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2 changes: 1 addition & 1 deletion DESCRIPTION
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Expand Up @@ -3,13 +3,13 @@ Package: phase1b
Title: Calculations for decisions on Phase 1b clinical trials
Version: 1.0.0
Authors@R: c(
person("Audrey", "Yeo", , "[email protected]", role = c("aut")),
person("Daniel", "Sabanes Bove", , "[email protected]", role = c("aut", "cre")),
person("Markus", "Elze", , "[email protected]", role = "aut"),
person("Tony", "Pourmohamad", , "[email protected]", role = "aut"),
person("Jiawen", "Zhu", , "[email protected]", role = "aut"),
person("James", "Lymp", role = "aut"),
person("Anastasia", "Teterina", , "[email protected]", role = "aut"),
person("Audrey", "Yeo", , "[email protected]", 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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57 changes: 29 additions & 28 deletions README.md
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Expand Up @@ -2,34 +2,39 @@

<!-- markdownlint-disable -->

<img src="man/figures/hex_logo3.png" alt="hex logo" style="display: inline-block; width:200px; margin: 0 auto auto auto;" />
<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 project is a 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 (Yeo et al, 2024) 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 expanding current 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.
(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 expanding current 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

Expand All @@ -50,9 +55,5 @@ function in your console to access the documentation.

## Citing `phase1b`

To cite `phase1b` :

Yeo, A T, Sabanés Bové D, Elze M, Pourmohamad T, Zhu J, Lymp J, Teterina
A (2024). Phase1b : Calculations for decisions on Phase 1b clinical
trials. R package version 1.0.0, \<
<https://genentech.github.io/phase1b/>\>
To cite `phase1b` please see
[here](https://genentech.github.io/phase1b/main/authors.html#citation).
18 changes: 10 additions & 8 deletions README.rmd
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Expand Up @@ -4,11 +4,17 @@ output: github_document

# phase1b
<!-- markdownlint-disable -->
<img src="man/figures/hex_logo3.png" alt="hex logo" style="display: inline-block; width:200px; margin: 0 auto auto auto;" />
<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 (Yeo et al, 2024) 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 expanding current 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.
The phase1b package project is a 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 expanding current 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

Expand All @@ -27,8 +33,4 @@ An introductory vignette is currently being prepared. Use the help function in y

## Citing `phase1b`

To cite `phase1b` :

Yeo, A T, Sabanés Bové D, Elze M, Pourmohamad T, Zhu J, Lymp J, Teterina A (2024).
Phase1b : Calculations for decisions on Phase 1b clinical trials. R package
version 1.0.0, < https://genentech.github.io/phase1b/>
To cite `phase1b` please see [here](https://genentech.github.io/phase1b/main/authors.html#citation).
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al
analysed
apriori
AQAAQBAJ
bA
ba
BayesBetaBinom
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2 changes: 1 addition & 1 deletion man/Phase1b-package.Rd

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121 changes: 121 additions & 0 deletions man/ocPredprob.Rd

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