Clinical and Translational Science Core Courses

Fall Semester

CTS 301Designing Clinical & Translational Research3Kennedy
CTS 305Cell to Society (Semester 1)2Rubin
CTS 310Conducting Clinical & Translational Research3Rubin
CTS 320Analyzing Clinical & Translational Research3Pinckney & Callas

Spring and Summer Semesters

CTS 306
Cell to Society (Semester 2)
CTS 315Reporting Clinical & Translational Research3MacLean
CTS 325
Multivariative Analysis of Clinical & Translational Research3
Pinckney & Callas


CTS Core Course Descriptions

CTS 301 Designing Clinical & Translational Research 

(3 Credits, Instructor: Amanda Kennedy, PharmD, BCPS)

The goal of this course is for participants to learn how to write their own research protocols suitable for submission to an Institutional Review Board or funding agency. Each session covers part of the protocol design process such as choosing a question, picking a design, selecting measurement instruments, minimizing bias, identifying subjects, estimating sample size, designing an analytic plan, avoiding ethical problems, and finding funding sources. Each session includes presentation of a textbook chapter [Hulley SB, et al. Designing Clinical Research: An Epidemiologic Approach, 3rd ed. Williams and Wilkins,Philadelphia, 2006], review of assigned readings from the medical literature, class discussion, and student presentations of their own research protocols. The final sessions are devoted to a mock study section that closely mimics the NIH study section process.



CTS 305/306 Cell to Society I/II

(4 credits, Coordinator: Alan Rubin, MD)

This novel multidisciplinary course, presented over 2 semesters follows the development of a medical intervention from its basic science origins through animal models, early translation to humans, large-scale clinical trials, initial introduction and marketing, to a consideration of the problems of integration into routine practice, late discovery of adverse effects, and cultural and economic barrier to diffusion.


CTS 310 Conducting Clinical and Translational Research

(3 credits, Instructor: Alan Rubin, MD)

This course is designed for new investigators and others wishing to learn the ethics, regulatory requirements, and practical considerations for undertaking a clinical research project. Example topics include: Protecting human subjects; Research with vulnerable populations; Roles, rules, and mechanics of the IRB; Recruitment, compensation, and consent of subjects; Data safety and monitoring; Planning and carrying out surveys and interventions; Conflicts between research and care for individual patients; and, Legal issues in clinical research-authorship, collaboration and conflict of interest. Students will acquire the knowledge and skills to present and defend a proposal before an Institutional Review Board (IRB). The class functions as a mock IRB as it considers proposals and problems designed to illustrate many facets of conducting research. Students present their own protocols before the "Board" as a final class project.


CTS 315 Reporting Clinical and Translational Research

(3 credits, Instructor: Charles MacLean, MD)

This course is designed to develop communications skills for writing, editing, and presenting clinical and translational science. The course prepares students to master five presentation formats: abstracts, posters, brief oral presentations, full-length presentations such as Grand Rounds or seminars, and research reports/journal articles. The course explores American Medical Association standards for publication style and terminology [Iverson 1998] using a text written by experienced clinical investigators [Browner 1999]. The course uses a three-session cycle for each of the five formats. The ethics of publication and the potential conflicts and pitfalls of authorship are also covered.


CTS 320 Analyzing Clinical and Translational Research

(3 credits, Instructors: Richard Pinckney, MD, MPH and Peter Callas, PhD)

This course is designed to provide basic analytical skills for clinical and translational research. Prior clinical research experience is helpful but not required. The course assumes no prior statistical experience and mathematics is kept to a minimum, requiring comprehension at the high school algebra level. Content includes basic data considerations, descriptive statistics, hypothesis testing, and bivariate analyses. Classes provide a small group interactive seminar approach with "hands on" analyses using the statistical software package STATA. Analyses of ample datasets are completed on a weekly basis. Specific datasets are provided, but students are encouraged to bring their own datasets to use throughout the course. Lectures are available online.


CTS 325 Multivariate Methods for Clinical and Translational Research

(3 credits, Instructors: Richard Pinckney, MD, MPH and Peter Callas, PhD)

This intermediate course builds upon the descriptive and bivariate statistical methods presented in Analyzing Clinical Research. Emphasis is on developing the foundational skills and knowledge for using regression analytical techniques based on the correlational aspects of clinical data. The conceptual and applied applications of correlational and regression analyses to clinically relevant research datasets are the focus of the course while keeping mathematics to a minimum of basic college-level algebra. Specific datasets are provided along with encouragement for students to incorporate their own research datasets into the course. Class assignments involve actual computer analyses illustrating the concepts discussed in class while allowing students the flexibility of choosing datasets and variables that are of specific interest.