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Overview

Didactic Clinical Research Curriculum: Fellows in the M-RCDP will benefit from classes available through the NIH-supported CCTST program, including research methodology, intellectual property, patents, statistics and bioinformatics, regulatory policies and clinical trial design, conduct and operations. Masters-level programs are also available in translational research, quality and health sciences.          

Mentored Research Experience: Each fellow in the M-RCDP will have a designated mentor and will meet semi-annually with the Career Development Committee to assess progress and opportunities in academic medicine. While the challenges that now face us in training the next generation of clinical and translational researchers are different from those facing bench research, the importance of this training is no less.  The purpose of the M-RCDP is to ensure the continuation of high-quality patient-oriented research training at the HCRI through the provision of opportunities, for post-doctoral trainees who are committed to academic research careers.

The M-RCDP comes at a time when the training methods of the past are no longer enough to provide the insights, skills and knowledge base that future academic leaders will need.  Biomedical science has reached a stage in which its major elements have grown increasingly disaggregated (e.g., cell physiology, signal transduction, molecular genetics, clinical trials design, and outcomes research).  For the tremendous potential of medical science to be converted into true advances in patient care and scientific understanding, these elements must now be reassembled into a coherent and interdependent spectrum.  Future research will require not only medical and scientific expertise, but also increasingly powerful statistical, computational and bioinformatic approaches to extract important information from very large data sets. Indeed, the advances of the future will come from well-integrated multidisciplinary teams of experts working on related aspects of a common problem using data from varying sources.  Finally, the clinical investigator of the future must understand complex infrastructure and operational systems, as well as the vital, but often subtle nuances of ethical interactions with human experimental subjects.  The M-RCDP will employ our most experienced mentors and considerable research resources to prepare new clinical researchers for a successful career in academic patient-oriented research.

The vision of the HCRI is to create an academic environment in which the mission of clinical research is valued highly, its methodology is considered an evolving work in progress, and interactions between biomedical scientists and health professionals are fostered in such a way as to transform fundamental discoveries in the laboratory into medical care that promotes and preserves human health.  Core resources will be leveraged to encourage the collaborative behavior that is essential for success, mentors will be recognized and rewarded, and a carefully crafted educational system will be used to ensure that all participants master a unifying body of knowledge, which they then apply to a highly focused area of research under the guidance of a committed mentor.  Participants in the M-RCDP will be pioneers in this effort to create a system in which senior faculty representing the disparate disciplines of discovery science, translational research, clinical trials outcomes research, and health policy will unite in an effort to create an integrated research system.

Our M-RCDP has five major elements.  First, each trainee will have a formal multidisciplinary didactic program using coursework taught as part of the Master of Health Sciences degree at the CCHMC.  Second, each trainee will have two 1 year “internship” rotations through the Office of Research, including the IRB; and the Clinical Research Institute 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 conduct original work to ultimately secure a sustainable academic career.  Each trainee supported by the M-RCDP will be required to conduct 2 to 3 years of full-time research under the direction of a Lead Mentor.  Training of participating mentors on 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 human research.

There are five primary research tracks that our trainees can enter for their mentored research experience.  Each one has one or more Lead Mentors and there are numerous faculty members at UCCoM and CCHMC who will serve as co-mentors.

 

  1. Bench-to-bedside – Trainees in this area will work primarily in the General Clinical Research Center (GCRC) environment.  Knowledge of basic science is required, but will be focused on early clinical applications.  Research work will often require access to advanced imaging technologies, analyses performed on human blood, cells or tissue samples, and a high intensity nursing environment for complex human studies.
  2. Bedside-to-bench – Investigations in this area are conducted largely in a wet lab environment but are explicitly driven by insights and questions generated from prior patient-oriented research.  For a trainee in this program to elect this track for his or her research, there must be an explicit plan to return to the patient care setting with the insights generated in the laboratory to complete the research program.  Investigators require advanced understanding of disease mechanisms and need convenient access to core resources such a confocal microscopy, mass spectroscopy, and transgenic facilities.  Research may involve specimens from human subjects but is likely also to involve cellular and animal models.
  3. Genomics and Informatics – Trainees in this area may follow either of the bedside to bench or bench to bedside pathways, but will have a special focus on the elucidation of the genetic basis of disease and the manner in which knowledge of human genotypes will influence strategies for disease prevention and management.  Investigators need access to high throughput sequencing and genotyping technologies, gene expression, proteomic and metabolomic profiling technologies, DNA and tissue repositories, and advanced database management, statistical and bioinformatics support.
  4. Clinical Trials – Trainees electing to work in this track need specific knowledge of clinical trial design, data management, statistics, clinical operations, regulatory considerations, business development and contracting with sponsors as well as access to an organization that can manage the complex operations required for both small and large scale trials.
  5. Outcomes/Health Policy/Implementation – Trainees in this area require access to operational capabilities for community and population-based observational studies and registries; ability to assess quality of life, economic outcomes and both implementation and dissemination of advances in treatment; and skill to forge productive relationships with experts in health economics, public policy, law, and business.

 

Outcomes expected from each trainee accepted into our M-RCDP will include presentations at regional and national meetings, peer-reviewed publications, and at least one grant application to support the trainee’s post-program research.  Both the trainee and their Lead Mentor will be held accountable for the outcome of each trainee’s time in the program and both will be carefully evaluated.  The Program Director will assume ultimate responsibility for the success of this program and will use both structured review and unstructured interactions with trainees and mentor to ensure the success of each trainee’s program.  One key part of the program will be periodic review with the trainee by the mentors and Program Director of potential post-training academic faculty positions, so that a smooth transition can be made between training and a faculty appointment or, for existing faculty, scholarly growth that will support the continuation of the trainee’s research career.  The proposed M-RCDP will organize the abundant resources available at the Allied Health Colleges for research into a focused and efficient program for training the clinical research thought leaders of the future.  

Artificial Intelligence Center of Excellence Required Courses

Research Journal Club
Modular biostatistics
Research design
Ethics in Research
Collaborative Institutional Training Initiative (CITI)
Grant preparation training
Advancing public health education

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University of Cincinnati
College of Medicine

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