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Center for Global Research Data

Evaluation of available statistical methods performance under non-proportional hazards

Lead Investigator: Bharati Kumar, University of Bath
Title of Proposal Research: Evaluation of available statistical methods performance under non-proportional hazards
Vivli Data Request: 6483
Funding Source: None
Potential Conflicts of Interest: None

Summary of the Proposed Research:

The analyses of this study will help to further build an understanding of the performance of different statistical methods for analysing randomised clinical trials where the outcome is the time until some event, e.g. cancer recurrence, death. We will apply currently available statistical methods to compare their statistical properties. Based on this investigation we will be able to make recommendations about which statistical methods are most appropriate to analyse such data. This will enable analyses to give a better description of how treatment effects change over time and may also enable trials to require fewer patients, leading to cost savings and new efficacious drugs being made available to patients faster.

Requested Studies:

A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase 3 Study of Weekly Paclitaxel With or Without Ramucirumab (IMC-1121B) Drug Product in Patients With Metastatic Gastric Adenocarcinoma, Refractory to or Progressive After First-Line Therapy With Platinum and Fluoropyrimidine
Data Contributor: Lilly
Study ID: NCT01170663
Sponsor ID: 13894

Gefitinib or Carboplatin–Paclitaxel in Pulmonary Adenocarcinoma
Data Contributor: AstraZeneca
Study ID: NCT00322452
Sponsor ID: NCT00322452