Evidence map›Paper›PMID 40200755›Full record

SynthesisPharmacogenomics

Utilization of polygenic risk scores in drug development protocols.

Michelle A Pressly, Robert Schuck, Padmaja Mummaneni, Youssef M Roman, Michael Pacanowski

Abstract readSystematic Review
In one paragraph

Synthesis in Pharmacogenomics. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Article
  2. 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

5 authors.

Michelle A PresslyDivision of Translational and Precision Medicine, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, U.S. Food & Drug Administration, Silver Spring, MD, USA.ORCID 0000-0003-3667-9003
Robert SchuckDivision of Translational and Precision Medicine, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, U.S. Food & Drug Administration, Silver Spring, MD, USA.
Padmaja MummaneniDivision of Translational and Precision Medicine, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, U.S. Food & Drug Administration, Silver Spring, MD, USA.
Youssef M RomanDivision of Translational and Precision Medicine, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, U.S. Food & Drug Administration, Silver Spring, MD, USA.ORCID 0000-0002-0613-5534
Michael PacanowskiDivision of Translational and Precision Medicine, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, U.S. Food & Drug Administration, Silver Spring, MD, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The development of polygenic risk scores (PRSs), which make use of genetic testing to assess an individual's risk of developing certain diseases or conditions based on collective genetic variant information, can be applied in drug development to enrich clinical trials or predict response to treatment. From querying documents submitted to the Food & Drug Administration, the landscape of use of PRSs across time shows increased use in guiding clinical trials. Of the clinical trial protocols submitted, most were in the therapeutic areas of neurology, radiology (imaging and diagnostic pharmaceuticals), psychiatry, and oncology. Use of PRSs in clinical trials is most frequent in early drug development (phase 1, phase 1/2, or phase 3) and generally supports secondary or exploratory analyses. Additionally, about half of the protocols developed novel PRSs, and the other half used preexisting PRSs. As researchers, regulators, and clinicians aim to understand the results and implications of PRSs in clinical trials, the continued use of PRSs, despite being less common, reinforces the need for further exploration.

Indexed as

Drug DevelopmentMultifactorial InheritanceClinical Trials as TopicGenetic Predisposition to DiseaseGenetic Risk ScoreGenetic TestingHumansRisk FactorsUnited States Food and Drug Administrationdrug developmentpharmacogenomicsPolygenic risk scoreregulatory sciencetrial design

Identifiers

PMID40200755
PMCPMC12118405

What Socratic holds

Textmetadata
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.