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Sample Size for Multivariate Time-to-event Data

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03964402
Recruitment Status : Active, not recruiting
First Posted : May 28, 2019
Last Update Posted : May 28, 2019
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Clinical Trials Drug: intervention treatment

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Study Type : Observational
Estimated 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 : January 1, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

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




Primary Outcome Measures :
  1. Overall survival [ Time Frame: 2 years ]
    time from randomization to death



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
to be adapted to the indication under investigation
Criteria

Inclusion Criteria:

  • not applicable

Exclusion Criteria:

  • not applicable

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03964402


Locations
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France
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
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Principal Investigator: Carine Bellera, PhD Institut Bergonié
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Responsible Party: Institut Bergonié
ClinicalTrials.gov Identifier: NCT03964402    
Other Study ID Numbers: IB2018-SAMPLE-SIZE-SURVIVAL
First Posted: May 28, 2019    Key Record Dates
Last Update Posted: May 28, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut Bergonié:
sample size, survival, randomized clinical trials, statistical test