Skip to main content
2025 ISPE Annual Meeting Main banner

SC-12 - Practical Skills in Protocol Writing and Statistical Analytic Programming Relevant to Studies Generating Real-World Evidence

Friday, August 22, 2025
2:30 PM - 6:00 PM ET
Location: Ballroom AB
1. Course Aim
RWE studies evaluating treatment effectiveness or safety involve the analysis of real-world data (RWD) data sources (e.g. claims, EMRs) and have complex and unique characteristics that must be taken into consideration during study planning and conduct. This highly interactive course will engage participants in the following topics:
1. Pre-specifying components of a RWE study protocol, including design, analysis, and reporting of the study, along with a science-based rationale for the choices pertaining to these components; and
2. Translating elements of the study protocol into a statistical analytic program.

2. Requisites Statement
Intermediate level course. An understanding of basic statistical programming language is required.
Prior attendance of the “Introduction to Pharmacoepidemiology” class is encouraged, although not required. The course content is complementary to the “Introduction to Pharmacoepidemiology” class.

3. Course Objectives

• To introduce a framework for translating study questions into a clear and detailed protocol that is tailored to RWE studies and that supports transparency and reproducibility
• To translate a RWE study protocol into a statistical analytic program
• To develop skills in the analysis of RWD.

4. Syllabus Outline

The first part of the class will start with the presentation of an example protocol for a hypothetical RWE case study. A lecture will follow that will address how to write and what to specify in each section of a protocol. Throughout the lecture, the instructors will use the case study to illustrate inadequacies in the protocol. After the lecture, students will be divided up into groups to discuss and present their suggestions for improving the protocol. The second part of the course will include a demonstration of the operationalization of the RWE case study protocol and will include a hands-on programing session using the RWE case study protocol.