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"
#>
# 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)
#> Querying database (16 fields)...
trialsDf
#> _id ctrname .controlType
#> 1 12949496 ISRCTN none
#> 2 13281214 ISRCTN none
#> 3 17473621 ISRCTN other
#> 4 2012-003632-23-CZ EUCTR none
#> 5 2012-003632-23-SE EUCTR none
#> 6 2014-002606-20-PT EUCTR none
#> 7 2014-003556-31-GB EUCTR none
#> 8 2014-003556-31-SE EUCTR none
#> 9 2022-500244-37-00 CTIS placebo
#> 10 2022-501142-30-00 CTIS active
#> 11 2023-505613-24-00 CTIS none
#> 12 2023-508143-51-01 CTIS none
#> 13 2024-510663-34-00 CTIS none
#> 14 20343063 ISRCTN placebo
#> 15 61070850 ISRCTN other
#> 16 76463425 ISRCTN other
#> 17 80181452 ISRCTN placebo
#> 18 88261002 ISRCTN placebo
#> 19 NCT00617929 CTGOV2 none
#> 20 NCT01125800 CTGOV2 none
#> 21 NCT01483820 CTGOV2 none
#> 22 NCT01505608 CTGOV2 active
#> 23 NCT01592045 CTGOV2 none
#> 24 NCT02620761 CTGOV placebo
#> 25 NCT03280147 CTGOV active
#> 26 NCT03325439 CTGOV none
#> 27 NCT03431558 CTGOV placebo
#> 28 NCT03876704 CTGOV active
#> 29 NCT04001712 CTGOV active
#> 30 NCT04041765 CTGOV placebo
#> 31 NCT05969327 CTGOV no-treatment