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Rutgers SHP Requirements for Graduation and Course Descriptions

Department of Health Informatics

Clinical Research Management

BPHE5500 - Multiple Analyses in Clinical Trials

Course Description

This course is aimed at individuals working in the pharmaceutical industry who will participate in the design and analysis of clinical trial research. The course covers basic concepts of epidemiology and biostatistics as applied to clinical trials, examining research designs, sample size, randomization, and the type of data that must be collected to answer efficacy and no inferiority studies. Through a literature driven approach, students will learn how to analyze results to answer meaningful questions about drugs or devices. The concepts of confidence intervals, p-values, and various statistical tests will be covered. The information gleamed from this course will aid the student in understanding the medical literature and to perform a high level critique of the methods and biostatistics used. Additionally, the students will become familiar with how to report trial results for medical journals.

Credits/Modes of Instruction

Credits: 3

This course is 3-credits and runs 10 weeks, with each week beginning on a Sunday and ending on the following Saturday. This course is a graduate course provided via the internet using the Canvas Platform. Modes of instruction and course format include assigned readings, links to relevant sites on the internet, narrated PowerPoint slideshows (streaming audio or MP3 files), and directed discussion activities, written assignments and real-time video web conferencing meetings to review class materials. All session assignments, PDF formatted handouts, web-conference sessions, video links, podcasts, hyperlinks, readings and other information will be available at the course website or through the University Library Resources website.

Prerequisites

BPHE 5310 Clinical Trials Overview: Methods and Practice.

Course Goals and Outcomes:

Goals

To teach clinical research professionals to interpret the multiple analyses that comprise today’s clinical drug and device research protocols. The two disciplines of epidemiology and biostatistics are brought together since determining drug efficacy as well as causation of adverse drug events necessitates borrowing the perspective and tools from each field. Emphasis is placed on a non-mathematical discussion of the problems faced in interpreting clinical drug trial data.

Outcomes

Discuss the basic principles and applications of epidemiology and biostatistics; Describe major epidemiological study designs including: clinical trials, cohort, case-control, and cross-sectional studies; and their advantages and limitations; Describe statistical approaches for various data types; Interpret and analyze some commonly used descriptive and inferential biostatistics seen in clinical trials; Develop effective methods of data analysis and interpretation pertinent to biomedical research; Review, critique, and evaluate drug related literature; Explain principles of Evidence Based Literature Review.