Evidence mapPaperPMID 32301116Full record

ArticleClinical pharmacology and therapeutics2020

Reweighting Randomized Controlled Trial Evidence to Better Reflect Real Life - A Case Study of the Innovative Medicines Initiative.

Michael Happich, Alan Brnabic, Douglas Faries, Keith Abrams, Katherine B Winfree, Allicia Girvan, Pall Jonsson, Joseph Johnston, Mark Belger, IMI GetReal Work Package 1

Abstract read
In one paragraph

Article in Clinical pharmacology and therapeutics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
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

8 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Model-based standardization using multiple imputation.BMC medical research methodology · 2024
    Article
  4. Article
  5. Article
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors.

Michael HappichLilly Research Centre, Eli Lilly and Company, Surrey, UK.
Alan BrnabicEli Lilly and Company, Sydney, New South Wales, Australia.
Douglas FariesLilly Corporate Center, Eli Lilly and Company, Indianapolis, Indiana, USA.
Keith AbramsDepartment of Health Sciences, University of Leicester, Leicester, UK.
Katherine B WinfreeLilly Corporate Center, Eli Lilly and Company, Indianapolis, Indiana, USA.
Allicia GirvanLilly Corporate Center, Eli Lilly and Company, Indianapolis, Indiana, USA.
Pall JonssonNational Institute for Health and Care Excellence (NICE), Manchester, UK.
Joseph JohnstonLilly Corporate Center, Eli Lilly and Company, Indianapolis, Indiana, USA.
Mark BelgerLilly Research Centre, Eli Lilly and Company, Surrey, UK.
IMI GetReal Work Package 1

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Evidence from randomized controlled trials available for timely health technology assessments of new pharmacological treatments and regulatory decision making may not be generalizable to local patient populations, often resulting in decisions being made under uncertainty. In recent years, several reweighting approaches have been explored to address this important question of generalizability to a target population. We present a case study of the Innovative Medicines Initiative to illustrate the inverse propensity score reweighting methodology, which may allow us to estimate the expected treatment benefit if a clinical trial had been run in a broader real-world target population. We learned that identifying treatment effect modifiers, understanding and managing differences between patient characteristic data sets, and balancing the closeness of trial and target patient populations with effective sample size are key to successfully using this methodology and potentially mitigating some of this uncertainty around local decision making.

Indexed as

Clinical Trials, Phase III as TopicEvidence-Based MedicineObservational Studies as TopicRandomized Controlled Trials as TopicResearch DesignTechnology Assessment, BiomedicalAgedData Interpretation, StatisticalFemaleHumansMaleMiddle AgedPropensity ScoreSample SizeTreatment Outcome

Identifiers

PMID32301116
PMCPMC7540324

What Socratic holds

Textmetadata
LicenceCC BY-NC
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.