Evidence map›Paper›PMID 39116871›Full record

ReviewMed (New York, N.Y.)2024

Preclinical assessment for translation to humans: The PATH approach for assessing supporting evidence for early-phase trials and innovative care.

Jonathan Kimmelman, Patrick Bodilly Kane, Selin Bicer, Benjamin Gregory Carlisle

Abstract readReview
In one paragraph

Review in Med (New York, N.Y.), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing 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

9 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. Article
  5. Review
  6. Review
  7. Article
  8. Article
  9. 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

4 authors.

Jonathan KimmelmanDepartment of Equity, Ethics and Policy, Rm 1155, School of Population and Global Health, McGill University, 2001 McGill College, Montreal, QC H3A 1L7, Canada. Electronic address: jonathan.kimmelman@mcgill.ca.
Patrick Bodilly KaneDepartment of Equity, Ethics and Policy, Rm 1155, School of Population and Global Health, McGill University, 2001 McGill College, Montreal, QC H3A 1L7, Canada.
Selin BicerDepartment of Equity, Ethics and Policy, Rm 1155, School of Population and Global Health, McGill University, 2001 McGill College, Montreal, QC H3A 1L7, Canada.
Benjamin Gregory CarlisleDepartment of Equity, Ethics and Policy, Rm 1155, School of Population and Global Health, McGill University, 2001 McGill College, Montreal, QC H3A 1L7, Canada.

Funding

The RATIOS Study: Risk/benefit AssessmenT by IRB review of Phase One StudiesR01NS119622 · NINDS · UNIVERSITY OF CALIFORNIA AT DAVIS · PI FEDYK, MARK, KIMMELMAN, JONATHAN M · 2022 to 2024
$1.7M
NINDS NIH HHS R01 NS119622
6 · The paper itself

Abstract

Early-phase trials and innovative care draw support from basic science, preclinical studies, and clinical research. Such evidential diversity presents a challenge for traditional ways of synthesizing evidence. In what follows, we review the limitations of existing approaches for communicating supporting evidence for early-phase trials. We then offer a structured approach, PATH (preclinical assessment for translation to humans). PATH is grounded in the premise that the case for administering novel strategies to patients requires connecting the dots between nine mechanistic steps supporting a clinical claim. Using PATH entails first parsing supporting evidence, assessing the strength of evidence at each step, and then assessing the strength of a chain of evidence linking drug administration to clinical effect. While PATH requires further refinement, the approach reduces some of the opacity, arbitrariness, and biases in current ways of presenting and assessing scientific support for early-phase trials and innovative care.

Indexed as

Clinical Trials as TopicTranslational Research, BiomedicalAnimalsDrug Evaluation, PreclinicalEvidence-Based MedicineHumans

Identifiers

PMID39116871
PMCPMC11471378

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.