Establishing a clinical pharmacology fellowship program for physicians, pharmacists, and pharmacologists: a newly accredited interdisciplinary training program at the Ohio State University

Introduction

The American College of Clinical Pharmacology defines clinical pharmacology as the promotion of the rational use of medications in humans, innovative research, development and regulation of medications, and the education of health care professionals and patients on the optimal utilization of medications.¹ Established in 1991, the American Board of Clinical Pharmacology (ABCP) promotes the discipline of clinical pharmacology, accredits clinical pharmacology training programs, and certifies individual clinical pharmacologists.^2–4 The ABCP awards certification in either Clinical Pharmacology (MD or DO candidates) or Applied Pharmacology (PhD or PharmD candidates) to individuals who have successfully completed rigorous postdoctoral training, and who have met requirements for experience in the field, and who have passed the ABCP examination in clinical pharmacology. Their official website, http://www.abcp.net, details the specific requirements for board eligibility and lists the primary areas of emphasis for the board examinations.⁵ The ABCP also registers and accredits clinical pharmacology training programs⁶ (currently accredited programs are listed in Table 1).

Table 1 Clinical pharmacology fellowship training programs with ABCP-accreditation Abbreviations: ABCP, American Board of Clinical Pharmacology; FDA, US Food and Drug Administration; HIV, human immunodeficiency virus; NIH, National Institutes of Health; OSU, the Ohio State University.

Fellowship programs in clinical pharmacology should offer a multidisciplinary training experience combining didactics, applied learning, independent study, and one-on-one instruction in pharmaceutical science, personalized medicine, general pharmacology, drug development, toxicology, pharmacogenomics, special-populations (including women, children, geriatrics, and members of ethnic minorities) pharmacology, and clinical trial design and regulation. Designed to meet those requirements, the 2 year clinical pharmacology fellowship program at the Ohio State University (OSU) provides an example of a successful, recently established, accredited training program for physicians, pharmacists, pharmacologists, and those with doctoral degrees in other pharmacology-related disciplines. Variety exists among clinical pharmacology fellowship training programs. The program at OSU, however, effectively illustrates the general training components of a 2 year ABCP-accredited clinical pharmacology fellowship program. It provides an adaptable framework for shaping an entirely new program or for enhancing an existing program. Likewise, the program description may be of particular interest to individuals interested in clinical pharmacology and to those considering fellowship training in clinical pharmacology.

Fellowship training year 1

The first year of fellowship training at OSU is composed mostly of didactic learning; fellows are required to obtain a Master of Science (MS) degree in Pharmacology. Courses are taught by faculty members from the Colleges of Medicine, Pharmacy, and Public Health. The required courses in biostatistics, pharmacokinetics, general pharmacology, ethics, and clinical-trial science are described in Table 2. First year fellows are also required to complete additional assessments, certifications, online tutorials, and training in early-phase clinical trials. These additional learning components, listed in Table 3, complement the formal course work and provide comprehensive training in clinical pharmacology.

Table 2 Coursework required to complete the OSU Clinical Pharmacology Fellowship Notes: aA minimum of 30 credit hours is required for the Master’s degree; bpharmacology 7510 is not required for the Master’s degree but is a requirement of the fellowship program; cstudents are required to select one of these courses. Abbreviation: OSU, the Ohio State University.

Table 3 Additional training requirements of first year fellows in the OSU Clinical Pharmacology Fellowship Note: aRequired of physicians only. Abbreviation: OSU, the Ohio State University.

Trainees also participate in the National Institutes of Health (NIH)’s online teleconference course, Principles of Clinical Pharmacology. Covering the fundamentals of clinical pharmacology as a translational scientific discipline focused on rational drug development and utilization in therapeutics, the course comprises a series of approximately 30 weekly lectures, complementing the primary text by Atkinson⁶ and reinforcing the participant’s basis of knowledge for successful completion of a training program in Clinical Pharmacology and potential ABCP certification. Courses are taught by faculty members from the NIH, the US Food and Drug Administration, the pharmaceutical industry, and several academic institutions from across the US.⁷

Fellowship training year 2

The second year of fellowship training involves mostly hands-on learning. Fellows assist in the design, implementation, and direction of a variety of early- and late-phase pharmaceutical trials at OSU’s Comprehensive Cancer Center, pediatric clinical trials at OSU-affiliated Nationwide Children’s Hospital, and lifestyle- and nutritional-intervention clinical trials at OSU’s NIH-sponsored Center for Clinical and Translational Science Research Center. Clinical-experience objectives to be completed during the fellowship are listed in Table 4. Fellows broaden their basis of knowledge in pharmacology while gaining teaching experience as they assist in the instruction of graduate courses in clinical-trial science (Pharmacology 8250 and 8260) and give lectures and workshops to OSU medical students. Learning experiences in pharmacoanalytic methodology and pediatric pharmacology include didactic and independent instruction as well as clinical learning, and these complete the required training of the final year of the fellowship.

Table 4 Clinical-experience objectives for the Clinical Pharmacology Fellowship at OSU Note: aRestricted to licensed physicians. Abbreviation: OSU, the Ohio State University.

Pediatric clinical pharmacology rotation

This 1 month full-time rotation, led by the pediatrics residency director, incorporates didactic lectures, core reading, and clinical experience at Nationwide Children’s Hospital in Columbus, Ohio. Didactic lectures and core reading assignments focus on the following topics: history of pediatric regulations and legislation; assent and consent in pediatric trials; management of adverse events in pediatric trials; balancing risks and benefits in pediatric trials; current trends in pediatric therapeutics, vaccines, and counterterrorism measures; benchmarks in pediatric drug development; physiologic and enzymatic differences between pediatric and adult populations; regulatory differences between pediatric and adult clinical trials; scientific issues relating to the pediatric population, including pharmacokinetics, extrapolation, bridging, safety studies, endpoint analysis and validation; and child growth and developmental issues related to clinical trials. Additional topics addressed during this rotation include pediatric-specific concerns regarding informed consent, protocol requirements, recruitment strategies, scheduling, advertising, coercion, special accommodations, and payment procedures. Clinical experiences during the pediatric rotation focus on current laboratory techniques for pediatric clinical trials, and direct interactions with pediatric patients and their families.

Pharmacoanalytical methodology rotation

This 6 month part-time rotation is supervised by the technical director of the OSU Pharmacoanalytical Shared Resource (PhASR) laboratory. The PhASR laboratory provides investigators with pharmacokinetic and bioanalytical services for preclinical and clinical drug development, and PhASR laboratory activities in experimental design and data analysis primarily support clinical research in the Experimental Therapeutics program at OSU’s Comprehensive Cancer Center. During this rotation, fellows receive training and gain hands-on experience in the design and analysis of clinical pharmacokinetic and pharmacodynamic correlative studies. They become directly involved in various phases of multiple clinical trials in order to gain experience in the following areas: pharmacokinetic study design, drug disposition, pharmacodynamic study design, bioanalytical assay development and validation, supply of drug and metabolite standard materials, individual and population pharmacokinetic–pharmacodynamic modeling, and comparison of preclinical real-time and post-trial data.

During the second year, fellows also attend monthly Pharmacology and Therapeutics Committee meetings at OSU’s College of Pharmacy, weekly Oncology Phase Clinical Trial meetings at OSU’s Comprehensive Cancer Center, and weekly Internal Medicine Grand Rounds lectures at the OSU medical center. Fellows also participate in clinical pharmacology and pharmacy consultations pertaining to drug-dosage adjustments in organ dysfunction and drug–drug interactions. Table 5 provides a list of additional expectations during the Clinical Pharmacology Fellowship.

Table 5 Additional expectations during the clinical pharmacology fellowship

The final component of the Clinical Pharmacology Fellowship is one-on-one instruction focusing on board-preparation for the ABCP certification examination. Major areas which are reviewed include biostatistics, pharmacokinetics, pharmacodynamics, pharmacogenomics, adverse drug reactions, drug interactions, toxicology, therapeutic drug monitoring, clinical trial design and regulation, drug metabolism and receptors, bioanalytical assays, and therapeutics in pediatric and geriatric populations. Goodman & Gilman’s The Pharmacological Basis of Therapeutics⁹ is the primary reference text for both the fellowship training program and board examination preparation.

Conclusion

The fellowship program at OSU exemplifies a multidisciplinary learning experience that prepares clinical pharmacologists for careers in academic medicine, the pharmaceutical industry, or with regulatory or accreditation agencies. Graduates should be board eligible in Applied Pharmacology (PharmDs and PhDs) or Clinical Pharmacology (MDs and DOs) with the ABCP. In addition, physician graduates should be eligible to become Certified Physician Investigators with the Association of Clinical Research Professionals.⁸

The OSU Clinical Pharmacology Fellowship program is continually exploring additional collaborations to provide further experience-based learning opportunities for fellowship trainees. Optional rotations are being considered in nonclinical research at the OSU College of Veterinary Medicine, basic-science research at the OSU Center for Pharmacogenomics, regulatory training by the US Food and Drug Administration, and industry training/partnership with pharmaceutical companies.

Acknowledgments

The authors express gratitude to Eduard Mikulik, MD for his assistance in the instruction provided in our clinical pharmacology fellowship training program. Funding provided by the National Institutes of Health K23 GM100372 helped to support the development of this manuscript.

Disclosure

The authors have no disclosures or conflicts of interest to declare.

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