Pediatric and Adult Placebo Response Rates in Placebo‐Controlled Clinical Trials Submitted to the US Food and Drug Administration 2012

Pediatric and Adult Placebo Response Rates in Placebo‐Controlled Clinical Trials Submitted to the US Food and Drug Administration 2012–2020

Published:2022-03-11 Issue:8 Volume:62 Page:970-982
ISSN:0091-2700
Container-title:The Journal of Clinical Pharmacology
language:en
Short-container-title:The Journal of Clinical Pharma

Author:

Park Kyunghun¹^ORCID,Tran Ngan K.²,Momper Jeremiah D.³,Green Dionna J.⁴,Burckart Gilbert J.¹^ORCID

Affiliation:

1. Office of Clinical Pharmacology Office of Translational Sciences US Food and Drug Administration Silver Spring Maryland USA

2. School of Pharmacy University of Southern California Los Angeles California USA

3. Skaggs School of Pharmacy and Pharmaceutical Sciences University of California, San Diego La Jolla California USA

4. Office of Pediatric Therapeutics Office of the Commissioner US Food and Drug Administration Silver Spring Maryland USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/jcph.2035

Reference19 articles.

1. Migraine Therapeutics in Adolescents

2. US Food and Drug Administration:Guidance for Industry: E 10 Choice of Control Group and Related Issues in Clinical Trials 2001. Access at:https://www.fda.gov/media/71349/download(accessed on June 11 2021).

3. Ethical Considerations for Pediatric Placebo-Controlled Trials: FDA Outcomes and Perspectives

4. Traditional and Innovative Experimental and Clinical Trial Designs and Their Advantages and Pitfalls

5. Impact of Pediatric Exclusivity on Drug Labeling and Demonstrations of Efficacy

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