Evidence map›Paper›PMID 39198727›Full record

ArticleBMC medical research methodology2024

Feasibility of using real-world data to emulate substance use disorder clinical trials: a cross-sectional study.

Guneet S Janda, Molly Moore Jeffery, Reshma Ramachandran, Joseph S Ross, Joshua D Wallach

Abstract read
In one paragraph

Article in BMC medical research methodology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

5 authors.

Guneet S JandaYale School of Medicine, New Haven, CT, USA.
Molly Moore JefferyDivision of Health Care Delivery Research, Mayo Clinic, Rochester, MN, USA.
Reshma RamachandranSection of General Internal Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA.
Joseph S RossSection of General Internal Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA.
Joshua D WallachYale Collaboration for Regulatory Rigor, Integrity, and Transparency, Yale School of Medicine, New Haven, CT, USA. joshua.wallach@emory.edu.ORCID 0000-0002-9218-3320

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
Yale-Mayo FDA Center for Excellence in Regulatory Science and InnovationU01FD005938 · FDA · YALE UNIVERSITY · PI Joseph Solomon Ross · 2016 to 2026
$25.4M
Identifying Patient Subgroups That Are Most Likely To Benefit From Medications Used To Treat Alcohol Use DisorderK01AA028258 · NIAAA · YALE UNIVERSITY · PI WALLACH, JOSHUA DAVID · 2021 to 2025
$892k
NCATS NIH HHS UL1 TR001863NIAAA NIH HHS K01 AA028258
6 · The paper itself

Abstract

introductionReal-world evidence is receiving considerable attention as a way to evaluate the efficacy and safety of medical products for substance use disorders (SUDs). However, the feasibility of using real-world data (RWD) to emulate clinical trials evaluating treatments for SUDs is uncertain. The aim of this study is to identify the number of clinical trials evaluating treatments for SUDs with reported results that could be feasibly emulated using observational data from contemporary insurance claims and/or electronic health record (EHR) data.

methodsIn this cross-sectional study, all phase 2-4 trials evaluating treatments for SUDs registered on ClinicalTrials.gov with reported results were identified. Each trial was evaluated to determine if the indications, interventions, at least 80% of eligibility criteria, comparators, and primary end points could be ascertained using contemporarily available administrative claims and/or structured EHR data.

resultsThere were 272 SUD trials on ClinicalTrials.gov with reported results. Of these, when examining feasibility using contemporarily available administrative claims and/or structured EHR data, 262 (96.3%) had indications that were ascertainable; 194 (71.3%) had interventions that were ascertainable; 21 (7.7%) had at least 80% of eligibility criteria that were ascertainable; 17 (6.3%) had active comparators that were ascertainable; and 61 (22.4%) had primary end points that were ascertainable. In total, there were no trials for which all 5 characteristics were ascertainable using contemporarily available administrative claims and/or structured EHR data. When considering placebo comparators as ascertainable, there were 6 (2.2%) trials that had all 5 key characteristics classified as ascertainable from contemporarily available administrative claims and/or structured EHR data.

conclusionsNo trials evaluating treatments for SUDs could be feasibly emulated using contemporarily available RWD, demonstrating a need for an increase in the resolution of data capture within a public health system to facilitate trial emulation.

Indexed as

Electronic Health RecordsFeasibility StudiesSubstance-Related DisordersClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicClinical Trials, Phase IV as TopicCross-Sectional StudiesHumansReal-world evidenceSubstance use disordersTrial emulation

Identifiers

PMID39198727
PMCPMC11351457

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

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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 OpenQuestion graph.