Propensity‐score‐based priors for Bayesian augmented control design

Author:

Lin Junjing1,Gamalo‐Siebers Margaret2ORCID,Tiwari Ram3

Affiliation:

1. Abbvie North Chicago Illinois USA

2. Eli Lilly and Company Indianapolis Indiana USA

3. Division of BiostatisticsCenter for Devices and Radiological Health, Food, and Drug Administration Silver Spring Maryland USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Reference44 articles.

1. Food and Drug Administration.Guidance for industry: providing clinical evidence of effectiveness for human drug and biological products. Rockville MD;1998.

2. Hypothesis: A single clinical trial plus causal evidence of effectiveness is sufficient for drug approval

3. FDA.Use of real‐world evidence to support regulatory decision‐making for medical devices. Rockville MD;2016.

4. Multidimensional Evidence Generation and FDA Regulatory Decision Making

5. Bayesian approach to the design and analysis of non-inferiority trials for anti-infective products

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