Clinical Trials Overview: Phrases and Phases of a Clinical Trials

[@HeyYall398]

This is very detailed, thorough and informative. Thank you.

[@Dae143]

This was a great overview. Thanks for making this available online !

[@thomaspc1646]

Is there any free certification bodies or institution for clinical trials course

[@krishnathyagarajan9174]

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 ?

[@luvkashyap]

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

[@akshayswami5770]

@@luvkashyap ok

[@harryshi2952]

Thanks for the overview .

[@ArashPadidarMD]

Clear and concise informative overview.

[@marypaez4594]

Very helpful to understand the clinical trial process

[@briceobiang-obounou3794]

Thanks a lot. this was a great overview

[@antuoinadams3358]

I need know about the opiate

[@akellonight8813]

Wonderful presentation

[@kayodeolowomeye6688]

Great Video, Great for CRA'S

[@airkuna]

hi guys. has anybody been already in such clinical trial? have you had any serious or permanent side effect??

[@samphonnetgamgee5625]

What is the difference between phase 2 and 3 though ?

[@Psychoh90]

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.

[@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

[@jannettealicea3313]

Thank you

[@antuoinadams3358]

Bb8 in the room sometimes it be for people to room

[@pawarrajanchandrakant602]

Nice

[@MrGleizicampos]

Very good

[@NewmanWilliam-g9i]

Brown Timothy Jones Michelle Johnson Joseph

[@tammyot]

Spying 🕵️‍♀️