Closes #234 Add new ADRS vignette

DESCRIPTION

@@ -1,7 +1,7 @@
 Package: admiralonco
 Type: Package
 Title: Oncology Extension Package for ADaM in 'R' Asset Library
-Version: 0.4.0
+Version: 0.5.0
 Authors@R: c(
     person("Stefan", "Bundfuss", email = "[email protected]", role = c("aut", "cre")),
     person("Ross", "Farrugia", role = "aut"),
@@ -53,6 +53,7 @@ Imports:
     rlang (>= 0.4.4),
     tidyselect (>= 1.0.0)
 Suggests:
+    pharmaversesdtm,
     admiral.test,
     devtools,
     diffdf,

NAMESPACE

@@ -1,7 +1,18 @@
 # Generated by roxygen2: do not edit by hand
 
 export(aval_resp)
+export(bor_cr)
+export(bor_ne)
+export(bor_non_crpd)
+export(bor_pd)
+export(bor_pr)
+export(bor_sd)
 export(call_aval_fun)
+export(cb_y)
+export(cbor_cr)
+export(cbor_pr)
+export(crsp_y_cr)
+export(crsp_y_pr)
 export(death_event)
 export(derive_param_bor)
 export(derive_param_clinbenefit)
@@ -12,15 +23,20 @@ export(filter_pd)
 export(get_crpr_dataset)
 export(lasta_censor)
 export(lastalive_censor)
+export(no_data_missing)
+export(no_data_n)
 export(pd_event)
 export(rand_censor)
+export(rsp_y)
 export(signal_crpr)
 export(trts_censor)
 importFrom(admiral,censor_source)
 importFrom(admiral,count_vals)
 importFrom(admiral,derive_extreme_records)
 importFrom(admiral,derive_var_obs_number)
 importFrom(admiral,derive_vars_merged)
+importFrom(admiral,event)
+importFrom(admiral,event_joined)
 importFrom(admiral,event_source)
 importFrom(admiral,filter_extreme)
 importFrom(admiral,filter_joined)

NEWS.md

@@ -1,3 +1,22 @@
+# admiralonco 0.5.0
+
+## New Features
+
+- Oncology specific events are provided for deriving oncology parameters with
+`admiral::derive_extreme_event()`. (#234)
+
+## Documentation
+
+- The `ADRS` vignette and template were split into two:
+    - A basic version which uses the `{admiralonco}` functions to cover standard
+    RECIST 1.1.
+    - A more flexible version which uses `admiral::derive_extreme_event()`. This
+    should be used if non-standard `ADRS` parameters should be implemented or
+    non-standard response values should be considered. This version can also be
+    used as a starting point for implementing other response criteria than
+    RECIST 1.1, e.g., iRECIST or International Myeloma Working Group (IMWG)
+    criteria for the diagnosis of multiple myeloma.
+
 # admiralonco 0.4.0
 
 ## Documentation

R/admiralonco-package.R

@@ -1,9 +1,10 @@
 #' @keywords internal
 #' @family internal
 #' @importFrom admiral censor_source count_vals derive_extreme_records
-#'   derive_var_obs_number derive_vars_merged event_source filter_joined
-#'   filter_extreme filter_relative get_admiral_option list_tte_source_objects
-#'   max_cond min_cond params restrict_derivation set_admiral_options yn_to_numeric
+#'   derive_var_obs_number derive_vars_merged event event_joined event_source
+#'   filter_joined filter_extreme filter_relative get_admiral_option
+#'   list_tte_source_objects max_cond min_cond params restrict_derivation
+#'   set_admiral_options yn_to_numeric
 #' @importFrom admiraldev assert_character_scalar assert_character_vector
 #'   assert_data_frame assert_filter_cond assert_list_of assert_function
 #'   assert_integer_scalar assert_list_of assert_logical_scalar

R/response_sources.R

@@ -0,0 +1,259 @@
+#' Pre-Defined Event Objects
+#'
+#' These pre-defined `event()` and `event_joined()` objects can be used as input
+#' to `admiral::derive_extreme_event()`.
+#'
+#' @details
+#' To see the definition of the various objects simply print the object in the
+#' R console, e.g. `bor_sd`. For details of how to use these objects
+#' please refer to [admiral::derive_extreme_event()].
+#'
+#' It is assumed that `dataset_name = "ovr"` refers to the dataset of the only
+#' overall response assessments at each visit which should be considered for the
+#' parameter derivations. For example the dataset should include only
+#' post-baseline assessments up to first PD and before start of anti-cancer
+#' therapy.
+#'
+#' @seealso [admiral::derive_extreme_event()], [admiral::event()], [admiral::event_joined()]
+#'
+#' @format NULL
+#'
+#' @export
+#'
+#' @keywords source_specifications
+#'
+#' @rdname event_objects
+#'
+#' @examples
+#' # This shows the definition of all pre-defined `event` objects that ship
+#' # with {admiralonco}
+#' exports <- sort(getNamespaceExports("admiralonco"))
+#' for (obj_name in exports) {
+#'   obj <- getExportedValue("admiralonco", obj_name)
+#'   if (inherits(obj, "event_def")) {
+#'     cat("\n", obj_name, ":\n", sep = "")
+#'     print(obj, indent = 2)
+#'   }
+#' }
+rsp_y <- event(
+  description = "Define CR or PR as (unconfirmed) response",
+  dataset_name = "ovr",
+  condition = AVALC %in% c("CR", "PR"),
+  set_values_to = exprs(AVALC = "Y")
+)
+
+#' @format NULL
+#' @keywords source_specifications
+#' @rdname event_objects
+#' @export
+no_data_n <- event(
+  description = "Define no response for all patients in adsl (should be used as last event)",
+  dataset_name = "adsl",
+  condition = TRUE,
+  set_values_to = exprs(AVALC = "N"),
+  keep_source_vars = exprs(RANDDT)
+)
+
+#' @format NULL
+#' @keywords source_specifications
+#' @rdname event_objects
+#' @export
+cb_y <- event(
+  description = paste(
+    "Define CR, PR, SD, or NON-CR/NON-PD occuring at least 42 days after",
+    "randomization as clinical benefit"
+  ),
+  dataset_name = "ovr",
+  condition = AVALC %in% c("CR", "PR", "SD", "NON-CR/NON-PD") &
+    ADT >= RANDDT + 42,
+  set_values_to = exprs(AVALC = "Y")
+)
+
+#' @format NULL
+#' @keywords source_specifications
+#' @rdname event_objects
+#' @export
+bor_cr <- event(
+  description = "Define complete response (CR) for best overall response (BOR)",
+  dataset_name = "ovr",
+  condition = AVALC == "CR",
+  set_values_to = exprs(AVALC = "CR")
+)
+
+#' @format NULL
+#' @keywords source_specifications
+#' @rdname event_objects
+#' @export
+bor_pr <- event(
+  description = "Define partial response (PR) for best overall response (BOR)",
+  dataset_name = "ovr",
+  condition = AVALC == "PR",
+  set_values_to = exprs(AVALC = "PR")
+)
+
+#' @format NULL
+#' @keywords source_specifications
+#' @rdname event_objects
+#' @export
+bor_sd <- event(
+  description = paste(
+    "Define stable disease (SD) for best overall respone (BOR) as CR, PR, or SD",
+    "occurring at least 42 days after randomization"
+  ),
+  dataset_name = "ovr",
+  condition = AVALC %in% c("CR", "PR", "SD") & ADT >= RANDDT + 42,
+  set_values_to = exprs(AVALC = "SD")
+)
+
+#' @format NULL
+#' @keywords source_specifications
+#' @rdname event_objects
+#' @export
+bor_non_crpd <- event(
+  description = paste(
+    "Define NON-CR/NON-PD for best overall response (BOR) as NON-CR/NON-PD",
+    "occuring at least 42 days after randomization"
+  ),
+  dataset_name = "ovr",
+  condition = AVALC == "NON-CR/NON-PD" & ADT >= RANDDT + 42,
+  set_values_to = exprs(AVALC = "NON-CR/NON-PD")
+)
+
+#' @format NULL
+#' @keywords source_specifications
+#' @rdname event_objects
+#' @export
+bor_pd <- event(
+  description = "Define progressive disease (PD) for best overall response (BOR)",
+  dataset_name = "ovr",
+  condition = AVALC == "PD",
+  set_values_to = exprs(AVALC = "PD")
+)
+
+#' @format NULL
+#' @keywords source_specifications
+#' @rdname event_objects
+#' @export
+bor_ne <- event(
+  description = paste(
+    "Define not evaluable (NE) for best overall response (BOR) as SD, NON-CR/NON-PD,",
+    "or NE (should be specified after bor_sd and bor_non_crpd)"
+  ),
+  dataset_name = "ovr",
+  condition = AVALC %in% c("SD", "NON-CR/NON-PD", "NE"),
+  set_values_to = exprs(AVALC = "NE")
+)
+
+#' @format NULL
+#' @keywords source_specifications
+#' @rdname event_objects
+#' @export
+no_data_missing <- event(
+  description = paste(
+    "Define missing response (MISSING) for all subjects in adsl in your population",
+    "who has no post baseline response (should be used as last event)"
+  ),
+  dataset_name = "adsl",
+  condition = TRUE,
+  set_values_to = exprs(AVALC = "MISSING"),
+  keep_source_vars = exprs(RANDDT)
+)
+
+#' @format NULL
+#' @keywords source_specifications
+#' @rdname event_objects
+#' @export
+crsp_y_cr <- event_joined(
+  description = paste(
+    "Define confirmed response as CR followed by CR at least 28 days later and",
+    "at most one NE in between"
+  ),
+  dataset_name = "ovr",
+  join_vars = exprs(AVALC, ADT),
+  join_type = "after",
+  order = exprs(ADT),
+  first_cond = AVALC.join == "CR" &
+    ADT.join >= ADT + days(28),
+  condition = AVALC == "CR" &
+    all(AVALC.join %in% c("CR", "NE")) &
+    count_vals(var = AVALC.join, val = "NE") <= 1,
+  set_values_to = exprs(AVALC = "Y")
+)
+
+#' @format NULL
+#' @keywords source_specifications
+#' @rdname event_objects
+#' @export
+crsp_y_pr <- event_joined(
+  description = paste(
+    "Define confirmed response as PR followed by CR or PR at least 28 days later,",
+    "at most one NE in between, and no PR after CR"
+  ),
+  dataset_name = "ovr",
+  join_vars = exprs(AVALC, ADT),
+  join_type = "after",
+  order = exprs(ADT),
+  first_cond = AVALC.join %in% c("CR", "PR") &
+    ADT.join >= ADT + days(28),
+  condition = AVALC == "PR" &
+    all(AVALC.join %in% c("CR", "PR", "NE")) &
+    count_vals(var = AVALC.join, val = "NE") <= 1 &
+    (
+      min_cond(
+        var = ADT.join,
+        cond = AVALC.join == "CR"
+      ) > max_cond(var = ADT.join, cond = AVALC.join == "PR") |
+        count_vals(var = AVALC.join, val = "CR") == 0 |
+        count_vals(var = AVALC.join, val = "PR") == 0
+    ),
+  set_values_to = exprs(AVALC = "Y")
+)
+
+#' @format NULL
+#' @keywords source_specifications
+#' @rdname event_objects
+#' @export
+cbor_cr <- event_joined(
+  description = paste(
+    "Define complete response (CR) for confirmed best overall response (CBOR) as",
+    "CR followed by CR at least 28 days later and at most one NE in between"
+  ),
+  dataset_name = "ovr",
+  join_vars = exprs(AVALC, ADT),
+  join_type = "after",
+  first_cond = AVALC.join == "CR" &
+    ADT.join >= ADT + 28,
+  condition = AVALC == "CR" &
+    all(AVALC.join %in% c("CR", "NE")) &
+    count_vals(var = AVALC.join, val = "NE") <= 1,
+  set_values_to = exprs(AVALC = "CR")
+)
+
+#' @format NULL
+#' @keywords source_specifications
+#' @rdname event_objects
+#' @export
+cbor_pr <- event_joined(
+  description = paste(
+    "Define partial response (PR) for confirmed best overall response (CBOR) as",
+    "PR followed by CR or PR at least 28 days later, at most one NE in between,",
+    "and no PR after CR"
+  ),
+  dataset_name = "ovr",
+  join_vars = exprs(AVALC, ADT),
+  join_type = "after",
+  first_cond = AVALC.join %in% c("CR", "PR") &
+    ADT.join >= ADT + 28,
+  condition = AVALC == "PR" &
+    all(AVALC.join %in% c("CR", "PR", "NE")) &
+    count_vals(var = AVALC.join, val = "NE") <= 1 &
+    (
+      min_cond(
+        var = ADT.join,
+        cond = AVALC.join == "CR"
+      ) > max_cond(var = ADT.join, cond = AVALC.join == "PR") |
+        count_vals(var = AVALC.join, val = "CR") == 0 |
+        count_vals(var = AVALC.join, val = "PR") == 0
+    ),
+  set_values_to = exprs(AVALC = "PR")
+)