Dri Diego Alejandro, De Cata Marta, Carafa Maria, De Paola Eleonora, Maione Raffaella, Aita Paola, Gramaglia Donatella
Clinical Trials Office, Italian Medicines Agency (AIFA), Rome, Italy.
Department of Chemistry and Technology of Drugs (DCTF), University of Rome "La Sapienza", Rome, Italy.
Rev Recent Clin Trials. 2025 Jan 31. doi: 10.2174/0115748871310179250109065608.
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.
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.
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.
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.
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.
对提交至意大利药品管理局临床试验办公室三年以上以获得授权的非营利性临床试验进行了审查和批判性分析。
目的是突出2014年第536/2014号（欧盟）法规全面实施后的潜在趋势，并揭示非营利性临床试验的不同细微差别，将其与所有临床试验的总体概况进行比较。
该研究采用多学科方法，梳理公共数据、官方文件以及从意大利国家临床试验观察站和欧洲临床试验信息系统检索到的数据，以揭示临床试验格局的变化。
2020 - 2022年期间提交的非营利性申请数量呈下降趋势，这显然与采用临床试验信息系统平台时新出现的监管复杂性和不确定性有关。结果还显示，在授权结果方面，非营利性临床试验与总体临床试验存在差异，这也包括有新冠病毒疾病适应症的研究。进一步将非营利性研究与不同特征（如阶段、治疗领域和研究目的）的临床试验总数进行比较，可提高洞察信息的透明度和可得性。
通过对非营利性临床试验的审查和分析得出了相关数据，突出了其特定特征。总体而言，这一批判性分析概述了近期趋势，也为监管机构进一步思考提供了见解，以便在复杂且不断演变的监管环境中充分支持临床研究。
