Evidence map›Paper›PMID 39852766›Full record

ArticleNeurology international2024

Leaflet: Operative Steps for Interventional Studies in Neuroscience.

Maria Meringolo, Sergio Delle Monache, Giuseppina Martella, Antonella Peppe

Abstract read
In one paragraph

Article in Neurology international, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Maria MeringoloSanta Lucia Foundation, IRCCS Fondazione Santa Lucia, 00179 Rome, Italy.
Sergio Delle MonacheSanta Lucia Foundation, IRCCS Fondazione Santa Lucia, 00179 Rome, Italy.ORCID 0000-0002-4210-2545
Giuseppina MartellaSanta Lucia Foundation, IRCCS Fondazione Santa Lucia, 00179 Rome, Italy.ORCID 0000-0002-8927-7107
Antonella PeppeSanta Lucia Foundation, IRCCS Fondazione Santa Lucia, 00179 Rome, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND/

objectivesDrug development involves multiple stages, spanning from initial discovery to clinical trials. This intricate process entails understanding disease mechanisms, identifying potential drug targets, and evaluating the efficacy and safety of candidate drugs. Clinical trials are designed to assess the effects of drugs on humans, focusing on determining safety profiles, appropriate modes of administration, and comparative efficacy against placebos. Notably, neuroscience drug development encounters distinct challenges, including the complex nature of diseases, limitations imposed by the blood-brain barrier, the absence of reliable predictive preclinical models, and regulatory hurdles. Ethical and safety considerations are pivotal due to the potential cognitive and motor effects of CNS-active drugs.

methodsOur manuscript outlines the procedures for CNS clinical trials and highlights the key elements of study design, methodological considerations, and ethical frameworks. To achieve our objectives, we considered the official websites of regulatory authorities, the EQUATOR network, and recent publications in the field. The paper includes key elements such as criteria for subject selection, methods of evaluation, variable analysis, and statistical methodology approaches.

resultsWe want to furnish a concise and comprehensive guide tailored to individuals new to CNS clinical trials, providing foundational elements necessary for the design and execution of such trials. The manuscript seeks to outline sources of relevant materials and elucidate adaptability, particularly in instances where sponsors may be absent.

conclusionsBy meeting the needs of less-experienced researchers or those with limited resources, the intention is to facilitate an understanding of the intricate nature of the process and offer guidance on appropriately navigating its complexities. It is essential to note that this manuscript does not aim to be exhaustive but endeavors to serve as a structured checklist. Through its approach, the manuscript aspires to offer guidance and support to individuals navigating the challenges inherent in this intricate domain.

Indexed as

clinical trialsenrollmenthealthlaw proceduresnon-commercial clinical trialspackagingpatientsregulatory agenciesstatistical approachstudy design

Identifiers

PMID39852766
PMCPMC11767703

What OpenQuestion holds

Textmetadata
LicenceCC BY
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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.