Evidence map›Paper›PMID 38486299›Full record

ArticleTrials2024

Trials that turn from retrospectively registered to prospectively registered: a cohort study of "retroactively prospective" clinical trial registration using history data.

Martin Holst, Benjamin Gregory Carlisle

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
2.8field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

2 authors at 2 institutions in 2 countries.

Martin HolstBerlin Institute of Health at Charité - Universitätsmedizin Berlin, QUEST Center for Responsible Research, Anna-Louisa-Karsch-Str. 2, 10178, Berlin, Germany. martin.holst@bih-charite.de.ORCID http://orcid.org/0000-0002-8135-6265
Benjamin Gregory CarlisleBerlin Institute of Health at Charité - Universitätsmedizin Berlin, QUEST Center for Responsible Research, Anna-Louisa-Karsch-Str. 2, 10178, Berlin, Germany.ORCID http://orcid.org/0000-0001-8975-0649
Berlin Institute of Health at Charité - Universitätsmedizin Berlin · DEMedizinische Hochschule Hannover · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundProspective registration of clinical trials is mandated by various regulations. However, clinical trial registries like ClinicalTrials.gov allow registry entries to be updated at any time, and key study elements, including the start date, may change before the first patient is enrolled. If a trial changes its start date after recruiting began, however, it may indicate a reason for concern. This study aimed to measure the rate of "retroactively prospective" trials. This refers to trials that are originally registered retrospectively, with the start date before the registration date, but that retroactively change their start date to be after the registration date, making them appear as if they were prospectively registered.

methodsWe retrieved clinical trial history data for all clinical trials registered on ClinicalTrials.gov with a first registration date in the year 2015 (N = 11,908). Using automated analyses, we determined the timepoints of registration in relation to the start date of the trial over time. For retroactively prospective trials and a set of control trials, we manually checked the accompanying publications to determine which start date they report and whether they report changes to the start date.

resultsWe found 235 clinical trials to be retroactively prospective, comprising 2.0% of all clinical trials in our sample of 11,908 trials. Among the 113 retroactively prospective clinical trials with an accompanying publication, 12 (10.6%) explicitly stated in the publication that they had been prospectively registered.

conclusionsRetroactively prospective trial registration happens in one in 50 trials. While these changes to the start date could be mistakes or legitimate edits based on the most up-to-date information, they could also indicate a retrospectively registered trial that has been made to appear as a prospectively registered trial, which would lead to biases unapparent to reviewers. Our results point to the need for more transparent reporting of changes to a trial's details and have implications for the review and conduct of clinical trials, with our fully automated and freely available tools allowing reviewers or editors to detect these changes.

trial registrationThe preregistered protocol of our study is available via https://osf.io/rvq53 . The most recent version of the protocol lists all deviations from the original study plan, including the rationale behind the changes, and additional analyses that were conducted.

Indexed as

Cohort StudiesHumansProspective StudiesRegistriesClinical trialsMeta-researchRetroactively prospective trial registrationStart dateTrial registries

Identifiers

PMID38486299
PMCPMC10938677
OpenAlexW4392806605

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.