A note on the probability structure of a doubly randomized delayed start design
The innovative doubly randomized delayed start (DRDS) design has been implemented to tackle the well-known challenge of a high placebo response rate in clinical trials. This design begins with a conventional parallel design phase (period 1), followed by a subsequent phase (period 2) where subjects i...
Saved in:
| Main Author: | |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Taylor & Francis Group
2025-01-01
|
| Series: | Statistical Theory and Related Fields |
| Subjects: | |
| Online Access: | https://www.tandfonline.com/doi/10.1080/24754269.2025.2457279 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1832575667516997632 |
|---|---|
| author | Zhao Yang |
| author_facet | Zhao Yang |
| author_sort | Zhao Yang |
| collection | DOAJ |
| description | The innovative doubly randomized delayed start (DRDS) design has been implemented to tackle the well-known challenge of a high placebo response rate in clinical trials. This design begins with a conventional parallel design phase (period 1), followed by a subsequent phase (period 2) where subjects initially assigned to placebo and who did not respond are re-randomized to either the test drug or placebo. Chi, G. Y., Li, Y., Liu, Y., Lewin, D., & Lim, P. (2016 On clinical trials with a high placebo response rate. Contemporary Clinical Trials Communications, 2, 34–53. https://doi.org/10.1016/j.conctc.2015.10.002) introduced a new statistical methodology with a conditional probability structure to account for the specific characteristics of the DRDS design. However, some critical formulas in Chi et al. (2016, p. 38) for this probability structure are incorrect. Here, we correct these formulas and provide a comprehensive technical background on deriving the probability structure for a DRDS design to support these corrections. |
| format | Article |
| id | doaj-art-895b96b6f4144e03aefbcebb68826be1 |
| institution | Kabale University |
| issn | 2475-4269 2475-4277 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Statistical Theory and Related Fields |
| spelling | doaj-art-895b96b6f4144e03aefbcebb68826be12025-01-31T18:29:50ZengTaylor & Francis GroupStatistical Theory and Related Fields2475-42692475-42772025-01-011610.1080/24754269.2025.2457279A note on the probability structure of a doubly randomized delayed start designZhao Yang0Keros Therapeutics Inc., Lexington, MA, USAThe innovative doubly randomized delayed start (DRDS) design has been implemented to tackle the well-known challenge of a high placebo response rate in clinical trials. This design begins with a conventional parallel design phase (period 1), followed by a subsequent phase (period 2) where subjects initially assigned to placebo and who did not respond are re-randomized to either the test drug or placebo. Chi, G. Y., Li, Y., Liu, Y., Lewin, D., & Lim, P. (2016 On clinical trials with a high placebo response rate. Contemporary Clinical Trials Communications, 2, 34–53. https://doi.org/10.1016/j.conctc.2015.10.002) introduced a new statistical methodology with a conditional probability structure to account for the specific characteristics of the DRDS design. However, some critical formulas in Chi et al. (2016, p. 38) for this probability structure are incorrect. Here, we correct these formulas and provide a comprehensive technical background on deriving the probability structure for a DRDS design to support these corrections.https://www.tandfonline.com/doi/10.1080/24754269.2025.2457279Doubly randomized delayed startsequential parallel comparison designplacebo effecttruncation |
| spellingShingle | Zhao Yang A note on the probability structure of a doubly randomized delayed start design Statistical Theory and Related Fields Doubly randomized delayed start sequential parallel comparison design placebo effect truncation |
| title | A note on the probability structure of a doubly randomized delayed start design |
| title_full | A note on the probability structure of a doubly randomized delayed start design |
| title_fullStr | A note on the probability structure of a doubly randomized delayed start design |
| title_full_unstemmed | A note on the probability structure of a doubly randomized delayed start design |
| title_short | A note on the probability structure of a doubly randomized delayed start design |
| title_sort | note on the probability structure of a doubly randomized delayed start design |
| topic | Doubly randomized delayed start sequential parallel comparison design placebo effect truncation |
| url | https://www.tandfonline.com/doi/10.1080/24754269.2025.2457279 |
| work_keys_str_mv | AT zhaoyang anoteontheprobabilitystructureofadoublyrandomizeddelayedstartdesign AT zhaoyang noteontheprobabilitystructureofadoublyrandomizeddelayedstartdesign |