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Co-authored-by: 27856297+dependabot-preview[bot]@users.noreply.github.com <27856297+dependabot-preview[bot]@users.noreply.github.com>
Co-authored-by: Daniel Sabanes Bove <danielinteractive@users.noreply.github.com>
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3 changes: 2 additions & 1 deletion DESCRIPTION
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Expand Up @@ -3,12 +3,13 @@ Package: phase1b
Title: Calculations for decisions on Phase 1b clinical trials
Version: 1.0.0
Authors@R: c(
person("Daniel", "Sabanes Bove", , "daniel.sabanes_bove@roche.com", role = c("aut", "cre")),
person("Daniel", "Sabanes Bove", , "daniel@rconis.com", role = c("aut", "cre")),
person("Markus", "Elze", , "markus.elze@roche.com", role = "aut"),
person("Tony", "Pourmohamad", , "pourmoht@gene.com", role = "aut"),
person("Jiawen", "Zhu", , "zhu.jiawen@gene.com", role = "aut"),
person("James", "Lymp", role = "aut"),
person("Anastasia", "Teterina", , "anastasia.teterina@roche.com", role = "aut"),
person("Audrey", "Yeo", , "audrey.yeo@roche.com", role = c("aut")),
person("F. Hoffmann-La Roche Ltd", role = c("cph", "fnd"))
)
Description: The phase1b R package is intended to be used when conducting
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4 changes: 2 additions & 2 deletions R/plotBeta.R
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Expand Up @@ -2,19 +2,19 @@
#'
#' This function will plot the PDF of a beta distribution
#'
#' @inheritParams dbetabinom
#' @typed alpha : number
#' first parameter of the Beta distribution
#' @typed beta : number
#' second parameter of the Beta distribution
#'
#' @return A beta distribution density plot
#'
#' @importFrom graphics axis
#'
#' @example examples/plotBeta.R
#' @export
#' @keywords graphics
plotBeta <- function(alpha, beta, ...) {
plotBeta <- function(alpha, beta) {
x_support <- seq(from = 0, to = 1, length = 1000)
data <- data.frame(
grid = x_support,
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60 changes: 58 additions & 2 deletions README.md
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@@ -1,3 +1,59 @@
# phase1b
# `phase1b`

Short description of the package
<!-- markdownlint-disable -->

<img src="man/figures/hex_logo3.png" align = "right" alt="hex logo" style="display: inline-block; width:200px; margin: 0 auto auto auto;" />
<!-- markdownlint-enable -->

The `phase1b` package implements a Bayesian approach to decision making
in early development clinical trials. As a background, the main purpose
of early trials is to determine whether a novel treatment demonstrates
sufficient safety and efficacy signals to warrant further investment
(Lee & Liu, 2008).

The new R package `phase1b` is a flexible toolkit that calculates many
properties to this end, especially in the oncology therapeutic area. The
primary focus of this package is on binary endpoints. The benefit of a
Bayesian approach is the possibility to account for prior data (Thall &
Simon, 1994) in that a new drug may have shown some signals of efficacy
owing to its proposed mode of action, or similar activity based on prior
data. The concept of the `phase1b` package is to evaluate the posterior
probability that the response rate with a novel drug is better than with
the current standard of care treatment in early phase trials such as
Phase I.

The `phase1b` package provides a facility for early development study
teams to decide on further development of a drug either through
designing for phase 2 or 3, or expansion cohorts. The prior distribution
can incorporate any previous data via mixtures of beta distributions.
Furthermore, based on an assumed true response rate if the novel drug
was administered in the wider population, the package calculates the
frequentist probability that a current clinical trial would be stopped
for efficacy or futility conditional on true values of the response,
otherwise known as operating characteristics.

The intended user is the early clinical trial statistician in the design
and interim stage of their study and offers a flexible approach to
setting priors and weighting.

## Installation

### Development

You can install the development version of `phase1b` from
[GitHub](https://github.com/) with:

```r
devtools::install_github("https://github.com/Genentech/phase1b/", force = TRUE)
library(phase1b)
```

## Getting Started

An introductory vignette is currently being prepared. Use the help
function in your console to access the documentation.

## Citing `phase1b`

To cite `phase1b` please see
[here](https://genentech.github.io/phase1b/main/authors.html#citation).
36 changes: 36 additions & 0 deletions README.rmd
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@@ -0,0 +1,36 @@
---
output: github_document
---

# `phase1b`
<!-- markdownlint-disable -->
<img src="man/figures/hex_logo3.png" align = "right" alt="hex logo" style="display: inline-block; width:200px; margin: 0 auto auto auto;" />
<!-- markdownlint-enable -->

The `phase1b` package implements a Bayesian approach to decision making in early development clinical trials.
As a background, the main purpose of early trials is to determine whether a novel treatment demonstrates sufficient safety and efficacy signals to warrant further investment (Lee & Liu, 2008).

The new R package `phase1b` is a flexible toolkit that calculates many properties to this end, especially in the oncology therapeutic area. The primary focus of this package is on binary endpoints. The benefit of a Bayesian approach is the possibility to account for prior data (Thall & Simon, 1994) in that a new drug may have shown some signals of efficacy owing to its proposed mode of action, or similar activity based on prior data. The concept of the `phase1b` package is to evaluate the posterior probability that the response rate with a novel drug is better than with the current standard of care treatment in early phase trials such as Phase I.

The `phase1b` package provides a facility for early development study teams to decide on further development of a drug either through designing for phase 2 or 3, or expansion cohorts. The prior distribution can incorporate any previous data via mixtures of beta distributions. Furthermore, based on an assumed true response rate if the novel drug was administered in the wider population, the package calculates the frequentist probability that a current clinical trial would be stopped for efficacy or futility conditional on true values of the response, otherwise known as operating characteristics.

The intended user is the early clinical trial statistician in the design and interim stage of their study and offers a flexible approach to setting priors and weighting.

## Installation

### Development

You can install the development version of `phase1b` from [GitHub](https://github.com/) with:

``` r
devtools::install_github("https://github.com/Genentech/phase1b/", force = TRUE)
library(phase1b)
```

## Getting Started

An introductory vignette is currently being prepared. Use the help function in your console to access the documentation.

## Citing `phase1b`

To cite `phase1b` please see [here](https://genentech.github.io/phase1b/main/authors.html#citation).
2 changes: 1 addition & 1 deletion inst/REFERENCES.bib
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Expand Up @@ -3,7 +3,7 @@ @book{held-sabanes-2015
author={Held, Leonhard and {Saban\'es Bov\'e}, Daniel},
publisher={Springer},
year={2015},
url={http://www.springer.com/us/book/9783642378867}
url={https://link.springer.com/book/10.1007/978-3-642-37887-4}
}

@book{berry:2011,
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28 changes: 26 additions & 2 deletions inst/WORDLIST
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@@ -1,3 +1,4 @@
al
analysed
apriori
bA
Expand All @@ -23,6 +24,7 @@ bI
Binom
binom
Biometrics
Biostatistics
bL
bLambda
blambda
Expand All @@ -31,15 +33,16 @@ bmu
boldsymbol
bOmega
bomega
Bov<U+00E9>
Bove
Bové
bPhi
bphi
bpi
bPsi
bpsi
bR
br
Branson
bS
bs
bsig
Expand All @@ -63,6 +66,7 @@ comparator
conjugacy
Cov
cov
CRC
cutB
cutW
dec
Expand All @@ -77,6 +81,7 @@ diffience
doi
DoR
dP
Dunson
dW
dw
dX
Expand All @@ -86,37 +91,48 @@ ee
Elze
eq
estunated
et
EVAL
ExpectedN
ExpectedNactive
ExpectedNcontrol
frac
funder
gelman
Gelman
generalizable
geq
grayzone
grey
Gsponer
hier
Hoffmann
http
https
hyoithesis
hyperprior
increasement
inefficacious
infty
Integrand
integrations
isbn
Jiawen
kernal
lccn
LciU
ldots
Leonhard
leq
Liu
ller
Lymp
Markus
mathbb
mathbf
mathcal
mbox
Neuenschwander
newcommand
Nmax
NmaxControl
Expand All @@ -136,6 +152,7 @@ ocPredprob
ocPredprobDist
ocRctPostprobDist
ocRctPredprobDist
onlinelibrary
params
parX
parY
Expand Down Expand Up @@ -184,8 +201,9 @@ renewcommand
reproducibility
responder
responders
Saban<U+00E9>s
Sabanes
sabanes
Sabanés
SampleSize
SampleSizeActive
SampleSizeControl
Expand All @@ -195,6 +213,8 @@ simplifiedWeightedBayes
simplifiedWeightedBayesone
simplifiedWeightedBayestwo
specialised
springer
Springer
sumbetadiff
summerize
summerizes
Expand Down Expand Up @@ -223,10 +243,14 @@ USUBJID
VAD
vanillaBayes
vanillaPP
Vehtari
WeightedBayes
weightedBetaPrior
wiley
xL
xS
xU
XYZ
Yeo
Zhu
ZXL
3 changes: 2 additions & 1 deletion man/Phase1b-package.Rd

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2 changes: 1 addition & 1 deletion man/plotBeta.Rd

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9 changes: 4 additions & 5 deletions vignettes/introduction.Rmd
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Expand Up @@ -10,7 +10,7 @@ author:
- name: Jiawen Zhu
email: zhu.jiawen@gene.com
- name: Daniel Sabanes Bove
email: daniel.sabanes_bove@roche.com
email: daniel@rconis.com
output:
bookdown::html_document2:
theme: "spacelab"
Expand Down Expand Up @@ -166,8 +166,7 @@ help(package = "phase1b")

A list of functions will be displayed and you can learn more about each function,
and see examples of its use, by clicking on its corresponding link.
Note that this will easiest work in R-Studio
((https://www.rstudio.com/products/rstudio/download/)), which
Note that this will easiest work in [R-Studio](https://posit.co/download/rstudio-desktop/), which
is the recommended software for editing and using R.

# Methods and Models {#methods}
Expand Down Expand Up @@ -665,12 +664,12 @@ ex1_prior_myplot_cap <- paste(
```

```{r ex1_prior_plotBeta, echo=TRUE, fig.cap = ex1_prior_myplot_cap}
plotBeta(alpha = 75, beta = 75, col = "darkgrey", ylim = c(0, 10), xlab = "PET-CR Rate", lwd = 2)
plotBeta(alpha = 75, beta = 75)
```

For the Novel combination, the following posterior has been updated.
```{r ex1_prior_plotBeta2, fig.cap = ex1_prior_myplot_cap}
plotBeta(5.75, 4.25, col = "deepskyblue", ylim = c(0, 10), lwd = 2, xlab = "")
plotBeta(alpha = 5.75, beta = 4.25)
```


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