Quantifying the feasibility of shortening clinical trial duration using surrogate markers

Author:

Wang Xuan1ORCID,Cai Tianxi12,Tian Lu3ORCID,Bourgeois Florence4,Parast Layla5ORCID

Affiliation:

1. Department of Biostatistics Harvard University Boston Massachusetts USA

2. Department of Biomedical Informatics Harvard University Boston Massachusetts USA

3. Department of Biomedical Data Science Stanford University Stanford California USA

4. Harvard‐MIT Center for Regulatory Science Boston Massachusetts USA

5. Statistics Group RAND Corporation Santa Monica California USA

Funder

National Institute of Diabetes and Digestive and Kidney Diseases

National Natural Science Foundation of China

Publisher

Wiley

Subject

Statistics and Probability,Epidemiology

Reference30 articles.

1. Generalized Competing Event Models Can Reduce Cost and Duration of Cancer Clinical Trials

2. Comparison of Sales Income and Research and Development Costs for FDA-Approved Cancer Drugs Sold by Originator Drug Companies

3. FDATable of surrogate endpoints that were the basis of drug approval or licensure; 2020.https://www.fda.gov/drugs/development‐resources/table‐surrogate‐endpoints‐we%re‐basis‐drug‐approval‐or‐licensure.

4. Surrogate endpoints in clinical trials: Definition and operational criteria

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