Senior Clinical Research Fellowships
Core Curriculum and Shared Resources
Core Curriculum
Courses: In addition to the NIH-Duke University Program, fellows are encouraged to take courses on Principles and Practice of Clinical Research (offered by the Clinical Center), Clinical Pharmacology, and Ethical and Regulatory Aspects of Clinical Research Course (offered by the Department of Clinical Bioethics, Clinical Center), all of which meet once a week for several months during the year.
Seminar Series: Monthly seminars by invited speakers, either from intramural programs or extramural institutions. The speakers are clinical investigators with national reputations in patient-oriented research. The fellows run the seminar series with consultation from faculty advisors. This activity and a Fellows Presentation (see below) will be combined in an alternating format.
Fellows Presentation: Monthly meeting; fellows take turns in presenting their research (does not have to be completed work; can be work-in-progress) or interesting topics of their choice (can be in the format of a clinical-pathological conference).
Journal Club: Monthly meeting; covering clinically important publications of the specialties; focused on patient-oriented research and evidence-based medicine; rotate among fellows.
Research Project: The fellows will choose a mentor in the subspecialty of their interest to pursue a clinical research project. This can be done either before or in the middle of the fellowship. This will be mostly a one-on-one relationship that should consolidate and intensify the on-hand training in designing, conducting, completing and presenting a patient-oriented research project.
Faculty Advisory Committee: consists of NIDDK Fellowship Director, two clinical faculty members outside the Branch of the mentor, and a more senior fellow in the program, who will meet twice a year with the fellow and/or mentor to evaluate progress and address issues.
Grant Writing
Given the disease-related nature of the proposed research, the areas of investigation will likely be in the mainstream of medicine and thus in line with the missions of a number of different organizations. It is highly recommended that the idea of obtaining outside funding support from private foundations (e.g., Juvenile Diabetes Research Foundation International, American Liver Foundation), voluntary health agencies (e.g., American Diabetes Association), and professional societies (e.g., Endocrine Society, American Gastroenterological Association) be explored.
In addition, such studies are extremely relevant to the pharmaceutical-biotechnology industry in the private sector and so formal relationships through Cooperative Research and Development Agreements (CRADA’s) and perhaps other support mechanisms will be examined through NIDDK’s Office of Technology Transfer.
Senior Clinical Research Fellows can take advantage of the two Grant Writing Workshops that are already being offered to all Fellows at NIDDK through the Fellowship Office as part of its on-going commitment to career development. These courses include “Grant Writing 101: Introduction to the Basics” and “Grant Writing 102: Dissecting a Grant Application – The Art of Crafting Your Proposal.” The latter is a rather technical approach geared toward submitting applications for R01 Grants and K08/K23 Career Development Awards.
Development of a Sense of Identity-Community Among Clinical Researchers at NIDDK
The construction of institutional infrastructure that supports the work of clinical investigators will foster cohesion within the group. Examples of this include:
- Formation of a Data and Safety Monitoring Board (with invited non-NIH investigators)
- Initiation of quality assurance/quality improvement for infrastructure development and maintenance
- Formation of a Clinical Studies Office responsible for the maintenance of the infrastructure and for facilitation of audits
Undoubtedly, the common space that is equipped with electronic and hard copies of reference material (biostatistics, controlled clinical trials, pharmacology) shared by all investigators and clinical fellows will lead to productive and mutually beneficial interactions. Lectures and Rounds that highlight the common aspects of clinical research and encourage sharing of subspecialty expertise will also facilitate this goal.
Partnerships with Other Institutes and Centers
Clinical investigation requires the expertise of many individuals working together. It is anticipated that the need for expert consultation or co-investigators will occur commonly during protocol development at NIDDK. This will foster partnerships with other Institutes and Centers at NIH. Presently, the Endocrine Training Program has a successful track-record in this area with excellent, long-standing relationships with the National Institute of Child Health and Human Development (NICHD), National Cancer Institute (NCI), and National Institute of Dental and Craniofacial Research (NIDCR).
The configuration of the patient units in the Mark O. Hatfield Clinical Center will also facilitate the interaction of clinical investigators from various institutes. One novel partnership may be for institutes sharing the patient care units to share the cost of an Informationist to assist in literature searches for protocol development, patient care, and the like.
Dedicated Space: Overview of New Clinical Center
- Mark O. Hatfield Clinical Research Center. This is a new, state-of-the-art hospital scheduled for occupancy in the fall of 2004. The facility will have 240 in-patient beds, 90 day hospital stations, and outpatient clinics of an Ambulatory Care Research Facility. All these clinical activities will be in contiguity with research laboratories, an arrangement that fosters taking ideas from bench-to-bedside and back. The Clinical Research Center is planned to promote translational research – the process of transforming laboratory research into applications for the benefit of patient care.
- Senior clinical fellows will be assigned offices in the new Clinical Research Center, the Ambulatory Care Research Facility, or in the original Clinical Center. Efforts will be made to cluster staff according to medical disciplines and common interests in order to maximize opportunities for development of collaborative clinical research initiatives.
- Ample conference rooms for small and large groups with state-of-the-art communication and imaging facilities are available.
- Opportunities for staff interactions are also fostered by a Cyber-Café facility and several common areas with pleasant surroundings for informal meetings and discussions.
Core Facilities/Shared Resources
Given the complexity and multidisciplinary nature of clinical investigation, senior clinical fellows with the support of their mentors will have the opportunity to collaborate with various clinical research support personnel including:
- Nurse practitioners for patient management
- Research nurses for acquisition of data
- Patient care coordinators for scheduling of patients and procedures
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Statisticians for assistance in design and analysis of clinical studies
- Informatics specialists for assistance in optimizing data instruments and analysis of databases
Clinical laboratories: Facilities for specimen collection, sample processing and storage are available in areas contiguous to inpatient and outpatient facilities.
