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CompletedNCT03964402Updated Sep 17, 2025

Sample Size for Multivariate Time-to-event Data

An observational study in Clinical Trials, sponsored by Institut Bergonié. Completed at 1 site in France. Per ClinicalTrials.gov, last updated 2025-09-17.

Sponsored by Institut Bergonié · Observational

Study type
Observational
Model
Other
Time perspective
Other
Enrollment
500
Sex
All
01

Study 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.

02

Conditions studied

  • Clinical Trials

Keywords

  • sample size, survival, randomized clinical trials, statistical test
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In context

Lead sponsor

Institut Bergonié is the lead sponsor of 119 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Any comparative clinical trial for which modern statistical methods are required to estimate sample size, in particular, it can be clinical trials :

  • with heterogeneous populations,
  • with recurrent event data,
  • involving a biomarker-Strategy Designs With Multiple Treatments.

Eligibility criteria

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

05

Study design

Observational model
Other
Time perspective
Other
Enrollment
500 participants (actual)
Patient registry
No

Groups and cohorts

  • Clinical trial

    Corresponds to a comparative clinical trial for which our new statistical methods will be applied to estimate sample size

06

What researchers measure

Primary outcomes

  1. Overall survival

    time from randomization to death

    Time frame: 2 years

07

Study locations

1 site
  • Institut Bergonié, Comprehensive Cancer Center
    Bordeaux, 33400, France
08

References and documents

Publications

  • Dinart D, Bellera C, Rondeau V. Sample size estimation for cancer randomized trials in the presence of heterogeneous populations. Biometrics. 2022 Dec;78(4):1662-1673. doi: 10.1111/biom.13527. Epub 2021 Sep 3. PubMed 34242412 ↗
  • Dinart D, Bellera C, Rondeau V. Sample size estimation for recurrent event data using multifrailty and multilevel survival models. J Biopharm Stat. 2025 Mar;35(2):241-256. doi: 10.1080/10543406.2024.2310306. Epub 2024 Feb 9. PubMed 38334044 ↗
  • Dinart D, Rondeau V, Bellera C. Sample Size Estimation Using a Partially Clustered Frailty Model for Biomarker-Strategy Designs With Multiple Treatments. Pharm Stat. 2024 Nov-Dec;23(6):1084-1094. doi: 10.1002/pst.2407. Epub 2024 Jul 16. PubMed 39014905 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03964402
Lead sponsor
Institut Bergonié
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Responsible party
Sponsor
First posted
May 28, 2019
Start date
Jan 1, 2019
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024
Last update
Sep 17, 2025

Study contacts

Carine Bellera, PhD
principal investigator · Institut Bergonié

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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