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Research article

First published 1996-4

Methodological Issues in Pivotal Trials: Discussion

Susan Ellenberg

Therapeutic Innovation & Regulatory Science

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Research article

First published 2026-2

Confirmatory evidence supporting single pivotal trial new drug approvals by the Food and Drug Administration,2015 through 2023

Carla Barile Godoy, Reshma Ramachandran, Pradyumna Sapre [...]

Clinical Trials

Open access

Research article

First published 2021-1

Regulators,Pivotal Clinical Trials,and Drug Regulation in the Age of COVID-19

Joel Lexchin, Janice Graham, Matthew Herder [...]

International Journal of Social Determinants of Health and Health Services

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Research article

First published 2025-6

Pivotal trial characteristics and types of endpoints used to support Food and Drug Administration rare disease drug approvals between 2013 and 2022

Kyungwan Hong, Bridget Nugent, Abbas Bandukwala [...]

Clinical Trials

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Research article

First published 2019-6

Globalization of clinical trials: Variation in estimated regional costs of pivotal trials,2015–2016

Yao Qiao, G Caleb Alexander, Thomas J Moore

Clinical Trials

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Research article

First published 2020-4

Estimated costs of pivotal trials for U.S. Food and Drug Administration–approved cancer drugs,2015–2017

Emily Han-Chung Hsiue, Thomas J Moore, G Caleb Alexander

Clinical Trials

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Research article

First published 2022-07-05

Restoring the two pivotal fluoxetine trials in children and adolescents with depression

Peter C. Gøtzsche, David Healy

International Journal of Risk & Safety in Medicine

Free access

Research article

First published 2012-8

Linagliptin for type 2 diabetes mellitus: a review of the pivotal clinical trials

Janet B. McGill

Therapeutic Advances in Endocrinology and Metabolism

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Research article

First published 2020-8

Effects of pivotal response treatment on reciprocal vocal contingency in a randomized controlled trial of children with autism spectrum disorder

Jena McDaniel, Paul Yoder, Madison Crandall [...]

Autism

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Research article

First published 2020-8

Classroom Pivotal Response Teaching: Teacher Training Outcomes of a Community Efficacy Trial

Jessica Suhrheinrich, Sarah R. Rieth, Kelsey S. Dickson [...]

Teacher Education and Special Education: The Journal of the Teacher Education Division of the Council for Exceptional Children

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