Didactic Curriculum

CTM 5096 Special Topics

This course is designated for independent or group study as directed by a faculty instructor and approved by the Program’s steering committee and faculty directors. [FALL, SPRING, SUMMER] (1-3 credit hours)

CTM 5097 Directed Research

Research and writing efforts guided by the trainee’s scientific mentor(s) and Program leadership. Deliverables will be reviewed and approved by Program leadership. [FALL, SPRING, SUMMER] (1-15 credit hours)

CTM 5105 Ethics in Clinical and Translational Research

Introduction to ethical reasoning and related processes, techniques of settling disagreements among people, treatment versus research, informed consent, clinical research relevant to third parties, dealing with unexpected scientific and clinically important findings, getting what you want from mentors, consent and risk issues with unproven biological markers, conflicts of interest/duty, handling misconduct and fraud, ethics of subject recruitment, compensating for injuries or medical errors in research, talking to media, public policy advising, authorship order and publications, gender and ethnicity in sciences careers. [FALL of odd-numbered years] (1 credit hour)

CTM 5106 Grant Writing and Funding Strategies

This course will review the different types of federal grant mechanisms as well as grants or contracts from research foundations, advocacy organizations, and industry. How to write a persuasive, well-reasoned application will be the main focus of the course, including the budget, resources and environment, preliminary data, and the research plan. [FALL] (1 credit hour)

CTM 5111 Translational Science Forum

This seminar provides an open community-based opportunity for early-career clinical investigators to improve their skills in clinical research design and analysis and in the presentation of research plans and data. Participants will achieve this goal by mastering key aspects of the thinking process of clinical research in a lighthearted, but critically analytical environment. Expert panel members will ask the presenter general and specific questions about all aspects of the research proposal and provide lively critiques of the substance and style of the research proposals. [FALL, SPRING] (1 credit hour)

CTM 5114 Preparing a Journal Report

Included are general writing skills and strategies; preparing an empirical article, including tips on writing the abstract, introduction, aims, methods, results and discussion/conclusion sections of a peer-reviewed journal article. Students are required to submit a journal article and review others’ articles. [FALL] (1 credit hour)

CTM 5115 Clinical and Translational Research from Proposal to Implementation

Basic elements of a research proposal and implementation are covered. Topics include regulatory approvals; continuing regulatory oversight; monitoring patient safety; recruitment; clinical assessments; data treatment, data collection, entry, and auditing; provision of experimental tests/tasks; data analyses; and publication planning. [FALL] (1 credit hour)

CTM 5118 Successfully Obtaining an R (SOAR) Grant Writing Seminar

SOAR is designed to increase NIH R-type grant acquisition success rates in basic, translational, and clinical research. SOAR includes topics such as demystifying the grant writing process, grantsmanship, surviving the NIH study section review, writing tips and tricks, navigating NIH requirements, peer-review, etc. [FALL, SPRING] (1 credit hour)

CTM 5119 K Grant Writing Seminar

This seminar is intended for trainees who are writing and submitting K grants. Participants attend each session, engaging in a peer review of each other’s specific grant section. Faculty experts are brought in to enhance the learning experience. [FALL, SPRING, SUMMER] (1 credit hour)

CTM 5209 Practical Clinical and Translational Research Proposal Development

This covers defining and developing a research question; distinguishing between correlative and mechanistic questions; matching methods to questions; understanding bias and confounding, random, and systemic error; quantifying clinical information. Additionally, practical aspects of research protocol conceptualization and development are covered. Enrollees have the opportunity to learn how to translate a research question into a hypothesis; how to identify and describe hypothesis-appropriate study subjects and study measurements; select a specific study design appropriate to the research question and resources available; synthesize the elements into a study plan; and develop a statistical section and analytical plan. Protocols developed by enrollees form the primary basis for group discussions. [SPRING] (2 credit hours)

CTM 5203 Clinical Pharmacology and Drug Development

Included are pharmacokinetics; pharmacodynamics; drug absorption, distribution, metabolism, and elimination; drug-drug and drug-disease interactions; preclinical drug development (Phase I, II, III and IV); proof-of-concept and dose-finding studies; post-marketing surveillance. [SPRING of odd-numbered years] (2 credit hours)

CTM 5207 Introduction to Patient Centered Outcomes and Comparative Effectiveness Research

This course covers the methods used in outcomes and health services research, which include research design, theory, measurement, methods of analysis, and evaluation of published research. Course objectives are to: 1) Describe basic concepts, definitions, and types of outcomes and health services research; 2) Understand structure, process, outcomes and underuse, misuse, or overuse of conceptual models; 3) Identify common approaches and challenges in measuring cost, quality, access, and equity in health and health care; 4) Describe experimental and observational research designs used to assess the impact of health services (drugs, devices, procedures, strategies, delivery, and financing systems) on patient-oriented, clinical, and resource-use outcomes. [SPRING] (2 credit hours)

CTM 5208 Essentials of Management and Leadership for Researchers

This course is a structured review and discussion of the basics of management and leadership theory and practice. Topics include project management and budgeting, information systems, leadership style, effective interviewing and hiring techniques, conflict resolution, and the basics of organizational culture. Predominant theories and research, as well as shared experiences of the instructor and the group, are discussed in order to enhance each participant’s effectiveness as a manager and leader. Several hours are spent throughout the course understanding and analyzing federal and state health policy (current and proposed) and the implications for the independent researcher. The curriculum combines assigned readings, didactic lectures, active group discussion, a mid-term project, and a final examination. [SPRING] (2 credit hours)

CTM 5210 Developing and Commercializing Biomedical Research

This course reviews basic concepts in developing and commercializing research in biomedical sciences. Students will learn principles of designing experiments for clinical and regulatory relevance, discerning inventions from research data, obtaining intellectual property legal protection, structuring licenses of inventions to existing companies, forming new start-up companies, attracting investment capital, and regulatory approval of products for human therapy.

CTM 5301 Introduction to Principles and Methods of Clinical and Translational Research

This class presents basic and intermediate principles in research design; formulation of the research question; identifying primary and secondary hypotheses; use of control groups and pre-specified hypotheses; surrogate measurements; analysis of incomplete data; meaning of P values and confidence intervals; and identification of bias and flaws in study design. [FALL] (3 credit hours)

CTM 5302 Biostatistics for Clinical Science II

Topics to be considered are linear and logistic regression models (control of confounding and predictive models); categorical data analysis (binomial and Poisson distributions); analysis of paired categorical data; nonparametric methods for ordinal data; survival analysis (Kaplan-Meier curves, hazard functions, types of censoring, log-rank tests, and generalized Wilcoxon tests, Cox regression model). [SPRING] (3 credit hours)

Prerequisites: CTM 5391 or 5309

CTM 5307 Epidemiology for the Clinical Investigator

This course offers considerations such as concepts of multivariate causality; criteria for establishing causality; risk; rates; incidence, prevalence and attack rates; incidence density; crude, specific and adjusted rates; relative risk, odds ratio, case-fatality rate and attributable risk; sampling error, selection bias, information bias, definition bias and confounding; statistical techniques to control for bias; variables; overview of statistical analysis; multiple comparisons correction; study designs to avoid bias; survey and sample selection, cross-sectional, cohort, case-control; prospective versus retrospective; attributes of cohort studies; design principles of case-control studies; types of control groups; strategies of matching in case-control studies; experiential introduction to statistical computing for different types of clinical epidemiology studies. [SPRING] (3 credit hours)

CTM 5309 Biostatistics I

This course includes a conceptual approach to statistical analysis of biomedical data; review of fundamental statistical principles, focusing on explanation of the appropriate scientific interpretation of statistical tests rather than the mathematical calculation of the tests themselves. The course covers all topics typically used in biomedical publications (data description, summary statistics, p values, non-parametric tests, analysis of variance, correlation, regression, statistical power, and sample-size estimation). [FALL] (3 credit hours)

Socratic Curriculum

The highly innovative Socratic curriculum complements the didactic curriculum. The Socratic curriculum consists of a rich selection of seminars and workshops, conducted using an interactive approach to provide continuous opportunities for clinical investigators to exchange ideas, apply knowledge, present and defend their work, critique the work of others, and participate in forums mimicking real-life conditions of peer review.

5XXX Foundations of Clinical Trials

This course is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of patients.

Translational Science Forum

Weekly presentations of research proposals to a peer group audience by early-career clinical investigators with lively critiques of substance and style by a panel of senior clinical investigators, with the intent of making key points of interest to all investigators.

Navigating CT Science Academic Careers

This workshop focuses on important issues for junior faculty, for example: negotiating for protected time, equipment, resources, promotion, salary, achieving career milestones, surviving in academic medicine, and other career-building topics.

Responsible Conduct of Research

This seminar examines regulatory requirements of clinical research (IRB, GCP, HIPAA, and investigational filings); ensuring patient safety; interactions with government and industry; contract negotiations; successful strategies and tactics. This meets the NIH requirement for training in RCR.