Statistical Design: Clinical Development of Drugs and Biologics

A few years ago, my colleague Steven E. Linberg was teaching a course, “Clinical Development of Drugs and Biologics,” at Johns Hopkins University. He asked me to give a guest lecture on statistical design.

The class was once per week, 3 hours, in the evening, so I had plenty of time to explain the topic to the students, who were a group with credentials in drug, device, and biologics development, but who mostly knew little about statistics and certainly not much about the practicalities of applying it in real-world research. So I tried to leave them with an emergency first-aid kit that couldn’t really let them do statistical design on their own, but would help them interact with people who could and to ask the right questions.

To add realism, I used the field of spinal cord injury as an extended example of the way that reality can mess up one’s neat assumptions, managerial goals, and mathematical formulas.

So people more interested spinal cord injury than in drug and biologic development may want to read it too.

You can download a pdf version of my slides. It’s relatively long: about 1.3 MB, with 104 slides.

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2 Responses to Statistical Design: Clinical Development of Drugs and Biologics

  1. Gek says:

    Hi, I am interested in your slides but the link seems to be broken, and also
    Inferential Statistics, Descriptive Statistics and The Analysis Plan pdf.

    Thank you,

    • I’m not sure what went wrong. I’ve checked a few times this evening, and both links seem to be working. Perhaps they weren’t when you tried; sometimes my ISP is a little irregular. Please try again. Also remember to be patient while the relatively long PDF files download.

      Thank you for your interest in my writing.

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