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Objectives

This postdoctoral fellowship training program will prepare clinician-scientists for research careers in clinical pharmacology. Trainees of this fellowship program will become future leaders in clinical pharmacology research. Clinical pharmacology, in the broadest sense, encompasses drug discovery, clinical development, regulatory issues, therapeutic use and individualization of drug therapy, optimization of drug dosage regimens, an understanding of drug-induced toxicity, and measures to prevent or minimize adverse effects of drugs. This program will include both didactic and experiential training in the methodology and conduct of basic and clinical research necessary to investigate the effects and mechanisms of drug actions in humans, with an emphasis in one of the core research focus areas: Drug Disposition and Action; Quantitative Pharmacology/Pharmacometrics and Clinical Trial Design; Individualized Therapy; Drug-Induced Organ Toxicity. Trainees are expected to demonstrate competency in clinical pharmacology, and develop fundamental competency in research ethics, clinical trial design, biostatistics, and grant/manuscript preparation through required coursework and common core experiences. In addition to coursework, weekly research seminars and the Clinical Pharmacology Forum, a journal club in the trainee’s research focus area, and professional development activities will enable trainees to develop competency in research methods through translational, hypothesis-driven research experience relevant to clinical pharmacology. Trainees will devote a minimum of 80% time to research, under the supervision of Faculty Mentors. Trainees are expected to be well-versed in the philosophy and ethics of scientific and clinical investigation in preparation for successful careers in clinical pharmacology and demonstrate the following core competencies:

  • Formulate an original clinical pharmacology research question
  • Understand and design alternate research strategies and methods
  • Conduct a clinical pharmacology research project, including writing the clinical protocol and consent form for Institutional Review Board review, and learning the appropriate skills for the proper collection, management, storage, and use of data (either primary or secondary)
  • Develop statistical/analytical skills needed to test hypotheses and interpret results in collaboration with biostatisticians/pharmacometricians
  • Master the written and oral communication skills necessary to write a successful grant application focused on a problem in clinical pharmacology, report clinical pharmacology research results in abstracts, posters and podium sessions at scientific meetings, and publish manuscripts in scholarly journals.

 

  • Elements of program:
    • Coursework
    • Professional Development:
      • Grant writing training
      • Written and oral communication training
      • Book club focused on developing skills in conflict resolution, leadership, team management, communication, perseverance, and effective work habits.
      • Opportunities to attend national/international professional meetings or conferences
      • Mentorship of undergraduate, graduate or other students
      • Teaching experience such as facilitating small group discussions, didactic lectures
      • Other professional development activities

 

  • Individual Development Plan:
    • The IDP provides a framework for the trainee to identify both professional development needs and career objectives, and serves as a communication tool between postdoctoral fellows and mentors. An IDP helps the postdoctoral fellow identify both short-term goals for improving performance and long-term career objectives s/he wishes to pursue, and the necessary skills to accomplish these objectives.

 

Coursework

Required Courses

  • DPET 833: Experimental Design Considerations in Clinical Research
    • This is an overview course in clinical trial methodology, focusing primarily on the design of clinical drug trials and non-clinical research experiments intended to answer clinical/translational questions.
  • DPET 853: Pharmacokinetic Concepts and Applications
    • This module is an introduction to pharmacokinetic theory, mathematical model development, and data analysis.
  • NIH Course: Principles of Clinical Pharmacology (Online)
    • This course is an online lecture series covering the fundamentals of clinical pharmacology as a translational scientific discipline focused on rational drug development and utilization of therapeutics.
    • The following core principles of pharmacology are emphasized: pharmacokinetics, drug metabolism and transport, drug therapy in special populations, assessment of drug effects, drug discovery and development, pharmacogenomics, and pharmacotherapy.
    • The lecture series can be accessed at the following link: https://ocr.od.nih.gov/courses/principles-clinical-pharmacology.html
  • Responsible Conduct of Research (RCR) Training
    • Responsible Conduct of Research courses are offered at UNC and Duke.
    • The North Carolina Translational and Clinical Sciences (NC TraCS) Institute offers a 1-week (20 hr) intensive face-to-face course in clinical research for junior faculty members, postdoctoral fellows, and graduate students at UNC each July.
    • In addition, there are semester-long courses at UNC (PHRS 801, Foundations for Cross-Disciplinary Training in the Pharmaceutical Sciences) and Duke (CRP 253, Research Ethics and Responsible Conduct of Research) that are available to postdoctoral fellows in our program.
    • The Collaborative IRB Training Initiative (CITI) is a web-based training package focused on a wide variety of issues related to human subjects research. Completion of the on-line CITI RCR is mandatory for all post-doctoral fellows in our program who are engaged in the planning, conduct, or analysis of research involving human subjects.

Optional Courses

  • DPET 854: Pharmacodynamic Concepts and Applications
    • Introduction to pharmacodynamics from a modeling and simulation perspective.
  • DPET 857: Population Pharmacokinetic/Pharmacodynamic Analysis
    • Introduction to population pharmacokinetic and pharmacodynamic modeling techniques, including theory and application.
  • DPET 858: Advanced Pharmacokinetics/Pharmacodynamics
    • This course covers a series of advanced pharmacokinetics/pharmacodynamics (PK/PD) modeling concepts and techniques, fundamental elements of systems pharmacology, and methodology of developing mechanism-based PK/PD models in drug development.
  • DPET 873: Precision Therapeutics through Genomics
    • This course reviews the principles and applications of genomics to therapeutics and studies examples where this field is impacting therapeutic decisions in a variety of disease states.
  • BIOS 545: Principles of Experimental Analysis
    • Based in the UNC School of Public Health, this course covers the analysis of experimental and observational data, focusing on multiple regression, analysis of variance and analysis of covariance.
  • DPET 831: Quantitative Methods in Clinical Research
    • This course provides an overview of the statistical concepts and methods for analysis of data from clinical research studies and/or experiments.
  • DPMP 815: Drug Metabolism Module
    • Introduction to the use of concepts, chemistry, enzymology, and techniques in drug metabolism for the design and development of safe and effective therapeutic agents.
  • NIH Principles of Pediatric Clinical Pharmacology
    • A weekly webinar series sponsored by NICHD, which is required for trainees with an interest in pediatrics, addresses the fundamentals of clinical pharmacology from a pediatric perspective.
  • BIOL 425 Human Genetics
    • This course covers pedigree analysis, inheritance of complex traits, DNA damage and repair, human genome organization, DNA fingerprinting, the genes of hereditary diseases, chromosomal aberrations, cancer and oncogenes, immunogenetics and tissue transplants.
  • TOXC 442 Biochemical and Molecular Toxicology
    • This course covers biochemical actions of toxicants and assessment of cellular damage by biochemical measurements.

 

Board Certification

  • Clinical pharmacology board certification provides an objective measure of mastery of the discipline of clinical pharmacology. Board certification is through the American Board of Clinical Pharmacology (ABCP) and requires a certification examination and completion of a two-year postdoctoral fellowship training program in clinical pharmacology that is accredited by ABCP.
  • This program meets the fellowship training expectations set forth by the ABCP and is a registered member of ABCP.
  • Diplomates are certified in Clinical Pharmacology (Physicians) or accredited in Applied Clinical Pharmacology (Non-Physicians and Non-licensed Physicians)
  • More information and eligibility criteria may be found at: http://www.abcp.net/