Background

The Mentored Clinical Research Scholar Program of the CTSA (KL2) began in 2006 with the goal of providing relevant didactic and experiential training in clinical and translational research for MDs and MD/PhDs to become independent investigators. Six to eight trainees are supported in any given year, with each trainee receiving 75 percent salary and other support for up to three years. Importantly, trainees conduct research with the guidance of an experienced mentor.

The MCRSP has five major elements:

• First, each trainee will have a formal multi-disciplinary didactic program using coursework taught as part of the Masters of Health Sciences degree at Duke.
• Second, each trainee will have four 3-6 month “internship” rotations through the Duke Translational Research Institute (DTRI), the Duke Clinical Research Institute (DCRI), the Duke Center for Community Research (DCCR) and the Duke Clinical Research Unit (DCRU) to gain insights and experience in some of the key activities along the spectrum of patient-oriented research.
• Third, in addition to learning through coursework, successful future clinical investigators must have high-quality mentoring and opportunities to do significant original work so that they can eventually move to an independent, sustainable academic career. Each trainee supported by this MCRSP will be required to conduct two to three years of full-time research under the direction of a Lead Mentor. In many cases, where multidisciplinary aspects of the proposed work make it advisable, a co-mentor from another discipline will assist the Primary Mentor. Training of participating mentors on the essentials of good mentoring will be an important feature of our program.
• Fourth, each trainee will receive formal instruction in the “survival skills” essential to a successful academic career.
• Finally, each trainee will undergo formal and rigorous training in the responsible conduct of research.

Executive Committee

• John Hamilton, MD, Professor of Medicine/Infectious Diseases and MCRSP Director
• Daniel Mark, MD, Professor of Medicine/Cardiology and DCRI Outcomes Research Director
• William Wilkinson, PhD, Professor of Biostatistics and Bioinformatics
• Lori Bastian, MD, Associate Professor of Medicine/General Internal Medicine

Advisory Committee

The External Advisory Committee of the CTSA
Eugene Braunwald MD, Chair

Resource Organizations

Duke Translational Research Institute (DTRI) - The role of the DTRI is to provide guidance from experienced leadership as well as critical resources and infrastructure for academic translational researchers. It is a "one-stop shop" for studies of human disease and for the early stages in drug, diagnostic and device development. Among the goals of the DTRI are to attract Duke's most talented basic scientists to discuss the potential applications for their research and findings, and to initiate projects that will move their inventions and findings towards human studies, while not slowing their pursuit of basic biological mechanisms and pathophysiology. Another goal of the DTRI is to provide the opportunities for investigators to access the broadest possible platform of technologies that will facilitate biomarker development, mechanistic insight and identification of relevant patient populations for future human studies.

The DTRI houses the following programs/services:

• The Translational pilot project program: Provides funding, project management assistance, and access to technologies and services.
• The MURDOCK (Measurement to understand reclassification of disease of Cabarrus/Kannapolis) Study. The MURDOCK Study is seeking to identify genomic linkages within and across major chronic diseases and disorders. Funding is available to support biomarker discovery and biostatistics and bioinformatics methodology.
• Five technology cores

  Cell and tissue therapies can be developed in a specialized, multi-purpose facility. The MSRB clean suite meets Good Manufacturing Practices and is available to investigators who complete required training.

  Clinical Vaccine Unit focuses on phase I through IV vaccine evaluation and utilization.

  The Imaging core offers centralized access to imaging resources at Duke.

  The Immune Monitoring Laboratory supports various trials and studies, and offers immune monitoring assays, consulting services, centralized specimen processing, data analysis and management, and grant and manuscript assistance.

  The –Omics Core is responsible for the development of a national resource for the spectrum of technologies that includes genomics, genetic polymorphism analysis, gene expression analysis, proteomics, and metabolomics.

Find out more about the DTRI.

Duke Clinical Research Institute (DCRI) - Committed to clinical research of the highest relevance for patient care, the DCRI has evolved over the past 25 years into the nation’s premier academic research organization. It is capable of conducting clinical research projects of any size and has conducted studies in more than 20 different therapeutic areas. It now comprises more than 850 personnel, including 150 faculty members, and has coordinated and completed over 90 multicenter clinical trials. The DCRI provides total study management.

The following services are available through the DCRI:

• Project management
• Communication management
• ECG and imaging laboratories
• Regulatory services
• Safety surveillance
• Site management
• A toll-free 24 hours Clinical Helpline to assist study sites

The DCRI also:

• Houses the Outcomes Research and Assessment Group and the Center for Clinical and Genetic Economics
• Offers a comprehensive fellowship training program
• Oversees the Duke Clinical Medicine Series

Find about more about the DCRI.

Duke Center for Community Research (DCCR) - The DCCR seeks to improve the health of communities by understanding their concerns and helping find solutions to their health problems. The DCCR provides a community participatory research model for obtaining, organizing and analyzing clinical data from a very diverse community that happens to be served by one large medical provider—the Duke University Health System. By linking nearly all health care services in a county of over 200,000 people through a common electronic health record (EHR) system organized to provide aggregate research data, the DCCR is able to rapidly and accurately measure the impact of new technologies and health care strategies on outcomes. In addition to measurement in the traditional sense, DCCR believes that by combining novel approaches to community involvement in the research process it demonstrates how to achieve the "holy grail" of clinical research: embedding the research in practice to optimize the efficiency of the research process. At the same time, the DCCR's community-collaborative approach increases the generalizability of the research and hopefully the adoption speed of new strategies of diagnosis and treatment.

The DCCR comprises:

• Durham Health Innovations: Funded 10 teams focusing on different aspects of community health to work to improve the health of the residents of Durham County.
• The Community Health Research Training Center: an education and training resource for those individuals interested in community research. This center offers graduate level courses, seminars and workshops, technical assistance, formal community health event approval, and cultural competency training.
• The Community Health Liaison Center: Works to educate the community of research and how their needs can be met through research. This center houses a virtual library of successful community research practices and strategies, a listing of organizations at all levels that can provide assistance with community research, and information regarding local service organizations.
• The Community Engagement Consultative Service: Provides an online listing of best community engagement practices and consultative services.

Find out more about the DCCR.

Duke Clinical Research Unit (DCRU) – The DCRU provides intellectual vision and leadership, as well as human and technological resources, to support and promote subject and investigator participation in early phase clinical and translational research. DCRU facilitates studies ranging from investigator-initiated studies of basic human biology, through clinical discoveries, to the design and conduct of sponsored clinical pharmacology and experimental medicine studies in support of drug and device development projects.

The following resources and services are available through DCRU:

Project management
    Biostatistics
    Data management
    Randomization
    Lab sample collection and processing
    Subject recruitment
    Pharmacy services.
    A secure facility that includes:
        Space to accommodate adult or pediatric beds
        Hospital beds
        Outpatient facility
        Metabolic kitchen,
        Specimen collection
        Processing/storage labs
        An Investigational pharmacy.

Find out more about the DCRU.