Practical Skills in Protocol Writing and Statistical Analytic Programming Relevant to Pharmacoepidemiology

Course Aim
RWE studies evaluating treatment effectiveness or safety involve the analysis of real-world data (RWD) data sources (e.g., claims, EHR data) and have complex and unique characteristics that must be taken into consideration during their planning and conduct. This highly interactive course will engage participants in the following topics:
1. Pre-specifying study components of a 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.

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

Course Objectives
· To introduce a framework for translating study questions into a clear and detailed protocol supported by a rational thought process that is tailored to RWE studies analyzing RWD
· To develop skills in health care data manipulation to support the conduct of a statistical analysis
· To translate a RWE study protocol into a statistical analytic program.

Syllabus Outline
The first part of the class will start with the presentation of an example protocol for a hypothetical case. Using this example, we will walk through a study protocol with substantial inadequacies. A short lecture will follow to address how to write a clear and detailed protocol. Students will form groups to discuss and present their suggestions and approaches to improve the protocol example. The second part of the course includes hands-on session for programing using the previously discussed example protocol.