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Register3+3 Design [Design Issues]
Hello All,
This is regarding 3+3 design for Phase-I trial. I have searched online and found some articles on design. My Question is that once the group/cohort is completed with 3 patients, whether same patients will be enrolled in next cohort or new patient will be enrolled? Further, in next cohort suppose 1 patient is withdarwn or have some AE then its compulsory to add 3 more patients to inline with multiplication of 3?
Thanks,
Pharma_88
This is regarding 3+3 design for Phase-I trial. I have searched online and found some articles on design. My Question is that once the group/cohort is completed with 3 patients, whether same patients will be enrolled in next cohort or new patient will be enrolled? Further, in next cohort suppose 1 patient is withdarwn or have some AE then its compulsory to add 3 more patients to inline with multiplication of 3?
Thanks,
Pharma_88
Complete thread:
- 3+3 DesignPharma_88 2020-01-07 08:09 [Design Issues]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 3+3 Design Ohlbe 2020-01-07 11:25
- 3+3 Design Pharma_88 2020-01-08 09:55
- Subject replacement Ohlbe 2020-01-08 10:41
- 3+3 Design Pharma_88 2020-01-08 09:55
- Dose escalation and DMC Helmut 2020-01-07 12:18
- Dose escalation and DMC Pharma_88 2020-01-08 09:56
- 3+3 Design Ohlbe 2020-01-07 11:25
Ing. Helmut Schütz