Changes are still needed on multiple co-primary endpoints

Author:

Chuang-Stein Christy1ORCID,Li Jianjun David2

Affiliation:

1. Chuang-Stein Consulting, LLC; U.S.A.

2. Statistics, Pfizer Inc.; U.S.A.

Publisher

Wiley

Subject

Statistics and Probability,Epidemiology

Reference19 articles.

1. FDA Draft Guidance for Industry Multiple Endpoints in Clinical Trials 2017 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM536750.pdf

2. FDA Presentations at the April 14 2015 Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee 2015 http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/ucm444143.htm

3. Multiple co-primary endpoints: medical and statistical solutions;Offen;Drug Information Journal,2007

4. FDA Guidance for Industry. Migraine: Developing Drugs for Acute Treatment 2014 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM419465.pdf

5. FDA Draft Guidance for Industry Estrogen and estrogen/progestin drug products to treat vasomotor symptoms and vulvar and vaginal atrophy symptoms-recommendations for clinical evaluation 2003 https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM071643.pdf

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