Evidence map›Paper›PMID 25537256›Full record

ArticleExpert review of clinical pharmacology2015

Optimizing early Go/No Go decisions in CNS drug development.

William Z Potter

Abstract readEditorial
In one paragraph

Article in Expert review of clinical pharmacology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing 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

7 citing papers in PubMed.

  1. Trial
  2. BIOMARKERS AND NEUROBEHAVIORAL DIAGNOSIS.Biomarkers in neuropsychiatry · 2021
    Article
  3. Review
  4. Review
  5. Recognizing that Evidence is Made, not Born.Clinical pharmacology and therapeutics · 2019
    Article
  6. Review
  7. 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

1 author.

William Z PotterNational Institute of Mental Health, Bethesda, MD.

Funding

Intramural NIH HHS Z99 MH999999
6 · The paper itself

Abstract

Go/No Go decisions concerning development of any single compound determine investment in increasingly costly studies from Phases I-III. Such decisions are problematic for CNS drug development where the variety of molecular targets in the brain have stimulated decades of studies without major therapeutic advances. Many costly studies do not even yield interpretable results as to whether the mechanism being pursued has therapeutic potential. Therefore, both industry and the public sector have implemented a decision making strategy based on whether a compound can test a molecular hypothesis of drug action. One requires, at a minimum, compelling evidence in humans that a compound both interacts with its presumed molecular targets in brain and ideally documents a CNS functional consequence of the interaction prior to efficacy studies. This strategy will much more quickly rule out ineffective mechanisms although it does not address the problem of poorly predictive models of novel CNS drug efficacy.

Indexed as

Decision MakingDrug DesignAnimalsCentral Nervous System AgentsClinical Trials as TopicDrug IndustryHumansModels, TheoreticalMolecular Targeted TherapyCentral Nervous System Agentsbrain target engagementCNS drug developmentGo/No Go decisionsmechanistic hypothesesRDoC

Identifiers

PMID25537256
PMCPMC4648539

What OpenQuestion holds

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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.