Design and implementation of an adaptive confirmatory trial in Japanese patients with palmoplantar pustulosis

Author:

Zheng RichuanORCID,Ito Yoichi M.ORCID,Yunoki Motonari,Minoda Kazuki,Nobeyama Soyoku

Publisher

Elsevier BV

Subject

Pharmacology,General Medicine

Reference22 articles.

1. Adaptive approaches in clinical drug development: opportunities and challenges in design and implementation;Krams;Pharm. Med. (Hamps.),2009

2. Barriers and opportunities for implementation of adaptive designs in pharmaceutical product development;Quinlan;Clin. Trials,2010

3. Benefits, challenges and obstacles of adaptive clinical trial designs;Chow;Orphanet J. Rare Dis.,2011

4. Adaptive design clinical trials: a review of the literature and ClinicalTrials.gov;Bothwell;BMJ Open,2018

5. Japan Pharmaceuticals and Medical Devices Agency (PMDA): Guideline on Data Monitoring Committee https://www.pmda.go.jp/files/000157932.pdf (April 4, 2013). Accessed 9 June 2019.

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1. Application of sample size re-estimation in clinical trials: A systematic review;Contemporary Clinical Trials Communications;2023-12

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