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First published 1998-1

Interpretation of Subgroup Analyses in Medical Device Clinical Trials *

Pamela E. Scott, Gregory Campbell

Therapeutic Innovation & Regulatory Science

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Research article

First published 2013-05

Analysis and Reporting of Sex Differences in Phase III Medical Device Clinical Trials—How Are We Doing?

Martha R. Nolan, Thuy-Linh Nguyen

Journal of Women's Health

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Research article

First published 1996-02

Clinical Trials in Support of Medical Devices

Richard Kotz

Journal of Integrative and Complementary Medicine

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Research article

First published 2017-12

An evaluation of the effectiveness of a risk-based monitoring approach implemented with clinical trials involving implantable cardiac medical devices

Christopher A Diani, Angie Rock, Phil Moll

Clinical Trials

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Research article

First published 2015-10

The Food and Drug Administration and pragmatic clinical trials of marketed medical products

Monique L Anderson, Joseph Griffin, Sara F Goldkind [...]

Clinical Trials

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Research article

First published 2012-9

Concepts for the Risk-Based Regulation of Clinical Research on Medicines and Medical Devices

Markus Hartmann, Florence Hartmann-Vareilles

Therapeutic Innovation & Regulatory Science

Open access

Research article

First published 2025

Impact of social determinants of health on safety of patients in device clinical trials conducted at a safety-net hospital

Anna C. Schneider, Katherine N. Cilley, Marina A. Malikova

Therapeutic Advances in Drug Safety

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Research article

First published 2017-5

In silico assessment of biomedical products: The conundrum of rare but not so rare events in two case studies

Marco Viceconti, Claudio Cobelli, Tarek Haddad [...]

Proceedings of the Institution of Mechanical Engineers,Part H: Journal of Engineering in Medicine

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Research article

First published 2015-2

Chapter 3 - Profit and non profit clinical trials

Diego Lorenzetti

Pharmaceuticals Policy and Law

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Review article

First published 2025-3

Navigating the evolving landscape: A review of clinical trial regulations in India

Ajit Jhuria, Diksha Nagpal, Ravinder Verma [...]

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

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