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 indffor 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] "e822_placebo"
#> [4] "e823_other"
#> [5] "e8231_comparator_description"
#> [6] "e824_number_of_treatment_arms_in_the_trial"
#> [7] "subjectDisposition.postAssignmentPeriods.postAssignmentPeriod.arms.arm.type.value"
#>
#> $ctgov
#> [1] "arm_group.arm_group_type"
#>
#> $ctgov2
#> [1] "protocolSection.armsInterventionsModule.armGroups.type"
#>
#> $isrctn
#> [1] "trialDesign.studyDesign" "trialDesign.primaryStudyDesign"
#>
#> $ctis
#> [1] "authorizedPartI.productRoleGroupInfos.productRoleName"
#> [2] "authorizedApplication.authorizedPartI.productRoleGroupInfos.productRoleName"
#>
# 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(
field = "ctrname",
calculate = "f.controlType",
con = dbc)
#> To review trial concepts details, call 'help("ctrdata-trial-concepts")'
#> Querying database (14 fields)...
#> Typing fields...
#> Calculating f.controlType...
trialsDf
#> # A tibble: 25 × 3
#> `_id` ctrname .controlType
#> <chr> <chr> <fct>
#> 1 12949496 ISRCTN none
#> 2 13281214 ISRCTN none
#> 3 17473621 ISRCTN other
#> 4 2013-000615-24-BE EUCTR none
#> 5 2016-004489-24-DE EUCTR active
#> 6 2019-002663-10-ES EUCTR active
#> 7 2022-000099-20-DE EUCTR active
#> 8 2022-500244-37-00 CTIS placebo
#> 9 2023-505613-24-00 CTIS active
#> 10 2023-508143-51-01 CTIS active
#> # ℹ 15 more rows