CTSA

About the CTSA

Read about the CTSA Award to Case Western Reserve University here.

Below are the CTSA components at Case. Click on each one to learn more about the broader picture of the CTSA in Cleveland:

• Clinical Research Unit
• Practice-Based Research Networks
• Community Engagement
• Regulatory and Bioethics
• Design and Biostatistics
• Education and Training
• Pilot Grant Program
• Translational Methodologies

The National Institutes of Health awarded $64 million to Case Western Reserve University on September 18, 2007, in partnership with the Cleveland Clinic, University Hospitals and MetroHealth Medical Center, to become part of a national consortium designed to transform how clinical and translational research is conducted, ultimately enabling researchers to provide new treatments more efficiently and quickly to patients.

The consortium, funded through NIH's Clinical and Translational Science Awards (CTSAs), was formed in 2006 with an initial 12 academic health centers located nationwide. The ultimate goal of the CTSA in Cleveland is to provide full service and integrated clinical translational research capability within the Cleveland community that will improve the health of patients in Northeast Ohio through patient-based research.

"We will capitalize on the existing strength of research at Case Western Reserve University in partnership with our hospital colleagues to ultimately provide full service and integrated clinical translational research to improve the health of all of our patients and community," said Pamela B. Davis, dean and vice president for medical affairs of the Case Western Reserve University School of Medicine and principal investigator on the CTSA.

"When it is fully operational, the CTSA will offer each research participant resources that span the range of support for technology-intensive studies that require the resources of our academic medical centers, to local practices and to the Cleveland community itself."

The CTSA has been awarded to Case Western Reserve and three of its hospital affiliates, the Cleveland Clinic, MetroHealth Medical Center and University Hospitals Case Medical Center (a partnership between case Western Reserve and University Hospitals); and include three existing General Clinical Research Center (GCRC) facilities, a successful multidisciplinary institutional K-12 program, substantial technological and statistical core facilities that currently exist in sols; and the institutions' famous practice-based research networks.

In addition, the affiliate will create net resources, including community partnership resources, a new coordinated bioinformatics infrastructure, a new M.D. - Ph.D. program in clinical research, and coordinated resources in bioethics and regulatory support. An academic home for clinical research, the Center for Clinical Investigation, directed by Davis, will provide the career development support necessary for clinical investigators.

Cleveland Clinic, University Hospitals and MetroHealth Medical Center cover 90 percent of the medical care delivered in the seven-county area of Northeast Ohio and offer ample clinical research opportunities. In addition, several programs are based within Case Western Reserve's Frances Payne Bolton School of Nursing, School of Dental Medicine and the Case School of Engineering. In addition, the School of Medicine and its hospital partners reach into the community at many sites, some of which will become study areas in the CTSA.

"Translational and clinical research are the pathways linking new knowledge to medical advances to benefit our patients," said Richard A. Rudnick, vice chair of the Neurological Institute at the Cleveland Clinic and CTSA co-principal investigator. "The CTSA will transform the clinical research enterprise in Cleveland by training leaders for the nation's clinical research enterprise by promoting collaborative research efforts across our region and by developing advanced research infrastructure."

The CTSA initiative grew out of the NIH commitment to restructure the clinical research enterprise, one of the key objectives of the NIH Roadmap for Medical Research. Funding for the CTSA comes from redirecting existing clinical translational programs, including Roadmap funds. When fully implemented in 2012, the initiative is expected to provide more than $500 million over five years to 60 academic heath centers.

Read more about the grant and the CTSA program.

Case Daily, 17 September 2007

Back to "About the CTSA"

The Clinical Research Unit (CRU) facilitates and implements a wide range of human participant research with bi-directional community involvement and education throughout greater metropolitan Cleveland. The CRU accomplishes this through an ongoing series of competitive resource allocations to support investigators undertaking projects that require direct participant and community interaction. The CRU make possible translational studies across the entire spectrum of disease evolution: at-risk populations, diagnosis of disease, therapeutic interventions, and the evaluation of outcomes. This aspect of the CTSA is transforming our existing productive Cleveland GCRCs into cooperative and cohesive Clinical Research Unit (CRU). Community engagement through the active participation of, and our interaction with, the Community Research Partnership Core, particularly its Project REECH (Research Engagement for Community Health) defined in the Community Research Partnership Core, and representation by both community providers and residents on the major CRU governing committee enrich the relationship between the researchers and the diverse community they serve. Thus, CRU has its home within the Cleveland community and academic centers, extending resources to community-based colleagues. Incorporating our successful Practice-Based Research Network (PBRN) provides critical expansion of our existing infrastructure, which allows research in community practice settings where most people receive their continuity care. Thus, there is access to the full range of patient populations for clinical and translational research studies, and patient voice within the clinical research enterprise.

The implementation of our CRU model brings the following advantages:

• Simplified investigator "navigation" and access to CRU resources through the Investigator Concierge Service
• Access to appropriate and relevant training sites.
• Provision of a synergistic network of expertise allowing professionals across institutional and community sites and facilities to interact and seek opinions and guidance, leading to higher quality scientific outcomes.
• Unified systems, standardized research work flow processes, and common reporting tools will enable informed resource allocation decisions.
• Greater capacity and opportunity that will create economies of scale, promote the efficient use of existing human and physical resources thus enabling more science to occur than any single entity could produce.
• Our new structure continues to support an environment that embraces a "customer satisfaction" orientation. Current CRU "customers", researchers and research participants, will now be expanded to include the community. The customer-centric focus demands an individualized understanding of the investigators' needs, the participants' interactions, and protocol requirements ensuring that the designed and delivered services are appropriate. Increased community engagement by the CRU will be accomplished through multiple community engagement programs coordinating with the Community Partnership Core but including specific CRU-directed community interactions.

The availability of combined resources is designed to attract junior-faculty level researchers who are not well established with ready-resources of their own. Tapping into physical space, equipment, lab analyses, participant recruitment contact and trained multidisciplinary personnel will provide momentum for study execution and accelerate completion that will ultimately provide more rapid benefits for healthcare.

SPECIFIC AIMS of the CRU

1. To continue to provide outstanding, controlled inpatient and outpatient environments and core services for clinical and translational research data collection at the most effective cost, and to expand these services with new programs such as the Biospecimen core and Physician Liaison service.
2. Transform into a cohesive CRU inclusive of community members, and community colleagues with a simplified governance to nurture research, allocate and reallocate resources in response to investigator and community need, and to expedite and facilitate investigator access to resources through participation in the Investigator Concierge service.
3. To provide expanded, innovative, and responsive resources and settings for patient based research by:
   
   • Establishing new community sites at current health care facilities
   • Supporting and coordinating with the Practice Based Research Networks
   • Supporting and coordinating with the Community Research Partnership
4. To facilitate the utilization of the vast CRU resources by multidisciplinary investigators, especially those in training or early in their investigative careers.
5. To ensure a culturally sensitive and welcoming clinical research environment home that actively seeks community participation - both of community residents and health care providers - into the development of the research agenda.
6. To markedly enhance and expand participant recruitment activities to expedite study enrollment and completion.
7. To publicize and promote the comprehensive CRU resources beyond the academic medical center

Back to "About the CTSA"

The Research Participant Resource spans the continuum of studies that require resources of the academic medical centers (CRU) and studies conducted entirely in or initiated by the community. In this spectrum, Practice-Based Research Networks occupy a critical central position, integrating the perspective, diverse patient populations, and community ties of medical, dental, and nursing practices outside the Academic Medical Center, and represent a target. Our institutions and community partners are especially strong in PBRNs. We are building on this strength to make it available to clinical investigators.

SPECIFIC AIMS

The Roadmap and Clinical Practice Networks

The NIH Roadmap calls for: "networks of investigators who are equipped with tools to facilitate collaboration and information sharing…The Clinical Research Networks facet of the Re-engineering the Clinical Research Enterprise Roadmap promotes and expands clinical research networks that can rapidly conduct high-quality clinical studies that address multiple research questions."

This important aspect of the Roadmap can be met by supporting Practice-based Research Networks that have been emerging as community-based "laboratories" for clinical research.

Practice-Based Research Networks

Practice-based research networks (PBRNs) have emerged as a critical existing infrastructure with great potential for further development to serve as the 'laboratory" for clinical and translational research in community practice settings where most people get most of their care most of the time61. These community-based clinical laboratories address many of the research objectives of the Clinical Research Networks Roadmap initiative. PBRNs are widely valued for their access to the full range of patient populations needed for clinical and translational research studies, and for their ability to bring the community practice and patient voice to the clinical research enterprise. Case has been a regional, national and international leader in the development of PBRNs and in their involvement in clinical and translational research.

Aims

Therefore, building on more than a decade of experience with NIH-funded clinical and translational research in multiple successful PBRNs, we aim to:

1. Expand local and regional PBRNs, build translational research linkages for PBRNs, and develop methods and supportive technologies for clinical and translational research;
2. Catalyze the generation and application of new knowledge at the front lines of clinical practice; and
3. Train a new generation of transdisciplinary PBRN clinical and translational researchers.

Back to "About the CTSA"

A community may be defined based on a common geographic area such as a neighborhood, a shared identify such as a racial group, or a shared set of values such as a religious denomination. For the purposes of this application, we consider our community to be residents of greater Cleveland. This community is both very diverse and very poor. About 54% of Cleveland's population is African-American and 8% is Hispanic. Cleveland also has a poverty rate of 32% and was recently named the poorest large city in the country. At the same time, Cleveland is blessed with some of the country's most prominent academic medical centers, which conduct innovative peer-reviewed clinical and translational research. This circumstance - highly research intensive academic medical centers in the midst of substantial diversity and poverty - emphasizes both the critical need and the extreme opportunity to meaningfully engage Cleveland's communities in research efforts.

Levels of community engagement

Community engagement in research may be categorized into three levels. In Type 1 research, the academic researcher is the sole inquirer. He/she determines the questions to ask and defines the range of acceptable answers. In Type 2 research, community members provide input in defining the research questions, but academic researchers still determine the methods of inquiry and the range of answers. In Type 3 research, community members and academic researchers jointly define the research questions, determine how to answer the questions, and decide how to disseminate or act on the findings. While all three types may be considered to be community or population-based research, only Type 3 research is referred to as community-based participatory research. Another important distinction relates to the involvement of community residents vs. community organizations. Researchers conducting community-based research may engage communities by interacting directly with community residents or with community organizations or associations. This Community Research Partnership Core will facilitate and enable Type 1 research, but will concentrate on Types 2 and 3 research that will engage both community residents and community organizations.

The CTSA proposes novel approaches to engage communities and to provide researchers with training and resources to conduct community and population-based research. Separate components of the CTSA's Research Participant Program describe the Clinical Research Unit (formerly the GCRC's), and the Community Practice Based Research Networks (in which community-based health care providers are engaged in practice based research networks designed to address questions relevant to their own patients and practices). All 3 programs - the Clinical Research Unit, the Community Practice Based Research Networks, and the Community Research Partnership - are designed as a continuum and will be integrated at the programmatic and management levels to achieve a spectrum of research activity ranging from the medical center to the community, all meaningfully engaging community members.

Specific Aims

The central objectives of the Community Research Partnership Core are to enhance community knowledge and involvement in research and to provide researchers with training and resources in community-based research. Although individual faculty and institutions in Cleveland have pursued some of these objectives, this proposal will dramatically accelerate this process by developing new programs and infrastructure and by integrating community representatives into research efforts.

Aim A. To engage greater Cleveland's communities in bi-directional long-term relationships that will: (a) enhance public knowledge about research; (b) educate academic investigators about community needs and perspectives; and (c) involve communities in setting research priorities, recruiting subjects, monitoring research efforts, interpreting results, and disseminating findings.

Aim B. To provide researchers with training and resources in community and population-based research, with particular emphasis on the principles of cultural competency, community-based participatory research, and dissemination of findings.

Back to "About the CTSA"

Ethics and regulation of scientific research are inextricably linked. The CTSA has made the strategic decision to couple these components in a distinct program that will ensure that the relationship between ethics and regulation is consistently at the forefront of our clinical research enterprise. The regulatory structure that has evolved in this country is based on the critical ethical imperative to protect human research participants from research risk. We also recognize that there exists an ethical imperative to conduct research for the betterment of public and individual health. These two competing ethical imperatives coexist in constant tension, and that tension plays out at the level of protocol design, patient recruitment, IRB review, privacy, and informed consent. Data safety monitoring boards, NIH study sections, conflict of interest committees and even responsible leaders of the popular media constantly struggle with this ethical tension. All stakeholders are faced with the challenge of balancing the need to protect human participants from research risk and the need to provide the public with improvements in health and scientific technology. These two often conflicting requirements create a tension, and this tension indicates a need to reach a balance between the two imperatives.

Although the underlying ethical foundation of regulatory structures for research are generally recognized as essential to the scientific enterprise, unfortunately, too often there is a tendency to emphasize the regulatory over the ethical. Yet, many regulations governing research are derived from key ethical values articulated in the Belmont Report, and those values must be the lens through which regulatory policies are interpreted. The Belmont Report outlines three foundational principles of research ethics: 1) respect for persons; 2) beneficence; and 3) justice. These principles represent the enduring values upon which the research enterprise is based, and research regulations activate these values through specific requirements and standards. Therefore, the function of this program is to resist the temptation to separate regulation from ethics. In doing so, we will facilitate clinical/translational research, protect human participants, and promote public trust through the early integration of ethical considerations in the design of the CTSA's research, education and community outreach activities.

SPECIFIC AIMS

The overall objective of this program is to build integrity into the clinical and translational research enterprise, to enable responsible conduct, and to help our investigators meet regulatory responsibilities. Our approach to this objective is to align bioethics with the regulatory knowledge and support programs; simultaneously providing education, consultation, and guidance in ethical issues related to research while assisting investigators navigate the complex requirements related to regulatory responsibilities. To achieve this overall objective, we propose two specific aims:

1. To transform the Research Subject Advocate Program in order to empower research participants and provide prospective research ethics consultation to all stakeholders in the research process. We will accomplish this aim by developing the Research Ethics Consultation Service (RECS) to help investigators, participants and communities address ethical issues in clinical/translational research.
2. To help investigators meet their regulatory responsibilities. We will accomplish this aim by putting regulatory knowledge in the context of the ethical values that form their basis, by streamlining processes where possible, and by providing individual guidance to investigators on regulatory requirements.

Back to "About the CTSA"

There are several innovative aspects of the proposed Design and Biostatistics Program. First, it is developing an infrastructure of shared resources providing specialized biostatistics expertise under the umbrella of a new Cleveland-wide Design and Biostatistics Core (DBC) made up of the three major medical research institutions in Cleveland, Ohio: Case Western Reserve University (Case)/University Hospitals Case Medical Center (UHCMCMC), the Cleveland Clinic (CC), and MetroHealth Medical Center (MHMC). Although biostatistics support for the three institutions has for the most part been provided independently, two notable exceptions are: a) since 2003, the Biostatistics Shared Resource of the Case Comprehensive Cancer Center, supporting Case/UHCMC and CC, and b) the biostatistics core for the Case/UHCMC GCRC, which supports investigators at Case/UHCMCMC and MHMC. Second, the DBC will work closely with the CTSA Research Concierge Service to provide timely, up-front access to design and biostatistics support to CTSA investigators and promote multidisciplinary translational research by linking researchers from different disciplines. Third, the inclusion of expert teams in specialty areas will facilitate the development and application of innovative designs and analytic approaches for projects designed by CTSA investigators. Finally, while the Clinical and Translational Methodologies Core is the central CTSA home for development of new methodologies, members of the expert teams in the DBC collectively possess a broad range of additional methodological capabilities and can work with investigators on needed methodological problems.

SPECIFIC AIMS

The Clinical Research Concierge Service of the CTSA, with its academic home in the Center for Clinical Investigation (CCI), will serve as the entry point for investigators doing clinical research. A key innovation in this Program is the availability of these services at an early stage of proposal development. The Clinical Research Concierge Service serves as a "front door" to clinical research support services of the CTSA. The concierges match investigators with services and programs available within the CTSA. In particular, investigators will be provided with rapid access to consultation in proper design and analysis, data management, bioethical issues, and regulatory requirements. Statistical consultation is particularly important to investigators as they develop their research projects with the overall goal of promoting multidisciplinary translational research by linking researchers from different disciplines. These consultations will ensure that the specific research questions and objectives are clearly delineated, and appropriate study design, analysis plans, and data management plans have been included. A rapid evaluation of the developing project and provision of appropriate consultation is a critical component of this Program. In addition to the basic services and evaluation that will be adequate for most investigators, it will be important to maintain more sophisticated statistical resources for those who need them. To accomplish these goals, the Design and Biostatistics Program has the following specific aims:

1. Provide rapid biostatistical evaluation of clinical research projects routed through the Investigator Concierge Service.
2. Collaborate with CTSA investigators in innovative design and analysis of research studies, including the development of novel and innovative designs and statistical methodologies.
3. In the course of providing consultation, to educate researchers in topics of research design and
   biostatistical and epidemiologic methods.
4. To develop an infrastructure of shared resources and general and specialized biostatistical expertise under the umbrella of a new Cleveland-wide Design and Biostatistics Core (DBC), including faculty from each of the three major medical research institutions.

These aims expand upon the current biostatistical infrastructure in place at each of the major Cleveland research institutions.

Back to "About the CTSA"

Our Educational and Training Program is designed to educate leaders for the Nation's multidisciplinary clinical and translational research workforce, to accelerate clinical research training, and to educate all members of the clinical research workforce. Building upon: 1) A successful Roadmap K12 program that educates multidisciplinary postdoctoral Clinical Research Scholars; 2) Innovations at the CASE School of Medicine; and 3) Rapidly strengthening collaborations among our medical centers; the CTSA is building a seamless, integrated education network to promote multidisciplinary, team-based education and training within and across institutions. In turn, this Education and Training Program serves our goals of accelerating the translation of basic biomedical research into clinical practice advances, and clinical practice advances into better health at the community level.

The Research, Education, and Career Development Program has three specific aims:

Aim 1: To promote coordinated Clinical Research Education and Training by developing, implementing, and coordinating multidisciplinary clinical and translational research education across partner institutions. The program includes multiple professional disciplines and all members of the clinical research team. Key research competencies will be implemented in all our programs, to include multidisciplinary, team-based research, and cultural competency.

Aim 2: To educate and train a multidisciplinary group of pre-doctoral clinical research scholars in a new Clinical and Translational Scientist Training Program (CTSTP) that will combine PhD training in research with a doctoral degree in medicine (MD), dental medicine (DMD) or nursing (DNP).

Aim 3: To educate and train a multidisciplinary group of post-doctoral clinical research scholars (CTSA K12 Program) to be future leaders for the Nation's clinical research enterprise.

Innovations in the research and education training program are grounded in our successful Roadmap K12 program begun in 2004. We have learned to work seamlessly across institutions and disciplines, and demonstrated that barriers to multidisciplinary collaborations can be surmounted by effective leadership and common vision. The Roadmap K12 program serves as an important and successful "proof of principle" that has convinced us we can develop a much larger trans-institutional educational program within the CTSA. Innovations in this program include:

• We will recruit and motivate young scholars as early as possible to enter clinical and translational science career pathways by conveying a sense of excitement, nourishing their intellectual interests, and instilling a passion for research early in the student's development;
• We will infuse a culture that values multidisciplinary, team-based research by integrating training in teambuilding and leadership education that emphasizes working across institutions and disciplinary silos;
• We will develop combined degree programs in clinical investigation. The Clinical and Translational Science Training Program (CTSTP) will be similar to the Medical Scientist Training Program (MSTP), but will support MD, DNP, and DMD candidates who also seek a PhD in clinical investigation;
• We will implement learner-centered instructional methods such as problem-based learning seminars, miniretreats, and the use of modern electronic media (DVDs, Internet-based curricular initiatives, webcasts) to facilitate accelerated, life-long learning;
• We will provide cultural competency training in collaboration with our Community Research Partnership program.

Back to "About the CTSA"

Effective translational and clinical research requires collaborations amongst multiple disciplines. The scope of such translational and clinical studies is large. Hence, a mechanism that will allow the rapid acquisition of proof-of-principle data to proceed with full-scale investigations is necessary. However, the very nature of such a mechanism poses challenges. Traditionally, pilot funds are limited in both amount and duration. Furthermore, these studies often involve human subjects or human tissues, and so the time to obtain IRB approval can be equal to or longer than the duration of funding. The overall goal of this Pilot Grants Program, therefore, is to function within the CTSA to facilitate pilot and collaborative studies on new research methodologies and new technologies, which will in turn accelerate the process and progress in translational and clinical research based on the potential to positively impact the research enterprise in our institutions.

The Pilot and Collaborative Translational and Clinical Grants Program (the Pilot Grants Program) has the following objectives:

1. To facilitate a broad array of innovative pilot multidisciplinary collaborative projects in translational and clinical investigation, with an emphasis on development or utilization of novel methodologies and advanced technologies;
2. To ensure rapid peer review followed by efficient allocation of funds and rapid start-up of projects;
3. To prioritize pilot projects that:
   • directly address the research agenda of the Research Methodologies and Technologies Program;
   • develop or utilize new technologies and concepts;
   • are multidisciplinary, involving at least two investigators from different fields; and
   • include translational and clinical research trainees
4. To provide mentorship for junior investigators through the period of pilot project funding to ensure the new investigators are well prepared for continued success in clinical and translational research; and
5. To define and track metrics of success that reflect the impact of this program, including faculty promotion and retention, papers, impact at the clinical level, new research/educational programs, manuscripts, national rankings, and extramural funding.

The CTSA Pilot Awards will range from $25,000 per year to $100,000 per year for up to three years, with the following rationale that directly responds to the RFA:

• $25,000/year per multidisciplinary PI (must be at least two interdisciplinary PI's) up to a maximum of $75,000;
• $25,000/year for studies of novel clinical/translational technologies and/or novel concepts; and
• $25,000/year for incorporation of genetics/genomics/epigenomics/proteomics thread or novel phenotyping and outcome measures such as imaging and new clinical measures including selfreporting.

The amount of the pilot and collaborative project award is dependent on the scope of the project, the type of project, as well as the anticipated outcomes (i.e., development and testing of a plan for data collection necessary to make decisions about care pathways via NIH grant application).

Access the application to the Pilot Grants Program here.

Back to "About the CTSA"

A Methodological Research Team (MRT) works collaboratively to develop methods to circumvent well recognized barriers in clinical and translational research. The MRT has developed novel approaches to circumvent bottlenecks in the discovery pathway, from new knowledge derived from the laboratory through to the community. The expertise of MRT members includes statistical modeling, medical imaging, health outcomes research, informatics, business administration, statistical genetics, and genomics. MRT members represent all the participating Cleveland CTSA institutions. This multidisciplinary group began working together prior to the initiation of the CTSA, collaboratively defining the developmental steps in the lifecycle of discovery, and identifying methodologies and solutions. The group has committed to work together as a multidisciplinary team to enrich each other's research, to create academic programs to inform our investigator community about research methodologies, and to reinforce the value of new methods to accelerate the application of discoveries to improve human health.

Specific Aims of the Clinical and Translational Methodologies Program:

1. To make advanced methodologies from the MRT accessible to clinical and translational investigators throughout the CCI and the CTSA;
2. To assist investigators in applying these advanced methodologies for specific research projects; and
3. To collaborate among MRT members, and with investigators in collaboration with the pilot grants program to develop new methodologies to advance clinical and translational science.

Back to "About the CTSA"