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What can you use to find out the similarities and differences between medical products? The answer is statistic or more specifically biostatistics.

This course will provide you with a broad understanding and guidance documents of the application of biostatistics in a regulatory context. The topics include are basic study design, target population, comparison groups, and endpoints. You will be able to addresses analysis issues including issues of missing data and informative censoring.


This course does not involve any written exams. Students need to answer 5 assignment questions to complete the course, the answers will be in the form of written work in pdf or word. Students can write the answers in their own time. Each answer needs to be 200 words (1 Page). Once the answers are submitted, the tutor will check and assess the work.


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Course Credit: JHSPH Open

Course Curriculum

Lecture 1 Biostatistics in Medical Product Regulation Introduction ( Day ) 00:15:00
Lecture 2 Study Designs, Objectives, Hypotheses (Foulkes) 00:20:00
Lecture 3 Study Populations (Day) 00:10:00
Lecture 4 Study Designs (Day) 00:35:00
Lecture 5 Comparison Control Groups (Foulkes) 00:20:00
Lecture 6 Outcomes, Surrogates, Composite Endpoints (Day) 00:30:00
Lecture 7 Analysis Issues, ITT, Post-Hoc, and Subgroups (Day) 00:25:00
Lecture 8 Multiplicity, Missing Data (Foulkes) 00:25:00
Lecture 9 Non-Inferiority Specification of Delta (Foulkes) 00:20:00
Lecture 10 Multi-Regional Studies and Bridging Studies (Day) 00:15:00
Lecture 11 Interim Monitoring (Foulkes) 00:30:00
Lecture 12 Course Summary and Review (Foulkes) 00:15:00
Submit Your Assignment 00:00:00
Certification 00:00:00

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