Expectations and Core Skills
Expectations of Fellows
Although the Fellowship is structured around research that is directly supervised by each individual's mentor, there are several expectations of Fellows. These are summarized below:
- To acquire fundamental research skills through mentored research.
- To attain competency in the areas outlined by the Clinical Pharmacology core skills through structured and informal teaching and self-study.
- To attend all Clinical Pharmacology Grand Rounds and all Fellows Conferences.
- To present at Clinical Pharmacology Grand Rounds.
- To contribute actively to the success of the Program.
Core Skills in Clinical Pharmacology
Key skills and knowledge that are integral to clinical pharmacology have been identified and these are listed below. Courses that are essential are in bold:
- Research ethics and IRB processes
Covers ethics of research, protection of human subjects, protection of privacy, responsibilities of an investigator, the role and function of the IRB, and data safety monitoring.
- Biostatistics and study design
Covers study design, basic statistical methods (parametric and non-parametric), hands on use of SPSS or a similar package, common statistical errors and data presentation.
- Drug regulation and development
Covers history of the FDA, the new drug application and approval process, the FDA Advisory Committee process, drug discovery, biomarkers and outcome measures, intellectual property issues, preclinical testing and early clinical development.
Covers absorption, metabolism and excretion, basic pharmacokinetic calculations, effect of variation in drug metabolizing enzymes and transporters and pharmacogenetics.
- Drug analytic methods
- Basic molecular biology
- Drug safety - surveillance, adverse drugs reactions, drug interactions
- Toxicology and poisoning
- Drug effects and disposition in special populations (elderly, children, pregnancy liver and renal impairment, pregnancy and lactation)
- Writing and reviewing a paper
- Presenting data, teaching skills
- Grant writing and strategy
- Career planning