Sample Size for Multivariate Time-to-event Data

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03964402

Enrollment

500

Registered

2019-05-28

Start date

2019-01-01

Completion date

2024-12-31

Last updated

2025-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clinical Trials

Keywords

sample size, survival, randomized clinical trials, statistical test

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

Any comparative clinical trial for which modern statistical methods are required to estimate sample size

Design outcomes

Primary

Measure	Time frame	Description
Overall survival	2 years	time from randomization to death

Countries

France

Outcome results