ArticleCurrent oncology (Toronto, Ont.)2026
Establishing a Clinical Trial Quality Team in a Comprehensive Cancer Center: A Strategy to Navigate the New European Regulatory Landscape.
Article in Current oncology (Toronto, Ont.), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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.
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.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Funding
Abstract
backgroundClinical research has evolved into a multidisciplinary field integrating Medical Devices (MD), In Vitro Diagnostics (IVD), and Artificial Intelligence (AI), governed by a modernized European regulatory framework including the Clinical Trial Regulation (CTR), the Medical Device Regulation (MDR), and the In Vitro Diagnostics Regulation (IVDR). In 2021, the Istituto Oncologico Veneto (IOV) IRCCS established the Clinical Trial Quality Team (CTQT) to provide support for non-profit trials and ensure high-quality standards.
methodsA descriptive analysis of trials managed between 2021 and 2025 was conducted using the REDCap platform. A team of 15 professionals assessed performance via Key Performance Indicators (KPIs) categorized into: ethical-regulatory compliance, operational efficiency and data quality.
resultsThe CTQT manages 18 studies (83% interventional, 50% multicentre), primarily focused on brain (17%) and genitourinary (23%) tumours. The mean time from internal feasibility to Ethics Committee discussion is 13 days. Total approval time (ethical and administrative) is 107 days. Operational metrics are strong, with Site Initiation Time averaging 27 days and First Patient In (FPI) at 41 days.
conclusionsA centralized, multidisciplinary structure effectively supports non-profit research in a complex regulatory environment. While operational speed is high, challenges such as staff turnover and query management variability remain. Future efforts will focus on standardizing post-approval administrative phases and optimizing data management to further improve trial efficiency and integrity.
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Registered trials
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.