Author: Qingyang Xu; Shomesh Chaudhuri; Danying Xiao; Andrew W Lo
Title: Bayesian Adaptive Clinical Trials for Anti-Infective Therapeutics during Epidemic Outbreaks Document date: 2020_4_14
ID: 20hk99h4_62
Snippet: While such a process may impose greater burdens on patients, manufacturers, and regulators, it may still be worthwhile if it brings faster or greater relief to patients facing mortal illnesses and extreme suffering. In this respect, an urgent-needs program may be viewed as a middle ground between a standard clinical trial and an approval, similar in spirit to the adaptive designs of sophisticated clinical trials with master protocols such as I-SP.....
Document: While such a process may impose greater burdens on patients, manufacturers, and regulators, it may still be worthwhile if it brings faster or greater relief to patients facing mortal illnesses and extreme suffering. In this respect, an urgent-needs program may be viewed as a middle ground between a standard clinical trial and an approval, similar in spirit to the adaptive designs of sophisticated clinical trials with master protocols such as I-SPY 2, LUNG-MAP, and GBM-AGILE, in which patient care and clinical investigations are simultaneously accomplished. Also, because the Centers for Medicare and Medicaid Services (CMS) has demonstrated a willingness to cover the cost of certain therapeutics for which evidence is still being generated (see, for example, CMS's "coverage with evidence" programs listed at https://go.cms.gov/2v6ZxWm), additional economic incentives may be available to support such temporary licenses.
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