Related Experiment Video
Updated: May 29, 2025

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
Critical Analysis of Non-profit Clinical Trials: Three Years of Activity at the Clinical Trials Office
Diego Alejandro Dri1, Marta De Cata1, Maria Carafa2
1Clinical Trials Office, Italian Medicines Agency (AIFA), Rome, Italy.
Introduction:
Non-profit clinical trials submitted for authorization over three years to the Clinical Trials Office of the Italian Medicines Agency were reviewed and critically analyzed.
Objective:
The 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.
Methods:
Using 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.
Results:
A 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.
Conclusion:
Relevant 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.
More Related Videos
06:05The Participant-Reported Implementation Update and Score PRIUS: A Novel Method for Capturing Implementation-Related Data Over Time
Published on: February 19, 2021
08:01Biobank for Translational Medicine: Standard Operating Procedures for Optimal Sample Management
Published on: November 30, 2022
Related Concept Videos
Clinical Trials
There are four phases in a clinical trial. A phase one...
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
Hazard Ratio
For example, in a clinical trial...
Comparing the Survival Analysis of Two or More Groups
Cancer Survival Analysis
Statistical Software for Data Analysis and Clinical Trials