Program Information

Cincinnati Children’s NIH-sponsored Clinical Pharmacology Fellowship offers trainees the opportunity for in-depth, multidisciplinary learning and mentored research through a two-year program (with a third-year option). Trainees will participate in didactic learning sessions, collaborate with research mentors, engage in professional development activities, and ultimately conduct and publish a research project in a peer-reviewed journal. The overall goal is to prepare trainees to assume leadership roles in pediatric translational and clinical pharmacology.

Program Outcomes

• Complete mandatory training in pharmacology and clinical research, including but not limited to CITI training, NIH Principles of Clinical Pharmacology, NICHD Principles of Pediatric Clinical Pharmacology, and hospital-based clinical research training.
• Demonstrate acquired pharmacology knowledge by teaching select principles during monthly didactic sessions.
• Apply scientific writing skills through development of a grant proposal, study protocol, data collection and analysis procedures, abstract/poster presentations for professional conferences (at least one national conference and one NICHD CPTN annual meeting), and manuscripts for publication in peer-reviewed journals.
• Collaborate with a scholarship oversight committee and research mentor to conduct a research project in translational/clinical pharmacology.
• Participate in professional development activities, including but not limited to attending and presenting at the weekly pharmacometrics lab meeting, monthly journal club, and professional conferences; participating in workshops; and shadowing the Pharmacokinetic Consult Service.
• Develop and maintain an individual development plan (IDP)
• Obtain board certification through the American Board of Clinical Pharmacology (strongly recommended).

Program Activities

In-person Didactics

Fellows are expected to attend the following sessions throughout their fellowship:

• Academic Half-Day, a series of monthly sessions to introduce principles of pharmacology, including basic pharmacokinetics and pharmacodynamics. Faculty provide seminars on topics including pharmacogenetics, pharmacometrics, and pharmacokinetic modeling. These sessions also include an introduction to the clinical laboratory and professional development activities such as writing grant applications, preparing biosketches, searching for jobs, and negotiating start-up packages.
• Pharmacometrics Lab Meeting, a weekly series where fellows, together with graduate students and post-doctoral trainees, present updates on their research projects, answer questions, and solicit feedback from faculty members and attendees.
• Pharmacogenetics Lab Meeting, a monthly series where faculty, fellows and staff gather to discuss progress on pharmacogenetics research studies.
• Pharmacology Journal Club, a monthly series where a fellow, graduate student, or post-doctoral trainee will present a peer-reviewed journal article pertaining to their research interests. The presenter will develop presentation skills and practice generating discussion and critiquing research findings.
• Clinical research training, including topics such as Good Clinical Practice, working with human subjects, responsible conduct of research, and the regulatory role workshop.
• Hands-on experiences, including but not limited to shadowing the Pharmacokinetic Consult Service (performing a supervised consult), DPIC (poison control), Special Chemistry Lab, and IRB.
• Knowledge sharing opportunities with pediatric pharmacology research faculty, students, and fellows at the Children’s Hospital of Philadelphia and Children’s Mercy Hospital of Kansas City.

Online Didactics

Trainees are expected to complete the following within the first year of fellowship:

• NIH Principles of Clinical Pharmacology course, a 30-hour, self-paced lecture series. The fellow will view each lecture and take a self-assessment test.
• NICHD Principles of Pediatric Clinical Pharmacology course, a weekly lecture series available between October and May each year. Trainees must attend at least 75% of the lectures and submit questions to the presenters in order to obtain a certificate of completion. (Fellows will attend this course throughout their fellowship.)

Optional Didactics

Fellows may enroll at the University of Cincinnati in relevant graduate courses, such as Research Ethics or Epidemiology, or degree programs, such as Clinical and Translational Research, Biostatistics, Pharmacogenomics, Drug Development, and Public Health.

Research Activities

Fellows’ research projects will focus on their particular areas of interest in pediatric pharmacology and predictive translational medicine. The fellow will work with the research mentor to identify a research question. Clinical fellows may rely on their specialty experience to develop a project, while non-clinical fellows may collaborate with physicians to develop projects that answer translational questions that can be applied to patient care.

All fellows are expected to assume a leadership role in developing their projects, such as developing specific aims, writing a study protocol, preparing standard operating procedures, submitting documentation to the IRB, forming a scholarship oversight committee, designing the study, conducting the study, collecting and analyzing data, and drafting the manuscript. Throughout this process, the SOC and mentor will meet with the fellow regularly and provide constructive feedback.

Resources

Cincinnati Children’s is a 700-bed pediatric teaching hospital and the area’s only Level I pediatric trauma center. The organization’s administrative arm for research is the Cincinnati Children’s Research Foundation, with a strong record of NIH research funding and approximately 1.5 million square feet of contiguous research space. This space includes shared facilities supporting a wide range of research activities, such as DNA sequencing, single-cell genomics, AAALAC-accredited animal facilities, innovative imaging equipment, and technology transfer.

The Office for Clinical and Translational Research provides researchers with comprehensive support services, research tools, personnel, and facilities for pediatric clinical research studies. The OCTR can assist with all aspects of clinical research, including the preparation of Investigational New Drug applications to the FDA.

The Division of Translational and Clinical Pharmacology has four full-time and four affiliated faculty members, all of whom have strong connections to faculty in other divisions to facilitate multidisciplinary projects. The administrative space includes the Pharmacometrics Center of Excellence, which has advised in numerous studies and investigational new drug applications to the FDA.

In addition to faculty mentors’ research laboratories, the division has 1,300 square feet of laboratory space with standard equipment to support drug analyses as part of pediatric PK/PD studies. The Division has assay development support through the Mass Spectrometry Core Laboratory and the Special Chemistry group, both of which are affiliated with the Division of Pathology and Laboratory Medicine.

Cincinnati Children’s also offers the Genetic Pharmacology Service, a multidisciplinary initiative to develop and implement novel pharmacogenetic testing into pediatric patient care. Its extensive testing history and assay development helps the service meet its goal of educating health care providers about the benefits of pharmacogenetic testing.

Cincinnati Children’s is affiliated with the University of Cincinnati College of Medicine, which offers coursework opportunities as well as the Health Sciences Library, ranked number one among medical school libraries in Ohio.