Assessment of Pregabalin Postapproval Trials and the Suggestion of Efficacy for New Indications

Author:

Federico Carole A.1,Wang Taiji12,Doussau Adélaïde1,Mogil Jeffrey S.3,Fergusson Dean4,Kimmelman Jonathan1

Affiliation:

1. Studies of Translation, Ethics, and Medicine, Biomedical Ethics Unit, McGill University, Montreal, Quebec, Canada

2. School of Public Health, University of California, Berkeley, Berkeley

3. Departments of Psychology and Anesthesia, Alan Edwards Centre for Research on Pain, McGill University, Montreal, Quebec, Canada

4. Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada

Publisher

American Medical Association (AMA)

Subject

Internal Medicine

Reference49 articles.

1. The structure of clinical translation: efficiency, information, and ethics.;Kimmelman;Hastings Cent Rep,2015

2. Trials that say “maybe”: the disconnect between exploratory and confirmatory testing after drug approval.;Carlisle;BMJ,2018

3. Factors associated with postmarketing research for approved indications for novel medicines approved by both the FDA and EMA between 2005 and 2010: a multivariable analysis [published online January 29, 2018].;Zeitoun;Clin Pharmacol Ther

4. Seeding trials: just say “no”.;Sox;Ann Intern Med,2008

5. The ADVANTAGE seeding trial: a review of internal documents.;Hill;Ann Intern Med,2008

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