Clinical Trials Overview: Phrases and Phases of a Clinical Trials

Dr. Hilary Vernon leads an informative discussion about the basics of clinical trials.

[HeyYall]

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

[Dae]

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

[marypaez]

Very helpful to understand the clinical trial process

[ArashPadidarMD]

Clear and concise informative overview.

[thomaspc]

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

[briceobiang-obounou]

Thanks a lot. this was a great overview

[krishnathyagarajan]

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 ?

[airkuna]

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

[antuoinadams]

Bb8 in the room sometimes it be for people to room

[ahmedabuali]

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 <- array(0, c(2, 3, 2)) # order: tox, eff, immuno
Uti[, , 1] <- matrix(c(0, 0, 50, 10, 80, 35), nrow=2)
Uti[, , 2] <- matrix(c(5, 0, 70, 20, 100, 45), nrow=2)

N.max= 60 # patients

outcomes <- '1NNN 2NNT 3NNT 4NNN 5NTN'
doses = c(.1, .3, .5, .7, .9)


fit <- stan_efftox(outcomes,
real_doses =doses,
efficacy_hurdle = 0.5, toxicity_hurdle = 0.3,
p_e = 0.1, p_t = 0.1,
eff0 = 0.5, tox1 = 0.65,
eff_star = 0.7, tox_star = 0.25,
alpha_mean = -7.9593, alpha_sd = 3.5487,
beta_mean = 1.5482, beta_sd = 3.5018,
gamma_mean = 0.7367, gamma_sd = 2.5423,
zeta_mean = 3.4181, zeta_sd = 2.4406,
eta_mean = 0, eta_sd = 0.2,
psi_mean = 0, psi_sd = 1,
seed = 123)

ndoses <- length(fit$prob_tox)
plot(1:ndoses, fit$prob_tox, type="b", pch=19, xlab="Dose level", ylab="Probability of toxicity", ylim=c(0, max(fit$prob_tox) + 0.15), col="green")
points(1:ndoses, fit$prob_eff, type="b", pch=18, col="blue")
abline(h=0.3, lwd=2, lty=4, col = "red")
legend(1, 0.4, legend=c("Toxicity", "Effecacy"),
col=c("green", "blue"), lty=1:2, cex=0.8)


this produce this figure

could you help me even by the paid consultancy?

Thanks in advance

[samphonnetgamgee]

What is the difference between phase 2 and 3 though ?

[NewmanWilliam-gi]

Brown Timothy Jones Michelle Johnson Joseph