Utilizing restricted mean duration of response for efficacy evaluation of cancer treatments

Author:

Huang Bo1ORCID,Tian Lu2

Affiliation:

1. Pfizer Inc. Groton Connecticut USA

2. Stanford Medical School, Stanford University Stanford California USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Reference30 articles.

1. Statistical controversies in clinical research: end points other than overall survival are vital for regulatory approval of anticancer agents

2. Evaluation of Overall Response Rate and Progression-Free Survival as Potential Surrogate Endpoints for Overall Survival in Immunotherapy Trials

3. Progression-free survival is a suboptimal predictor for overall survival among metastatic solid tumour clinical trials

4. Guidance for Industry Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics;2018.https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-trial-endpoints-approval-cancer-drugs-and-biologics

5. Committee for Medicinal Products for Human Use.Guideline on the Evaluation of Anticancer Medicinal Products in Man. Rev. 6. EMA; 2020.https://www.ema.europa.eu/en/evaluation-anticancer-medicinal-products-man

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