Abstract
The objective of this chapter is to make a case for simulation-guided clinical trial design. It discusses the concept of adaptive dose-response finding studies with real-time learning about the research question, continuously updating the choice of treatment, and assessing whether to continue or terminate the trial. The most important result from clinical trial simulation is to give a realistic expectation of the likelihood of success of the trial. The chapter discusses a software package that allows both the simulation and the conduct of a real-time learning trial. It also presents an example of developing a neuroprotective treatment for acute ischemic stroke to develop the ideas on simulation-guided clinical trial design.
Original language | English (US) |
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Title of host publication | Handbook of Neuroemergency Clinical Trials |
Publisher | Elsevier Inc. |
Pages | 179-204 |
Number of pages | 26 |
ISBN (Print) | 9780126480825 |
DOIs | |
State | Published - 2006 |
ASJC Scopus subject areas
- General Biochemistry, Genetics and Molecular Biology