ctcovidstop: Clinical trials that stopped during the Covid-19 pandemic
Last updated on 2022-05-17
Provides a database of all ClinicalTrials.gov NCT Numbers corresponding to clinical trials that were "stopped" (had their overall status changed to "Terminated," "Suspended," or "Withdrawn") after 2019-12-01. This dataset indicates the date that a trial was stopped, whether it was started again and on what date, and the contents of the "why stopped?" field on the date the trial stopped. This dataset also includes columns with manually coded data for whether the "why stopped?" field explicitly indicates that the reason for stopping included the SARS-CoV-2 pandemic.
To install and use
Install from Github:
install.packages("devtools")
library(devtools)
install_github("bgcarlisle/ctcovidstop")
After installation:
library(ctcovidstop)
data(c19stoppedtrials)
This package provides a data frame, c19stoppedtrials
, which can be loaded
via the R package with data(c19stoppedtrials)
. The same data frame is
also provided as a CSV in this repository as
inst/extdata/c19stoppedtrials.csv
.
c19stoppedtrials
contains 8 columns. See below for example rows:
nctid |
stop_date |
stop_status |
restart_date |
restart_status |
why_stopped |
covid19_explicit |
restart_expected |
---|---|---|---|---|---|---|---|
NCT04007003 | 2019-12-02 | Terminated | NA | NA | Sponsor decision | FALSE | NA |
NCT03693833 | 2020-03-16 | Suspended | 2020-06-15 | Recruiting | COVID-19 | TRUE | FALSE |
NCT04161976 | 2020-04-20 | Suspended | 2020-06-03 | Recruiting | Enrollment on hold due to COVID-19 pandemic. | TRUE | TRUE |
Each row in this data frame contains an NCT Number from
ClinicalTrials.gov (nctid
column) and a date on which the
corresponding clinical trial record's overall status was first changed
to "Terminated", "Suspended" or "Withdrawn" from any other overall
status after 2019-12-01 (stop_date
column). The status that the
trial was changed to on that date is indicated in the stop_status
column.
A trial is only included if the study's overall status changed to "Terminated", "Suspended" or "Withdrawn" from any other overall status after 2019-12-01. If a trial's overall status was already "Terminated", "Suspended" or "Withdrawn" prior to 2019-12-01 and it never became active and then stopped after 2019-12-01, it would not be included, even if the "why stopped?" field was updated to include a reference to Covid-19 (e.g. NCT03365921).
If the trial started again (overall status changed from "Terminated",
"Suspended" or "Withdrawn" to any other overall status) after being
"stopped" according to the definition above by the date that this data
set was last updated, the date that the trial restarted is recorded
under restart_date
; otherwise this column contains NA. The status
that the stopped trial was changed to is indicated in the
restart_status
column.
The reason that the trial was stopped, as reported on the first
stopped historical version of the clinical trial registry entry on
ClinicalTrials.gov, is recorded in the why_stopped
field. If no
reason is given, this column contains NA.
If why_stopped
cites Covid-19 explicitly as a reason why the trial
was stopped, the covid19_explicit
column is TRUE, otherwise
FALSE. In the case that there is no value for why_stopped
,
covid19_explicit
is FALSE. This data point was manually rated by
BGC.
Trials that cite waning levels of Covid-19 infections, etc. as their
rationale for stopping were not considered to be stopped because of
Covid-19, and so covid19_explicit
would be FALSE
(e.g. NCT04390191).
The stop_date
, stop_status
and why_stopped
will reflect only the
first time the trial was stopped after 2019-12-01. In cases where a
trial stops after 2019-12-01 without citing Covid-19 in the
why_stopped
field, starts again, and then stops a second time,
citing Covid-19 as a reason why the study stopped
(e.g. NCT03728504), the trial's covid19_explicit
column is FALSE.
In cases where a trial was stopped with no rationale reported in the
version of the trial history where it was stopped, and then in a later
version, the why_stopped
field was updated to include a rationale,
the updated rationale for stopping would not be included in this data
set.
If covid19_explicit
is FALSE, restart_expected
is NA. If
covid19_explicit
is TRUE, and there is also a stated expectation
that the trial will start again in why_stopped
, restart_expected
is TRUE, otherwise FALSE. Trials that mention the study is "on hold"
or "expected to resume" or that the stop was "temporary", etc. were
included. This data point was manually rated by BGC.
ctcovidstop
Citing These data are provided under a Creative Commons by-attribution licence.
Here is a BibTeX entry for ctcovidstop
:
@Manual{ctcovidstop-carlisle,
Title = {ctcovidstop},
Author = {Carlisle, Benjamin Gregory},
Organization = {The Grey Literature},
Address = {Berlin, Germany},
url = {https://github.com/bgcarlisle/ctcovidstop},
year = 2022
}
If you use this data set and you found it useful, I would take it as a kindness if you cited it.
Best,
Benjamin Gregory Carlisle PhD