Predictive Evidence Threshold Scaling: Does the Evidence Meet a Confirmatory Standard?-Reference-Cited by-同舟云学术

Predictive Evidence Threshold Scaling: Does the Evidence Meet a Confirmatory Standard?

Published:2018-04-03 Issue:2 Volume:10 Page:76-84
ISSN:1946-6315
Container-title:Statistics in Biopharmaceutical Research
language:en
Short-container-title:Statistics in Biopharmaceutical Research

Author:

Neuenschwander Beat¹,Roychoudhury Satrajit²,Branson Michael¹

Affiliation:

1. Novartis Pharma AG, Basel, Switzerland

2. Novartis Pharmaceuticals, East Hanover, NJ

Publisher

Informa UK Limited

Subject

Pharmaceutical Science,Statistics and Probability

Link

https://www.tandfonline.com/doi/pdf/10.1080/19466315.2017.1392892

Reference37 articles.

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2. From adaptive licensing to adaptive pathways: Delivering a flexible life‐span approach to bring new drugs to patients

3. “Threshold‐crossing”: A Useful Way to Establish the Counterfactual in Clinical Trials?

4. EMEA’s Committee for Medicinal Products for Human Use (CHMP) (2006), “Guideline on Clinical Trials in Small Populations,” available at http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003615.pdf

5. EMEA’s Committee for Proprietary Medicinal Products (CPMP) (2001), “Note for Guidance on Clinical Investigation of Medicinal Products in the Paediatric Population,” available at http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002926.pdf.

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1. Comment on “The Role of p-Values in Judging the Strength of Evidence and Realistic Replication Expectations”;Statistics in Biopharmaceutical Research;2020-11-05

2. A roadmap to using historical controls in clinical trials – by Drug Information Association Adaptive Design Scientific Working Group (DIA-ADSWG);Orphanet Journal of Rare Diseases;2020-03-12