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Academic Catalog 2022-2023

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  • Real-World Evidence in Healthcare and Life Sciences, MS

Real-World Evidence in Healthcare and Life Sciences, MS

2022-2023 Edition

  • Undergraduate
  • College of Professional Studies Undergraduate
  • Graduate
    • General Admission and Transfer Credit
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    • Bouvé College of Health Sciences
      • Academic Policies and Procedures
      • Interdisciplinary
      • School of Clinical and Rehabilitation Sciences
      • School of Community Health and Behavioral Sciences
        • Counseling Psychology, PhD
        • School Psychology, PhD
        • Applied Behavior Analysis, CAGS
        • Counseling Psychology, CAGS
        • School Psychology, CAGS
        • Applied Behavior Analysis, MS
        • Applied Educational Psychology, MS
        • Applied Psychology, MS
        • Counseling Psychology, MSCP
        • Applied Behavior Analysis, Graduate Certificate
        • Personal Health Informatics, PhD
        • Population Health, PhD
        • Public Health, MPH
        • Exercise Science, MS—Online
        • Exercise Science with Concentration in Physical Activity and Public Health, MS
        • Health Informatics, MS
        • Real-​World Evidence in Healthcare and Life Sciences, MS
        • Law, JD /​ Public Health, MPH
        • Pharmacy, PharmD—Direct Entry /​ Public Health, MPH
        • Physician Assistant Studies, MS /​ Public Health, MPH
        • Public Health, MPH /​ Exercise Science with Concentration in Physical Activity, MS
        • Public Health, MPH /​ Health Informatics, MS
        • Exercise Science for Clinicians, Graduate Certificate
      • School of Nursing
      • School of Pharmacy and Pharmaceutical Sciences
    • School of Law
    • College of Professional Studies
    • College of Science
    • College of Social Sciences and Humanities
    • Gordon Institute of Engineering Leadership
    • Additional Programs
    • Faculty
    • Appendix
  • Course Descriptions
  • Catalog Archives
  • Overview
  • Program Requirements

The Master of Science in Real-World Evidence (RWE) is an interdisciplinary, flexible, and contemporary degree that focuses on best practices for the appropriate acquisition and analysis of observational health data. Housed in the Department of Health Sciences and the Roux Institute, learners explore how observational research produces a comprehensive understanding of disease, including experience with appropriate methods and software to conduct this research.  

RWE is the clinical evidence regarding the usage and potential benefits, or risks, of a medical product derived from analysis of real-world data (RWD). RWE can be generated by different study designs or analyses, including but not limited to randomized trials, pragmatic trials, and observational studies. RWD are the data relating to patient health status and/or the delivery of healthcare routinely collected from a variety of sources, for example, electronic health records, claims, and billing activities. 

RWD and RWE are playing an increasing role in healthcare decisions. The FDA uses RWD and RWE to monitor postmarket safety and to make regulatory decisions. The healthcare community uses these data to support coverage decisions and to develop guidelines and decision support tools for clinical practice. Medical product developers use RWD and RWE to support clinical trial designs and observational studies to generate innovative, new treatment approaches. 

This program is based on open, reproducible science—including the use of common data models and open-source analytics software to codify these practices into consistent, transparent, reproducible solutions—and applies these tools and practices to answer clinical questions by generating evidence to guide healthcare policy and improve patient outcomes. 

The program seeks to educate two key professionals: analysts and researchers. 

An analyst is a technician (e.g., solution architect, epidemiologist, data scientist, etc.) who is engaging in RWE studies by utilizing statistical tools and epidemiologic methods to operationalize and analyze RWD. Technicians may be carrying out activities on behalf of an institution or may be working as individuals interested in the technology that RWD offers. They may be involved in any stage of the RWD/RWE continuum (extract-transform-load [ETL]/data quality processes, tool enablement and self-service analytics, visualization, communication) and are often interested in extending these resources to serve additional use cases or new functionality. 

A researcher is one who originates from any number of backgrounds (statistics, clinical training, public health, biological sciences, data science, etc.) who engages in the RWD community for the sake of designing and conducting a research study. Researchers want to know how to run their own observational research studies. In their day, researchers were often responsible for translating the science into better decisions and better care.

The intent of this program is to curate interdisciplinary expertise to support the evidence-generation process in the pharmacoepidemiology research community. The curriculum aims to ensure that learners can obtain in-demand skills that are immediately deployable in roles at pharmaceutical companies, regulatory authorities, health systems, technology companies, and consulting groups specializing in life sciences and healthcare.

Please visit Bouvé College Learning Outcomes for the specific student learning outcomes for this program.

Complete all courses and requirements listed below unless otherwise indicated.

Core Requirements

A grade of B– or higher is required in each course.

Course List
Code Title Hours
HSCI 5130Introduction to Real-World Evidence2
HSCI 5140Foundations of Data Models2
HSCI 5150Methods for Observational Research 13
HSCI 5151Methods for Observational Research 23
HSCI 5160Standardization of Real-World Data2
HSCI 5170Data Model Transformation2
PHSC 5212Research Skills and Ethics2
Capstone Requirement
HSCI 6980Real-World Evidence Capstone3

Selectives 

Course List
Code Title Hours
Complete a minimum of 6 semester hours from the following:6-12
HSCI 5180
Phenotyping
HSCI 5190
Cohort Building
HSCI 6110
Advanced Population Characterization
HSCI 6120
Advanced Population Estimation
HSCI 6130
Advanced Patient Prediction

Electives

Course List
Code Title Hours
Complete up to 6 semester hours from the following (electives are selected in consultation with the program director):6
HINF 5300
Personal Health Interface Design and Development
HINF 6205
Creation and Application of Medical Knowledge
HINF 6220
Database Design, Access, Modeling, and Security
HINF 6355
Interoperability Key Standards in Health Informatics

Program Credit/GPA Requirements

31 total semester hours required

Minimum 3.000 GPA required

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