Evidence map›Paper›PMID 33805639›Full record

ArticlePharmaceutics2021

Surfactants, Nanomedicines and Nanocarriers: A Critical Evaluation on Clinical Trials.

Diego Alejandro Dri, Carlotta Marianecci, Maria Carafa, Elisa Gaucci, Donatella Gramaglia

Abstract read
In one paragraph

Article in Pharmaceutics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing 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

8 citing papers in PubMed.

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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.

Diego Alejandro DriClinical Trials Office, Italian Medicines Agency (AIFA), Via del Tritone 181, 00187 Rome, Italy.ORCID 0000-0002-5110-3582
Carlotta MarianecciDepartment of Chemistry and Technology of Drugs (DCTF), University of Rome "La Sapienza", Piazzale Aldo Moro 5, 00185 Rome, Italy.ORCID 0000-0002-2505-1766
Maria CarafaDepartment of Chemistry and Technology of Drugs (DCTF), University of Rome "La Sapienza", Piazzale Aldo Moro 5, 00185 Rome, Italy.ORCID 0000-0002-3968-3385
Elisa GaucciClinical Trials Office, Italian Medicines Agency (AIFA), Via del Tritone 181, 00187 Rome, Italy.
Donatella GramagliaClinical Trials Office, Italian Medicines Agency (AIFA), Via del Tritone 181, 00187 Rome, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Advances, perspectives and innovation in drug delivery have increased in recent years; however, there is limited information available regarding the actual presence of surfactants, nanomedicines and nanocarriers in investigational medicinal products submitted as part of a request for authorization of clinical trials, particularly for those authorized in the European Economic Area. We retrieve, analyze and report data available at the Clinical Trial Office of the Italian Medicines Agency (AIFA), increasing the transparency and availability of relevant information. An analysis of quality documentation submitted along with clinical trials authorized by the AIFA in 2018 was carried out, focusing on the key terms "surfactant", "nanomedicine" and "nanocarrier". Results suggest potential indications and inputs for further reflection and actions for regulators to actively and safely drive innovation from a regulatory perspective and to transpose upcoming evolution of clinical trials within a strong regulatory framework.

Indexed as

clinical trialsnanocarriersnanomedicinesregulatorysurfactants

Identifiers

PMID33805639
PMCPMC7999832

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.