Designing Clinical Trials

Presented by Dr. Brent Logan, PhD, Professor in the Division of Biostatistics, Medical College of Wisconsin.
This lecture will provide an overview of study designs and statistical issues in all phases of clinical trials. We will start by describing dose-finding phase I designs, and then will cover phase II designs, including the framework for determining sample size and the use of two-stage designs. The remainder of the lecture will focus on major design issues in phase III clinical trials, including endpoint specification, eligibility, power and sample size calculation, blinding, randomization, stratification, and data monitoring.

[@BucurEST1989]

Great presentation Dr.Logan.

[@WCCTGlobal]

Thanks Dr. Logan for this informative overview.

[@ahmedabuali6768]

Dear Professor,
I am trying to implement the work done by Suyu Liu, “A Bayesian Phase I/II Trial Design for Immunotherapy”, using R, since the code attached with that work takes a lot of time (more than 20 hours and the code not complete, I do not know how it produced the tables and the figures).
So that I tried to use trialr package trying to get similar or approximate results using the utility functions for sensitivity analysis in table 1 (picture below), but this package allowed me to use just two outcomes ( toxicity, efficacy ) and the work of Liu used three outcomes (immune response, toxicity, and efficacy). I want to see if I used the correct utility (table 1 below) and to see how to add a third outcome ( immune response ) to the model? (Question 1)
I attached to you the code and the output for 50 iterations and 60 patients from the work of Liu and Yuan ( I cannot do more, it took around 12 hours), if you know how he produced the results, (Question 2) I hope you can feed me back.
My goal is: to use their idea to select the best dose in the first stage and to continue in a second stage with only 2 arms clinical trial and the best dose. (may there is another way to do that?)
Table 1
### My code trying to get similar results using trialr package ###
rm(list = ls())
library(trialr)
## Utility from table 1 and Liu and Yuan work.
Uti

[@IsaacWebers]

Are these slides available for download?

[@tammyot]

Spying 🕵️‍♀️