Evidence map›Paper›PMID 28925064›Full record

ArticleCPT: pharmacometrics & systems pharmacology2017

Improving Realism in Clinical Trial Simulations via Real-World Data.

Holly Kimko, Kwan Lee

Open access · goldAbstract read
In one paragraph

Article in CPT: pharmacometrics & systems pharmacology, 2017. 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
2.0field-weighted citation impact, top 12% 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, 12 citations in OpenAlex.

  1. Article
  2. Simulating Colorectal Cancer Trials Using Real-World Data.JCO clinical cancer informatics · 2022
    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 1 institution in 1 country.

Holly KimkoQuantitative Sciences, Janssen R&D, LLC, Spring House, Pennsylvania, USA.
Kwan LeeQuantitative Sciences, Janssen R&D, LLC, Spring House, Pennsylvania, USA.
Janssen (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Simulation validity depends on how well sampling distributions used reflect real-patient characteristics, such as drug adherence, disease progression, and pharmacologic handling in the body. We challenge the current use of growth charts from nondisease-specific pediatrics in simulations for drug development. Complementary use of data from clinical trials and the real-world is expected to achieve a more realistic representation of clinical outcomes for decisions in drug development, regulatory approval, and health technology assessment.

Indexed as

Clinical Trials as TopicComputer SimulationDrug DiscoveryHumansPharmacokinetics

Identifiers

PMID28925064
PMCPMC5702896
OpenAlexW2754045346

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
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.