Evidence map›Paper›PMID 39901671›Full record

ReviewReviews on recent clinical trials2025

Critical Analysis of Non-profit Clinical Trials: Three Years of Activity at the Clinical Trials Office.

Diego Alejandro Dri, Marta De Cata, Maria Carafa, Eleonora De Paola, Raffaella Maione, Paola Aita, Donatella Gramaglia

Abstract readReview
PubMed Publisher
In one paragraph

Review in Reviews on recent clinical trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

7 authors.

Diego Alejandro DriClinical Trials Office, Italian Medicines Agency (AIFA), Rome, Italy.ORCID 0000-0002-5110-3582
Marta De CataClinical Trials Office, Italian Medicines Agency (AIFA), Rome, Italy.ORCID 0009-0007-8575-7342
Maria CarafaDepartment of Chemistry and Technology of Drugs (DCTF), University of Rome "La Sapienza", Rome, Italy.
Eleonora De PaolaClinical Trials Office, Italian Medicines Agency (AIFA), Rome, Italy.
Raffaella MaioneClinical Trials Office, Italian Medicines Agency (AIFA), Rome, Italy.
Paola AitaClinical Trials Office, Italian Medicines Agency (AIFA), Rome, Italy.
Donatella GramagliaClinical Trials Office, Italian Medicines Agency (AIFA), Rome, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionNon-profit clinical trials submitted for authorization over three years to the Clinical Trials Office of the Italian Medicines Agency were reviewed and critically analyzed.

objectiveThe objectives are to highlight potential trends following the full implementation of Regulation (EU) No. 536/2014 and to reveal the different nuances of non-profit clinical trials, comparing them with the general profile of all clinical trials.

methodsUsing a multidisciplinary approach, the research navigates public data, official documents and data retrieved from the Italian National Observatory on Clinical Trials and from the European Clinical Trials Information System to reveal shifts in the clinical trials landscape.

resultsA decrease in non-profit applications submitted in the 2020-2022 timeframe is emerging, clearly related to the new regulatory complexities and uncertainties in the adoption of the Clinical Trials Information System platform. Results also show a divergence between nonprofit and overall clinical trials in terms of authorization outcomes, also including studies with a COVID-19 indication. Further comparing non-profit studies with the total number of clinical trials across different characteristics, such as phases, therapeutic areas and study purposes, increases transparency and availability of insight information.

conclusionRelevant data are provided as a result of the review and analysis of non-profit clinical trials, highlighting specific features. Overall, this critical analysis provides an overview of recent trends and, also promotes insights for further consideration by regulators to adequately support clinical research in a complex and evolving regulatory environment.

Indexed as

Clinical Trials as TopicOrganizations, NonprofitCOVID-19HumansItalyauthorization outcomes.Clinical trialsCOVID-19non-commercialnon-profitregulatory

Identifiers

What OpenQuestion holds

Textmetadata
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.