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

View source: R/f_likelyPlatformTrial.R

f.likelyPlatformTrialR Documentation

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 has 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).

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

For EUCTR, requires that 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 0.77 or higher.

Publication references considered: EU-PEARL WP2 2020 and Williams RJ et al. 2022, \Sexpr[results=rd]{tools:::Rd_expr_doi("10.1136/bmj-2021-067745")}

Value

data frame with columns '_id' and '.likelyPlatformTrial', a logical, and two complementary columns, each with lists of identifiers: '.likelyRelatedTrials' (based on other identifiers provided in the trial record, including 'associatedClinicalTrials' from CTIS; listing identifiers whether or not the trial with the other identifier is in the database collection) and '.maybeRelatedTrials' (based on similar short terms in the first set of brackets or before a colon in the trial title; only listing identifiers from the database collection).

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 June 8, 2025, 10:45 a.m.