Multiplicity Adjustment and Sample Size Calculation in Clinical Trials with Multiple Endpoints: An Industry Survey of Current Practices in Japan

Author:

Sakamaki Kentaro,Morita Yusuke,Iba Katsuhiro,Kamiura Toshifumi,Yoshida Seitaro,Ogawa Naoyuki,Suganami Hideki,Tsuchiya Satoru,Fukimbara Satoru

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Public Health, Environmental and Occupational Health,Pharmacology, Toxicology and Pharmaceutics (miscellaneous)

Reference26 articles.

1. Maher-Edwards G, Watson C, Ascher J, et al. Two randomized controlled trials of SB742457 in mild-to-moderate Alzheimer’s disease. Alzheimer’s Dementia. 2015;1:23–36.

2. Committee for Medicinal Products for Human Use. Guideline on the clinical investigation of medicines for the treatment of Alzheimer’s disease. https://www.ema.europa.eu/documents/scientific-guideline/guideline-clinical-investigation-medicines-treatment-alzheimers-disease-revision-2_en.pdf. Accessed 19 Feb 2019.

3. U.S. Food and Drug Administration. Multiple endpoints in clinical trials: draft guidance for industry. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM536750.pdf. Accessed 19 Feb 2019.

4. Hodi FS, Chiarion-Sileni V, Gonzalez R, et al. Nivolumab plus ipilimumab or nivolumab alone versus ipilimumab alone in advanced melanoma (CheckMate 067): 4-year outcomes of a multicentre, randomised, phase 3 trial. Lancet Oncol. 2018;19:1480–92.

5. Nakagawa K, Yang JH, Park K, et al. 481TiP Checkmate 722: a phase 3 trial of nivolumab with chemotherapy or ipilimumab vs chemotherapy in epidermal growth factor receptor (EGFR)-mutation, T790M-negative stage IV or recurrent non-small cell lung cancer (NSCLC) after EGFR tyrosine kinase inhibitor (TKI) therapy. Ann Oncol. 2016. https://doi.org/10.1093/annonc/mdw594.045.

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