Evidence mapPaperPMID 40979390Full record

ArticleFrontiers in drug safety and regulation2024

External comparator studies and the joint application of the estimand and target trial emulation frameworks.

Gerd Rippin, Héctor Sanz

Abstract read
In one paragraph

Article in Frontiers in drug safety and regulation, 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
field-weighted citation impact
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.

  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.

Gerd RippinIQVIA, Biostatistics, Frankfurt, Germany.
Héctor SanzIQVIA, Biostatistics, Barcelona, Spain.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The estimand framework (EF) and the target trial emulation framework (TTEF) are two important frameworks that can inform the design and analysis of external comparator (EC) studies. The EF helps clarifying the quantity to be estimated (the "estimand"), especially regarding the handling of post-baseline intercurrent events which interfere with the existence or interpretation of endpoints. Similarly, the TTEF is instrumental for specifying key design components of a hypothetical randomized trial and identifying which of these an EC study can and cannot emulate. We offer considerations about the joint application of both frameworks by combining the five EF attributes-

Indexed as

estimandsexternal comparator studiesexternal control arm studiesexternally controlled trialshistorical control studiestarget trial emulation

Identifiers

PMID40979390
PMCPMC12443083

What Socratic holds

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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.