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#276 crpr: describe handling of CR, PR in RECIST vignettes
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bundfussr committed Jan 10, 2025
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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
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7 changes: 7 additions & 0 deletions vignettes/adrs.Rmd
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Expand Up @@ -30,6 +30,13 @@ implementing other response criteria than RECIST 1.1, e.g., iRECIST or
International Myeloma Working Group (IMWG) criteria for the diagnosis of
multiple myeloma.

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.

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
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14 changes: 11 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`.

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`.

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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