Thanks for a very detailed explanation especially for folks with no background. Q1: for covid what phases were bypassed to expedite the process ? Q2: Are IRB members staff of FDA ? Q3: who funds them ? The Sponsor ?
Q1: for covid what phases were bypassed to expedite the process ? = Depends on case by case. This is not applicable for all engaged in Covid. For example, Moderna was given that choice but others were not (Inovio Pharma) Q2: Are IRB members staff of the FDA ? Yes, its independent body specifically for all Ethical adherence Q3: who funds them ? The Sponsor ? Yes Sponsors
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
