Sample Size for Multivariate Time-to-event Data

Sponsor

Institut Bergonié (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03964402

Collaborator

Institut National de la Santé Et de la Recherche Médicale, France (Other)

200

Enrollment

Location

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Clinical Trials	Drug: intervention treatment

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2019

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Control Control arm, i.e., as per standard procedures
Experimental Experimental arm, i.e. investigational product	Drug: intervention treatment intervention treatment (any)

Arm

Intervention/Treatment

Control

Control arm, i.e., as per standard procedures

Experimental

Experimental arm, i.e. investigational product

Drug: intervention treatment

intervention treatment (any)

Outcome Measures

Primary Outcome Measures

Overall survival [2 years]
time from randomization to death

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

not applicable

Exclusion Criteria:

not applicable

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut Bergonié, Comprehensive Cancer Center	Bordeaux		France	33400

Sponsors and Collaborators

Institut Bergonié
Institut National de la Santé Et de la Recherche Médicale, France

Investigators

Principal Investigator: Carine Bellera, PhD, Institut Bergonié

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Institut Bergonié

ClinicalTrials.gov Identifier:

NCT03964402

Other Study ID Numbers:

IB2018-SAMPLE-SIZE-SURVIVAL

First Posted:

May 28, 2019

Last Update Posted:

Dec 7, 2021

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Institut Bergonié

sample size, survival, randomized clinical trials, statistical test

Study Results

No Results Posted as of Dec 7, 2021