Ignite Creation Date:
2024-05-06 @ 1:13 PM
Last Modification Date:
2024-10-26 @ 1:10 PM
Study NCT ID:
NCT03964402
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-02-21
First Post:
2019-05-23
Brief Title:
Sample Size for Multivariate Time-to-event Data
Sponsor:
Institut Bergonié
Organization:
Institut Bergonié
Study Overview
Official Title:
Sample Size Determination in Heterogeneous Populations for Multivariate Time-to-event Data
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Most of randomized clinical trials RCT using time-to-event criteria as the primary endpoint are designed powered and analyzed based on an hypothetical hazard ratio HR corresponding to the targeted effect size between experimental and control arms Usually one assumes that populations are homogeneous within each treatment arm that is within each arm i the baseline risk is identical for all patients and ii the treatment effect is identical for all patients This assumption however may not hold in all circumstances This project aims at providing a statistical method for the estimation of sample size in RCT in the presence of heterogenous populations such as assuming populations with distinct underlying baseline risks or assuming different treatment effects
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None