5. What are Master Protocol and Pragmatic Trials? ~Let's learn about various recent clinical trial designs~

Author:

SAKAI Hironori1

Affiliation:

1. Data Science Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association

Publisher

Japanese Society of Clinical Pharmacology and Therapeutics

Reference15 articles.

1. 1) FDA Critical Path Opportunity Repot (2006). [https://wayback.archive-it.org/7993/20180125142845/https://www.fda.gov/downloads/ScienceResearch/SpecialTopics/CriticalPathInitiative/CriticalPathOpportunitiesReports/UCM077254.pdf (accessed 2024-05-07)]

2. 2) FDA Critical Path Opportunity List (2006). [https://wayback.archive-it.org/7993/20180125035449/https://www.fda.gov/downloads/ScienceResearch/SpecialTopics/CriticalPathInitiative/CriticalPathOpportunitiesReports/UCM077258.pdf (accessed 2024-05-07)]

3. 3) FDA Adaptive Design Clinical Trials for Drugs and Biologics Guidance for Industry (2020). [https://www.fda.gov/regulatory-information/search-fda-guidance-documents/adaptive-design-clinical-trials-drugs-and-biologics-guidance-industry(accessed 2024-05-07)]

4. 4) Krams M, Lees KR, Hacke W, Grieve AP, Orgogozo J-M, Ford GA. Acute Stroke Therapy by Inhibition of Neutrophils (ASTIN): an adaptivedose-response study of UK-279,276 in acute ischaemic stroke. Stroke. 2003; 34(11): 2543-48. doi : 10.1161/01.STR.0000092527.33910.89.

5. 5) Master Protocols : Efficient Clinica Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics, Guidance for Industry(2023). [https://www.fda.gov/regulatory-information/search-fda-guidance-documents/master-protocols-efficient-clinical-trial-design-strategies-expedite-development-oncology-drugs-and(accessed 2024-05-07)]

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