Evidence map›Paper›PMID 31957870›Full record

ArticleClinical pharmacology and therapeutics2020

Development of a System for Postmarketing Population Pharmacokinetic and Pharmacodynamic Studies Using Real-World Data From Electronic Health Records.

Leena Choi, Cole Beck, Elizabeth McNeer, Hannah L Weeks, Michael L Williams, Nathan T James, Xinnan Niu, Bassel W Abou-Khalil, Kelly A Birdwell, Dan M Roden and 4 more

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 21 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing 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

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

  1. Pooled it
  2. The Visual Predictive Check and Real-World Data.Clinical pharmacology and therapeutics · 2026
    Article
  3. Article
  4. Rising Role of Artificial Intelligence in Clinical Pharmacometrics and Model-Informed Precision Dosing in Pediatrics.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2026
    Article
  5. Review
  6. Article
  7. Article
  8. Article
  9. Article
  10. Review
  11. Article
  12. Article
  13. Article
  14. Review
  15. Article
  16. DrugWAS: Drug-wide Association Studies for COVID-19 Drug Repurposing.Clinical pharmacology and therapeutics · 2021
    Article
  17. Article
  18. Article
  19. Contemporary use of real-world data for clinical trial conduct in the United States: a scoping review.Journal of the American Medical Informatics Association : JAMIA · 2021
    Article
  20. Review
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

14 authors.

Leena ChoiDepartment of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Cole BeckDepartment of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Elizabeth McNeerDepartment of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Hannah L WeeksDepartment of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Michael L WilliamsDepartment of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Nathan T JamesDepartment of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Xinnan NiuDepartment of Biomedical Informatics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Bassel W Abou-KhalilDepartment of Neurology, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Kelly A BirdwellDepartment of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Dan M RodenDepartment of Biomedical Informatics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
C Michael SteinDepartment of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Cosmin A BejanDepartment of Biomedical Informatics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Joshua C DennyDepartment of Biomedical Informatics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Sara L Van DriestDepartment of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.

Funding

Understanding and preventing HLA-associated drug reactionsP50GM115305 · NIGMS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI RODEN, DAN M · 2015 to 2019
$13.0M
NRSA Training CoreTL1TR002244 · NCATS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI Julie A. Bastarache · 2017 to 2026
$4.6M
Pharmacogenetics to improve drug therapyR35GM131770 · NIGMS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI STEIN, CHARLES M. · 2019 to 2023
$1.7M
System construction for population pharmacokinetic and pharmacodynamic modeling using electronic health records: toward precision medicineR01GM124109 · NIGMS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI CHOI, LEENA · 2017 to 2021
$1.5M
Pharmacogenomics of Tacrolimus and New Onset Diabetes After Kidney TransplantK23GM100183 · NIGMS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI BIRDWELL, KELLY A · 2011 to 2015
$942k
Doris Duke Charitable Foundation 2017075NCATS NIH HHS TL1 TR002244NIGMS NIH HHS K23 GM100183NIGMS NIH HHS P50 GM115305NIGMS NIH HHS R01 GM124109NIGMS NIH HHS R35 GM131770
6 · The paper itself

Abstract

Postmarketing population pharmacokinetic (PK) and pharmacodynamic (PD) studies can be useful to capture patient characteristics affecting PK or PD in real-world settings. These studies require longitudinally measured dose, outcomes, and covariates in large numbers of patients; however, prospective data collection is cost-prohibitive. Electronic health records (EHRs) can be an excellent source for such data, but there are challenges, including accurate ascertainment of drug dose. We developed a standardized system to prepare datasets from EHRs for population PK/PD studies. Our system handles a variety of tasks involving data extraction from clinical text using a natural language processing algorithm, data processing, and data building. Applying this system, we performed a fentanyl population PK analysis, resulting in comparable parameter estimates to a prior study. This new system makes the EHR data extraction and preparation process more efficient and accurate and provides a powerful tool to facilitate postmarketing population PK/PD studies using information available in EHRs.

Indexed as

Data Interpretation, StatisticalAdolescentAdultAgedAnalgesics, OpioidDatabases, FactualElectronic Health RecordsFemaleFentanylHumansLamotrigineMaleMiddle AgedProduct Surveillance, PostmarketingTacrolimusYoung AdultAnalgesics, OpioidFentanylLamotrigineTacrolimus

Identifiers

PMID31957870
PMCPMC7093250

What OpenQuestion holds

Textmetadata
LicenceTDM
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 OpenQuestion graph.