Sample Size for Multivariate Time-to-event Data

Clinical Trials Clinical Trial

Official title:

Sample Size Determination in Heterogeneous Populations for Multivariate Time-to-event Data

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03964402
• Other study ID #: IB2018-SAMPLE-SIZE-SURVIVAL
• Status: Active, not recruiting
• Start date: January 1, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2023
• Source: Institut Bergonié
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• not applicable

Exclusion Criteria:

• not applicable

Related Conditions & MeSH terms

• Clinical Trials

Intervention

Drug:
• intervention treatment
intervention treatment (any)

Locations

Country	Name	City	State
France	Institut Bergonié, Comprehensive Cancer Center	Bordeaux

Sponsors (2)

Lead Sponsor	Collaborator
Institut Bergonié	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	time from randomization to death	2 years