A group‐sequential randomized trial design utilizing supplemental trial data

Author:

Kotalik Ales1ORCID,Vock David M.2,Hobbs Brian P.3ORCID,Koopmeiners Joseph S.2ORCID

Affiliation:

1. Biometrics, Late‐stage Development, Respiratory and Immunology (R&I) AstraZeneca BioPharmaceuticals R&D Gaithersburg Maryland USA

2. Division of Biostatistics, School of Public Health University of Minnesota Minneapolis Minnesota USA

3. Dell Medical School The University of Texas at Austin Austin Texas USA

Funder

National Cancer Institute

National Heart, Lung, and Blood Institute

National Institute on Drug Abuse

Publisher

Wiley

Subject

Statistics and Probability,Epidemiology

Reference51 articles.

1. Adaptive clinical trials in oncology

2. Adaptive Design Methods in Clinical Trials

3. Comments on the Draft Guidance on “Adaptive Design Clinical Trials for Drugs and Biologics” of the U.S. Food and Drug Administration

4. Food US.Food and drug administration. master protocols: efficient clinical trial design strategies to expedite development of oncology drugs and biologics guidance for industry‐draft guidance. draft guidance; 2018.

5. New “21st Century Cures” Legislation

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