3 credits, online

This course provides an overview of the drug/biologic/medical device development process, from discovery to mainstream clinical care; and an introduction to the clinical trials process. Students are introduced to the field of translational biomedical research and the sciences upon which it rests—genetics, pharmacology, epidemiology, biostatistics. Roles, responsibilities, professional societies, and career opportunities in the field are discussed. Ethical issues are also introduced.

3 credits, online

Biostatistics for the non-statistician—statistical study design, sample size, statistical analysis plans, and data quality plans. Use of computer systems that help researchers collect, store, organize, analyze, retrieve, and report clinical study information.

3 credits, online

Students become fluent in the language and resources available to gather data on the incidence and prevalence of diseases and conditions needing medical treatment. This knowledge will then be applied to choosing and developing a plan for a product for mitigation of a new disease. The history of epidemics and the effects of modern day medical counter-measures for these events will be studied. We will explore examples of recent emerging infectious illnesses, such as West Nile Virus, and population trends that increase risks for existing illness such as adult-onset diabetes.

Lectures and readings will review government policies in areas where diseases occur and will focus on the effects of these policies on mitigation or spread of disease. Students will learn the differences in health conditions in various economic groups and countries. We will review information from the U.S. Department of Health and Human Services, the Centers for Disease Control and Prevention, professional societies and interest groups such as the American Cancer Society, and the World Health Organization. Our goal is to learn to use methods of access to glean information needed from the huge amount available.

3 credits, online

This course builds knowledge of research methods in this field including: genetic tests — new uses for existing tests and development of new tests, personalized indications (genomic and other) for treatment, how a companion diagnostic is developed in conjunction with a new investigational drug, and the potential for collaboration between diagnostic and pharmaceutical companies. The regulatory aspect of approval of prescreening patients for prognostic genomic markers before entering clinical trials – and having "enriched populations" – focuses on ways of accelerating development of a drug with prescreening testing (smaller, more efficient, cost effective, faster trials) compared with old empiric methods. The adoption of new molecular tests into clinical care and commercial aspects is covered.

6 credits, on-campus and online

Project management concepts and skills are discussed as related to the following aspects of clinical trials: study design, finance, approvals, project initiation, compliance with U.S. Code of Federal Regulations, universal standards, monitoring, auditing, quality control, clinical data management, project management, personnel management, ethical issues, study conclusion, application for and use of patents; managing U.S. and international clinical trials. (Prerequisite: TBRM 500-506)

6 credits, on-campus and online

The course comprises three modules: (1) Advanced biostatistical models of clinical exploration that can lead drugs, devices, or biologic preparations to licensure and availability for patient use; (2) Advanced concepts in informatics, including computerized data collection methods with embedded tables and analysis plans; and (3) Advanced clinical study techniques that allow efficient study execution in appropriate patient groups, including all age groups. Assessment results are translated into clinical trial direction or revision of existing clinical trial plans. All students complete all three modules, and each student completes an individual term project that focuses on one of the above advanced topics, allowing her or him to develop particular expertise in a chosen area. (Prerequisite: TBRM 508)

3 credits, online

Students gain experience with interpreting research findings, drawing conclusions, and verifying that results support conclusions. Students prepare and deliver oral presentations and poster sessions. The experiences in this course enhance the understanding of norms and practices for professional conduct in scientific research. The course focuses on the criteria used to create and evaluate clinical trials reports. (Prerequisite: TBRM 510)

3 credits, on-campus and online

Students integrate knowledge and skills learned throughout the curriculum by applying them to a series of case studies that present typical challenges encountered in the workplace. (Prerequisite: TBRM 512)

6 credits, job site, online connection to instructor, occasional classroom meetings

Each student is placed with an employer (which could be his or her own current employer) for a full semester, during which he or she is given assignments that allow practice with a range of skills required in a translational biomedical research management role. Online class sessions promote shared learning and reflection. (Prerequisite: TBRM 520)