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

Figures & data

Table 1 Clinical pharmacology fellowship training programs with ABCP-accreditation

Program, location	Year accreditation granted by ABCP	Website, program highlights
Baylor College of Medicine Houston, TX, USA	2003	https://www.bcm.edu/departments/medicine/sections-divisions-centers/hypertension-and-clinical-pharmacology/education/hypertension-and-clinical-pharmacology • Research program focuses on regulation of vascular function in health and disease • Clinical rotations include Clinical Pharmacology Research and Diagnostic Clinic, Hypertension and Clinical Pharmacology Consultation Service, and Clinical Pharmacokinetics Core Laboratory at Baylor College of Medicine or Texas Children’s Hospital • Trainee, in conjunction with the faculty in one of several departments or internal medicine divisions within the College, determines an area of interest
Children’s Mercy Hospitals and Clinics Kansas City, MO, USA	2008	https://www.childrensmercy.org/ClinPharmFellowship/ • The only pediatric clinical pharmacology program accredited by the ABCP in the US • Opportunity to conduct research alongside pediatric subspecialist physicians and biomedical scientists committed to the evaluation of pediatric pharmacotherapies • New (2012) pediatric clinical research unit with state-of-the-art facilities for research and clinical trials
Dartmouth-Hitchcock Medical Center Lebanon, NH, USA	2006	No external website, contact [e-mail] • Extensive training in oncology drug development • Research strengths in pharmacokinetic and bioanalytic methodology • Opportunity to participate on Clinical Pharmacology and Toxicology consult services
Indiana University, School of Medicine Indianapolis, IN, USA	2003	http://medicine.iupui.edu/clinpharm/fellowship • Pediatric, obstetric, and general clinical pharmacology specializations • Research strengths in personalized medicine and pharmacogenetics for cancer, HIV, and cardiovascular disease • Seven NIH-funded fellowship positions
The Ohio State University, College of Medicine Columbus, OH, USA	2009	http://www.medicine.osu.edu/pharmacology/graduate-programs/pages/fellowship-programs.aspx • Associated with the Center of Pharmacogenomics, OSU College of Medicine • Instruction, clinical experience, and research are tailored to trainee’s experience and interests • Master’s degree in Pharmacology incorporated into fellowship
Thomas Jefferson Medical College, Department of Pharmacology and Experimental Therapeutics Philadelphia, PA, USA	2006	http://www.jefferson.edu/jmc/departments/pharmacology/education/fellowship.html • Training within a dedicated academic phase I unit • Training experience with a pharmaceutical company, with the editorial board of the Annals of Internal Medicine journal, and with the US Food and Drug Administration • Opportunity to concentrate in adult or pediatric clinical pharmacology
Uniformed Services University of the Health Sciences and Walter Reed Army Institute of Research School of Medicine Silver Spring, MD, USA	2004	http://wrair-www.army.mil/OtherServices_ClinicalPharmacology.aspx • Available to US Army active-duty PhDs/PharmDs and US Army physicians who are board eligible/certified in a primary specialty; civilians can be considered but must join the US Army and successfully compete for their fellowship position • Conduct laboratory, animal, and clinical research under the supervision of a mentor • 3 month rotation at the FDA
University of California at Los Angeles David Geffen School of Medicine Los Angeles, CA, USA	2005	http://icptp.k30.ucla.edu • Broad, interdisciplinary, program focused on clinical pharmacology and experimental therapeutics • Salary support provided through the National Institute of General Medical Sciences (NIGMS) T32 Clinical Pharmacology Postdoctoral Training Program grant • Emphasis is placed on conducting research in special populations, including women, children, geriatrics, and members of ethnic minorities • Clinical research curriculum available as an auditing-only track, a 2 year certificate program in clinical research, or a Master of Science (MS) degree in Clinical Research
University of Chicago, Division of Biological Sciences Chicago, IL, USA	2002	http://ccpp.bsd.uchicago.edu • Clinical and basic research projects in pharmacogenomics, drug development, clinical pharmacology, genetics of drug abuse, and clinical trial design • Core curriculum includes courses in Pharmacogenomics, Personalized Medicine, Advanced Clinical Pharmacology, and Patient-Oriented Research • Experience serving on the University’s Biological Sciences Division Institutional Review Board, Pharmacy and Therapeutics Committee, and Clinical Pharmacology Consultation Service • Three training tracks: Clinical Therapeutics, Clinical Therapeutics in Oncology, and Clinical Therapeutics in Industry

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.

Table 2 Coursework required to complete the OSU Clinical Pharmacology Fellowship

Course	Credit hoursa	Course description	Text
Pharmacology 5600, Introduction to General Pharmacology	3	Online instruction; organ systems approach; focuses on drug mechanisms of action	Lippincott’s Illustrated Reviews: Pharmacology, R Harvey (Lippincott Williams & Wilkins),^Citation10 required
Pharmacology 7250, Pharmacogenomicsc	2	Discussion- and presentation-based; focuses on basic-science approaches for biomarker development and clinical implications
Pharmacology 8250, Clinical Trials I	7	Lecture and discussion based; focuses on clinical trial design and federal regulations	Principles and Practice of Clinical Research by J Galin and F Ognibene (Academic Press),^Citation11 required
Pharmacology 8260, Clinical Trials II	7	Lecture and hands-on-experience based; focuses on clinical trial document preparation and implementation strategies
Pharmacology 7510, Professional and Ethical Issues in Biomedical Sciencesb	2	Lecture and discussion based; focuses on developing and evaluating professional behaviors in biomedical science
Pharmacy 6220, Drug Delivery IIc	3	Lecture based; focuses on pharmaceutical dosage forms, ionization, solubility, and stability
Pharmacy 7310, Clinical Pharmacokinetics I	3	Lecture based; focuses on modeling absorption, distribution, metabolism, and elimination of pharmaceutics and on inter- and intra-patient variability in pharmacokinetics	Clinical Pharmacokinetics and Pharmacodynamics: Concepts and Applications by M Rowland and T Tozer (Lippincott Williams & Wilkins)^Citation12 and Applied Biopharmaceutics and Pharmacokinetics by L Shargel, A Yu, and S Wu-Pong (McGraw-Hill Medical),^Citation13 recommended
Pharmacy 7320, Clinical Pharmacokinetics II	3	Lecture based; focuses on the pharmacokinetic–pharmacodynamic relationship of pharmaceutics
Public Health: Biostatistics 6210, Design and Analysis of Studies in the Health Sciences I	3	Lecture based; focuses on basic data-summary methods, estimation, and hypothesis testing	Fundamentals of Biostatistics by B Rosner (Cengage Learning),^Citation14 required
Public Health: Biostatistics 6211, Design and Analysis of Studies in the Health Sciences II	3	Lecture based; focuses on analysis of variance methods and computer-based statistical methodology

Notes:

a A minimum of 30 credit hours is required for the Master’s degree

b pharmacology 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.

c students 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

American Heart Association Basic Life Support (BLS) certification; case simulation and written examination

American Heart Association Advanced Cardiac Life Support (ACLS) certification; case simulation and written examinationa

American Heart Association Pediatric Advanced Life Support (PALS) certification; case simulation and written examinationa

Standard Operating Procedures (SOP) for Clinical Trial Implementation; written examination

Good Clinical Practice (GCP); written examination

Collaborative Institutional Training Initiative (CITI) course in the protection of human subjects; computer-based examination

Good Laboratory Practice (GLP); written examination

Code of Federal Regulations (CFR); written examination

Environmental Health and Safety Certificate of Completion for Blood-Borne Pathogens; written examination

Health Insurance Portability and Accountability Act (HIPPA) training; computer-based examination

Environmental Health and Safety Certificate of Completion for Lab Standards – 29 CFR; written examination

Notes:

a Required of physicians only.

Abbreviation: OSU, the Ohio State University.

Table 4 Clinical-experience objectives for the Clinical Pharmacology Fellowship at OSU

Witness and conducta dosing of investigational pharmaceuticals

Support the design and submission of clinical study protocols for review by the Institutional Review Board

Obtain medical and medication histories from adult and pediatric subjects and patients

Performa physical examinations for determining participant eligibility

Interpreta electrocardiograms and real-time cardiac telemetry

Obtain informed consent (adults) and assent (children and adolescents) from potential clinical-trial participants

Supervise research staff in the implementation of clinical-trial activities

Collect, process, and store biological samples

Assess, document, and treata adverse events; assist with assigning causality of adverse events

Collect and document data as well as assist with data query resolution

Perform quality assurance checks of source documents and case report forms

Design and implement strategies to recruit patients

Interact and develop professional relationships with representatives from pharmaceutical companies and regulatory agencies

Perform drug preparation, dispensing, and accountability

Supervise and implement laboratory analysis of biological samples

Perform analysis and modeling of pharmacokinetic and pharmacodynamic data

Evaluate standardized study-specific meals ensuring specific caloric and nutritional requirements

Notes:

a Restricted to licensed physicians.

Abbreviation: OSU, the Ohio State University.

Table 5 Additional expectations during the clinical pharmacology fellowship

Write commentaries, abstracts, or manuscripts suitable for publication in peer-reviewed journals

Write investigator-initiated protocols and study-related documents

Write original grant proposals suitable for submission to the National Institutes of Health or private foundations

Attend Institutional Review Board meetings (for both Biomedical Sciences and Behavioral Sciences)

Attend an institutional Health Insurance Portability and Accountability Act privacy board meeting

Participate in monthly journal clubs, presenting and critiquing research relevant to clinical pharmacology

Establish an interactive multidisciplinary network of research and professional collaborators

Explore potential career pathways in academia, the pharmaceutical industry, clinical research organizations, and regulatory agencies

HarveyRAClarkMAFinkelRLippincott’s Illustrated Reviews: Pharmacology5th edBaltimoreLippincott Williams & Wilkins2011

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GallinJOgnibeneFPrinciples and Practice of Clinical Research2nd edNew YorkAcademic Press2007

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RowlandMTozerTClinical Pharmacokinetics and Pharmacodynamics: Concepts and ApplicationsBaltimoreLippincott Williams & Wilkins2010

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ShargelLWu-PongSYuAApplied Biopharmaceutics and Pharmacokinetics5th edNew YorkMcGraw-Hill2004

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RosnerBFundamentals of Biostatistics7th edIndependanceCengage Learning2010

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