Calculate if study is likely a platform trial or not

Trial concept calculated: platform trial, research platform. As operational definition, at least one of these criteria is true: a. trial has "platform", "basket", "umbrella", "multi.?arm", "multi.?stage" or "master protocol" in its title or description (for ISRCTN, this is the only criterion; some trials in EUCTR lack data in English), b. trial has more than 2 active arms with different investigational medicines, after excluding comparator, auxiliary and placebo medicines (calculated with f.numTestArmsSubstances; not used for ISRCTN because it cannot be calculated precisely), c. trial more than 2 periods, after excluding safety run-in, screening, enrolling, extension and follow-up periods (for CTGOV and CTGOV2, this criterion requires results-related data). Requires that EUCTR results have been included in the collection, using ctrLoadQueryIntoDb(queryterm = ..., euctrresults = TRUE, con = ...). Requires packages dplyr and stringdist to be installed; stringdist is used for evaluating terms in brackets in the trial title, where trials may be related if the term similarity is 0.7 or higher.

Usage

f.likelyPlatformTrial(df = NULL)

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 `.likelyPlatformTrial`, a logical, `.likelyRelatedTrials`, a list (e.g., from CTIS' `associatedClinicalTrials`) and `.maybeRelatedTrials`, a list (based on similar short terms within a first set of brackets or before a colon in the title).

Details

Publication references considered: E-PEARL WP2 2020 https://tinyurl.com/eupearld21terminology (which did not include all basket trials in the definition, as done here) Williams RJ et al. 2022 https://doi.org/10.1136/bmj-2021-067745

Examples

# fields needed
f.likelyPlatformTrial()
#> [[1]]
#> [1] "ctrname"
#> 
#> $euctr
#> [1] "subjectDisposition.postAssignmentPeriods.postAssignmentPeriod.title"   
#> [2] "e824_number_of_treatment_arms_in_the_trial"                            
#> [3] "e81_controlled"                                                        
#> [4] "subjectDisposition.postAssignmentPeriods.postAssignmentPeriod.arms.arm"
#> [5] "a3_full_title_of_the_trial"                                            
#> 
#> $ctgov
#> [1] "clinical_results.participant_flow.period_list.period.title"
#> [2] "arm_group"                                                 
#> [3] "official_title"                                            
#> 
#> $ctgov2
#> [1] "resultsSection.participantFlowModule.periods.title"
#> [2] "protocolSection.armsInterventionsModule.armGroups" 
#> [3] "protocolSection.identificationModule.officialTitle"
#> 
#> $isrctn
#> [1] "interventions.intervention.interventionType"
#> [2] "trialDesign.secondaryStudyDesign"           
#> [3] "interventions.intervention.interventionType"
#> [4] "interventions.intervention.drugNames"       
#> [5] "trialDescription.scientificTitle"           
#> 
#> $ctis
#> [1] "title"                                                                                                 
#> [2] "authorizedPartI.trialDetails.protocolInformation.studyDesign.periodDetails.title"                      
#> [3] "authorizedApplication.authorizedPartI.trialDetails.protocolInformation.studyDesign.periodDetails.title"
#> [4] "authorizedPartI.productRoleGroupInfos"                                                                 
#> [5] "authorizedApplication.authorizedPartI.productRoleGroupInfos"                                           
#> [6] "authorizedPartI.trialDetails.clinicalTrialIdentifiers.fullTitle"                                       
#> [7] "authorizedApplication.authorizedPartI.trialDetails.clinicalTrialIdentifiers.fullTitle"                 
#> 

# 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.likelyPlatformTrial",
  con = dbc)
#> Querying database (23 fields)...
#> Searching for duplicate trials... 
#> - Getting all trial identifiers...
#> , 31 found in collection
trialsDf
#> # A tibble: 31 × 4
#>    `_id`           .likelyPlatformTrial .likelyRelatedTrials .maybeRelatedTrials
#>    <chr>           <lgl>                <list>               <list>             
#>  1 12949496        FALSE                <chr [1]>            <chr [1]>          
#>  2 13281214        FALSE                <chr [1]>            <chr [1]>          
#>  3 17473621        FALSE                <lgl [1]>            <chr [1]>          
#>  4 2012-003632-23… FALSE                <chr [2]>            <chr [1]>          
#>  5 2012-003632-23… FALSE                <chr [2]>            <chr [1]>          
#>  6 2014-002606-20… FALSE                <chr [1]>            <chr [1]>          
#>  7 2014-003556-31… FALSE                <chr [2]>            <chr [1]>          
#>  8 2014-003556-31… FALSE                <chr [2]>            <chr [1]>          
#>  9 2022-500244-37… FALSE                <lgl [1]>            <chr [1]>          
#> 10 2022-501142-30… FALSE                <lgl [1]>            <chr [1]>          
#> # ℹ 21 more rows