Trial concept calculated: type of internal control. ICH E10 lists as types of control: placebo concurrent control, no-treatment concurrent control, dose-response concurrent control, active (positive) concurrent control, external (including historical) control, multiple control groups. Dose-controlled trials are currently not identified. External (including historical) controls are so far not identified in specific register fields. Cross-over designs, where identifiable, have active controls.
Arguments
- df
data frame such as from dbGetFieldsIntoDf. If `NULL`, prints fields needed in `df` for calculating this trial concept, which can be used with dbGetFieldsIntoDf.
Value
data frame with columns `_id` and `.controlType`, which is a factor with levels `none`, `no-treatment`, `placebo`, `active`, `placebo+active` and `other`.
Examples
# fields needed
f.controlType()
#> $euctr
#> [1] "e81_controlled"
#> [2] "e816_cross_over"
#> [3] "e817_other"
#> [4] "e8171_other_trial_design_description"
#> [5] "e822_placebo"
#> [6] "e823_other"
#> [7] "e8231_comparator_description"
#> [8] "e824_number_of_treatment_arms_in_the_trial"
#>
#> $ctgov
#> [1] "arm_group.arm_group_type"
#>
#> $ctgov2
#> [1] "protocolSection.designModule.designInfo.interventionModel"
#> [2] "protocolSection.armsInterventionsModule.armGroups.type"
#>
#> $isrctn
#> [1] "trialDesign.studyDesign" "trialDesign.primaryStudyDesign"
#>
#> $ctis
#> [1] "authorizedPartI.productRoleGroupInfos.productRoleName"
#> [2] "authorizedApplication.authorizedPartI.productRoleGroupInfos.productRoleName"
#>
if (FALSE) { # \dontrun{
# apply trial concept when creating data frame
dbc <- nodbi::src_sqlite(
dbname = system.file("extdata", "demo.sqlite", package = "ctrdata"),
collection = "my_trials", flags = RSQLite::SQLITE_RO)
trialsDf <- dbGetFieldsIntoDf(
calculate = "f.controlType",
con = dbc)
} # }