Non-profit research: an insight into the management and monitoring of clinical trials in Italy

The survey highlights major challenges faced by non-profit sponsors in meeting regulatory expectations. Limited resources and a lack of trained personnel significantly impair compliance with GCP standards. To ensure research integrity and patient safety, targeted support strategies and policy interventions are urgently needed to empower non-profit research in adapting to the evolving regulatory landscape.

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Publication Details

Journal
Global & Regional Health Technology Assessment
Published
2026-03-13
DOI
https://doi.org/10.33393/grhta.2026.3668
Primary Topic
Ethics in Clinical Research
Type
article
Field-Weighted Citation Impact
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article

Non-profit research: an insight into the management and monitoring of clinical trials in Italy

Sara Lega, Barbara Bonifacio, Silvia Tommasi, Viviana Appolloni et al.
Global & Regional Health Technology Assessment
Ethics in Clinical Research
article

Non-profit research: an insight into the management and monitoring of clinical trials in Italy

Sara Lega, Barbara Bonifacio, Silvia Tommasi, Viviana Appolloni, Celeste Cagnazzo, Fatima Tizi
article en

Abstract

The survey highlights major challenges faced by non-profit sponsors in meeting regulatory expectations. Limited resources and a lack of trained personnel significantly impair compliance with GCP standards. To ensure research integrity and patient safety, targeted support strategies and policy interventions are urgently needed to empower non-profit research in adapting to the evolving regulatory landscape.

Global & Regional Health Technology AssessmentVol. 13(1)
IRCCS Materno Infantile Burlo Garofolo (IT), Azienda Ospedaliera Citta' della Salute e della Scienza di Torino (IT), Italian Sarcoma Group (IT), Ospedale Regina Margherita (IT)
Partnerships for the goals
Openalex Percentile: Top 24%
Ethics in Clinical Research
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Non-profit research: an insight into the management and monitoring of clinical trials in Italy — Sara Lega, Barbara Bonifacio, et al. · Global & Regional Health Technology Assessment (2026) | TGRS Research Map | TGRS