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A generalized phase 1-2-3 design integrating dose optimization with confirmatory treatment comparison.
- Source :
-
Biometrics . Mar2024, Vol. 80 Issue 1, p1-12. 12p. - Publication Year :
- 2024
-
Abstract
- A generalized phase 1-2-3 design, Gen 1-2-3, that includes all phases of clinical treatment evaluation is proposed. The design extends and modifies the design of Chapple and Thall (2019), denoted by CT. Both designs begin with a phase 1-2 trial including dose acceptability and optimality criteria, and both select an optimal dose for phase 3. The Gen 1-2-3 design has the following key differences. In stage 1, it uses phase 1-2 criteria to identify a set of candidate doses rather than 1 dose. In stage 2, which is intermediate between phase 1-2 and phase 3, it randomizes additional patients fairly among the candidate doses and an active control treatment arm and uses survival time data from both stage 1 and stage 2 patients to select an optimal dose. It then makes a Go/No Go decision of whether or not to conduct phase 3 based on the predictive probability that the selected optimal dose will provide a specified substantive improvement in survival time over the control. A simulation study shows that the Gen 1-2-3 design has desirable operating characteristics compared to the CT design and 2 conventional designs. [ABSTRACT FROM AUTHOR]
- Subjects :
- *NO-tillage
*TIME management
Subjects
Details
- Language :
- English
- ISSN :
- 0006341X
- Volume :
- 80
- Issue :
- 1
- Database :
- Academic Search Index
- Journal :
- Biometrics
- Publication Type :
- Academic Journal
- Accession number :
- 175989714
- Full Text :
- https://doi.org/10.1093/biomtc/ujad022