f.likelyPlatformTrial: Calculate if study is likely a platform trial or not

In ctrdata: Retrieve and Analyze Clinical Trials Data from Public Registers

Calculate if study is likely a platform trial or not

Description

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.

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

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).

Examples

# fields needed
f.likelyPlatformTrial()

# 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)
trialsDf

ctrdata documentation built on April 15, 2025, 1:34 a.m.