Sage Journals: Discover world-class research

Retricted access

Review article

First published 2024-12

A comprehensive analysis of European clinical trial governance: The evolution from directive to regulation

Bhumika Maheriya, Tithi Patel, Rukshar Shaikh [...]

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector

Open access

Research article

First published 2025-8

Experiences with low-intervention clinical trials—the new category under the European Union Clinical Trials Regulation

Amos J. de Jong, Helga Gardarsdottir, Yared Santa-Ana-Tellez [...]

Clinical Trials

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Research article

First published 2015-2

Chapter 2 - Community intervention in the field of health and the European regulation of clinical trials on medicinal products for human use

Paolo De Angelis

Pharmaceuticals Policy and Law

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Research article

First published 2022-10

Risk-proportionate approach to paediatric clinical trials: The legal requirements,challenges,and the way forward under the European Union Clinical Trials Regulation

Mandy Wan, Elisa Alessandrini, Paul Brogan [...]

Clinical Trials

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Article commentary

First published 2021-10

Call for More Effective Regulation of Clinical Trials with Advanced Therapy Medicinal Products Consisting of or Containing Genetically Modified Organisms in the European Union

Alliance for Regenerative Medicine (ARM), European Federation of Pharmaceutical Industries and Associations (EFPIA), European Association for Bioindustries (EuropaBio) [...]

Human Gene Therapy

Open access

Review article

First published 2017

Publication of Clinical Trials Data: A New Approach to Transparency in the European Legislative Framework

Elisa Stefanini

The Journal of Medicine Access

Retricted access

Research article

First published 2010-2

Advanced Therapy: Rules and experiences of the Phase I Italian Competent Authority

Annarita Meneguz

Pharmaceuticals Policy and Law

Free access

Meeting report

First published 2007-9

Ethics of Research in Clinical Emergencies: UK Regulation Inconsistent with European Law

Michael F. Bone

Research Ethics

Retricted access

Other

First published 2010-5

Clinical Trial Disclosure: Global Overview and Implications of New Laws and Guidelines

Kathy B. Thomas, Merete Joergensen, Gerard Lynch [...]

Therapeutic Innovation & Regulatory Science

Open access

Research article

First published 2022-4

Trends and variation in data quality and availability on the European Union Clinical Trials Register: A cross-sectional study

Nicholas J DeVito, Ben Goldacre

Clinical Trials

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