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
This is very detailed, thorough and informative. Thank you.
Is there any free certification bodies or institution for clinical trials course
Brown Timothy Jones Michelle Johnson Joseph
Hernandez Maria Garcia Angela Robinson Sharon
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
@@luvkashyap ok
Thank you
Thanks a lot. this was a great overview
This was a great overview. Thanks for making this available online !
Great Video, Great for CRA'S
Thanks for the overview .
hi guys. has anybody been already in such clinical trial? have you had any serious or permanent side effect??
Bb8 in the room sometimes it be for people to room
I need know about the opiate
Clear and concise informative overview.
Wonderful presentation
Very helpful to understand the clinical trial process
Spying 🕵️♀️
What is the difference between phase 2 and 3 though ?
Phase 3 it is always randomised. There are from hundreds to thousands of patients under investigation, compared to the 100 to 500 patients in phase 2.
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
Nice
Very good