Evidence map›Paper›PMID 37620252›Full record

ReviewClinical pharmacology and therapeutics2023

A Multistakeholder Perspective on Advancing Individualized Therapeutics.

Michael Pacanowski, Julia Vitarello, Insoo Hyun, Timothy Yu, Issam Zineh

Abstract readReview
In one paragraph

Review in Clinical pharmacology and therapeutics, 2023. 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
–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

3 citing papers in PubMed.

  1. Review
  2. Review
  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

5 authors.

Michael PacanowskiU.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of Translational Sciences, Office of Clinical Pharmacology, Silver Spring, Maryland, USA.
Julia VitarelloMila's Miracle Foundation, Boulder, Colorado, USA.
Insoo HyunHarvard Medical School, Center for Bioethics, Boston, Massachusetts, USA.
Timothy YuN=1 Collaborative, Somerville, Massachusetts, USA.
Issam ZinehU.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of Translational Sciences, Office of Clinical Pharmacology, Silver Spring, Maryland, USA.

Funding

Providing ethical guidance for the development of individualized genomic medicine as rare as n-of-1R01HG012247 · NHGRI · BOSTON CHILDREN'S HOSPITAL · PI BUSH, LYNN WEIN, HOLM, INGRID ADELE · 2022 to 2025
$3.0M
Intramural FDA HHS FD999999NHGRI NIH HHS R01 HG012247
6 · The paper itself

Abstract

Precision medicine has evolved from the application of pharmacogenetic biomarkers to the prospective development of targeted therapies in patients with specific molecular/genetic subtypes of disease to truly "N-of-1" medicines targeted to very small numbers of patients - in some cases, a single identified patient. This latter iteration of precision medicine presents unprecedented opportunities for patients with severe, life-threatening, or life-limiting diseases. At the same time, these modalities present complex scientific, clinical, and regulatory challenges. To realize the promise of individualized medicines, a multistakeholder approach to streamlining medical diagnoses, advancing the technologies that enable development of these therapeutic modalities, and re-envisioning collaborative environments for access and evidence generation is of critical importance. Herein, we highlight some of these challenges and opportunities.

Indexed as

PharmacogeneticsPrecision MedicineHumansProspective Studies

Identifiers

PMID37620252
PMCPMC10592009

What OpenQuestion holds

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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.