Sample Size for Multivariate Time-to-event Data

Active, not recruiting

• Conditions: Clinical Trials
• Interventions: Drug: intervention treatment

• Registration Number: NCT03964402
• Lead Sponsor: Institut Bergonié

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

Not available

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2019-05-23
• Study First Submitted QC: 2019-05-23
• Study First Posted: 2019-05-28
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-20
• Last Update Posted: 2023-02-21
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• not applicable

Exclusion Criteria

• not applicable

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental	intervention treatment	Experimental arm, i.e. investigational product

Primary Outcome Measures

Name	Time	Method
Overall survival	2 years	time from randomization to death

Trial Locations

Locations (1)

Institut Bergonié, Comprehensive Cancer Center; 🇫🇷 Bordeaux, France