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Merge pull request #298 from pharmaverse/276_crpr
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Closes #276 crpr: describe handling of CR, PR in RECIST vignettes
bundfussr authored Jan 24, 2025
2 parents c37d304 + 9e4bfb9 commit cb48eb2
Showing 3 changed files with 30 additions and 3 deletions.
8 changes: 8 additions & 0 deletions NEWS.md
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# admiralonco (development version)

## Documentation

- The vignettes "Creating a Basic ADRS" and "Creating ADRS (Including
Non-standard Endpoints)" were updated to describe how the case `CR` followed by
`PR` is handled. (#276)

# admiralonco 1.1.0

## Documentation
9 changes: 9 additions & 0 deletions vignettes/adrs.Rmd
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International Myeloma Working Group (IMWG) criteria for the diagnosis of
multiple myeloma.

For confirmation of response particularly, `CR`, the case that `CR` is followed
by `PR` (or `SD`) is considered as a data issue and the derivations of the
parameters don't handle this case specially. It is recommended to fix the issue
in the source data, e.g., by changing the `PR` to `PD` rather than handling it
in the parameter derivations. This ensures consistency across parameters.
However, `admiral::derive_extreme_event()` is so flexible that it is possible to
handle it in the parameter derivations, for example, by redefining the `bor_pr`
event and adding an additional `PD` event.

Examples are currently presented and tested using `ADSL` (ADaM) and
`RS`, `TU` (SDTM) inputs. However, other domains could be used. The
functions and workflow could similarly be used to create an intermediary
16 changes: 13 additions & 3 deletions vignettes/adrs_basic.Rmd
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# Introduction

This article describes creating an `ADRS` ADaM with common oncology
endpoint parameters based on RECIST v1.1. Therefore response values are
expected as either `CR`, `PR`, `SD`, `NON-CR/NON-PD`, `PD` or `NE`.
This article describes creating an `ADRS` ADaM with common oncology endpoint
parameters based on RECIST v1.1. Therefore response values are expected as
either `CR`, `PR`, `SD`, `NON-CR/NON-PD`, `PD` or `NE`.

For confirmation of response particularly, `CR`, the case that `CR` is followed
by `PR` (or `SD`) is considered as a data issue and the derivations of the
parameters don't handle this case specially. The `{admiralonco}` functions don't
provide functionality to handle this case. It is recommended to fix the issue in
the source data, e.g., by changing the `PR` to `PD` rather than handling it in
the parameter derivations. This ensures consistency across parameters. The
functions `derive_param_confirmed_bor()` and `derive_param_confirmed_resp()`
issue a warning if `CR` is followed by `PR` (the warning does not display if
`CR` is followed by `SD`).

Please note that this vignette describes the endpoints which were considered by
the admiralonco team as the most common ones. The admiralonco functions used to

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