need to learn about the science and ethics of human subjects research as well as the regulatory requirements that are relevant. Established investigators need to stay up-to-date as requirements change and best practices are established. The University of Rochester Clinical and Translational Sciences Institute (CTSI) and its Regulatory Knowledge and Support function will provide researcher-focused and translational research-specific support for regulatory compliance and management. Such support will fall into five specific categories, as follows. First, the CTSI will ensure that researchers receive the training necessary to optimize study design, regulatory review and the informed consent process. Second, the CTSI will conduct quality improvement and good clinical practice guideline audits to provide investigators with real-time guidance and support. Third, the CTSI will develop an education and assistance program, using a blend of computer-assisted and in-person delivery mechanisms. Fourth, the CTSI will oversee conflicts of interest to ensure that they are appropriately managed or eliminated. Finally, the CTSI will share services and best practices with the members of the Upstate New York Translational Research Network (UNYTRN) and the National CTSA Consortium Steering Committee. These carefully designed and implemented programs will result in more efficient regulatory review and enhanced subject safety.

Translational Technologies and Resources

The future of medicine demands increasingly specific knowledge of pathophysiologic mechanisms to drive improvements in health care. Clinical and translational investigators frequently require access to specialized technologies and equipment. Making good use of the equipment demands substantial expertise. The University of Rochester Clinical and Translational Sciences Institute (CTSI), through its Translational Technologies and Resources function, will facilitate access to key resources for clinical and translational research, and invest in state-of-the-art facilities. Specifically, the CTSI will establish a laboratory support center, which will promote collaborations between investigators and core resources at the University, assist investigators in accessing these laboratories, and monitor the progress of supported projects. In addition, the CTSI will establish a translational technology subsidy for new projects deemed highly meritorious. Finally, the CTSI will upgrade the physical infrastructure at the institution and support selected technologies that are expected to have broad applicability for enhancing clinical and translational research, including animal and human imaging, genomics and proteomics. Greater access to technological expertise and resources will accelerate the advance of translational research at the institution.

UNYTE Translational Research Network

The overall goal of the UNYTE Translational Research Network is to facilitate access to technologies, facilities, services and expertise among member institutions, in order to promote collaboration between investigators at those institutions and to reduce resource duplication. Particular emphasis will be applied to enhancing bidirectional transfer of knowledge between bench scientists and clinical investigators throughout the network. UNYTE will create inventories of research projects and research resources across member institutions. It will establish a set of working groups to advance network capabilities with regard to regulatory compliance; human subjects issues; study coordination, recruitment and retention; translational research informatics; clinical research centers; study design and analysis; and research education and training. It will fund pilot projects that involve collaboration among two or more network members.

 

NIH Funding Acknowledgement ** Important ** All publications resulting from the utilization of CTSI resources are required to credit the CTSI grant by including the NIH FUNDING ACKNOWLEDGEMENT and must comply with the NIH Public Access Policy.