Clinical Study Data Request
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Proposal 1707

Title of the Proposed Research

Comparative Effectiveness Analysis with Data From Randomized Clinical Trials and Observational Studies

Lead Researcher

Herbert Pang


The University of Hong Kong
Duke University (Adjunct)

Funding Source


Potential Conflicts of Interest

Stock or Other Ownership: McKesson
Consulting or Advisory Role: Eli Lilly

Data Sharing Agreement Date

15 March 2017

Lay Summary

From our recently completed NIH R21 project, we have assembled data from existing phase II/III trials for non-small cell and small cell lung cancer from six national cancer cooperative groups (Pang et al. 2016). The goal of this research is to perform pooled analyses of clinical studies and observational studies to evaluate systematically the benefits and risks of treating elderly lung cancer patients with radiation and chemotherapy. Clinical studies will come from cancer cooperative groups and industry.

Using the data assembled from multi-center clinical trials and populated-based cohorts from Asia and North America, we will assess the relative treatment effect of concurrent chemotherapy and radiation therapy (Cx/RT) and sequential Cx/RT in elderly lung cancer patients. Equipped with new statistical methods for the aggregated data from multiple sources, we expect the research project will increase our understanding about how to treat elderly lung cancer patients. More generally, the project aims to establish the separate-and-combined approach as a general framework to estimate treatment effect when data are aggregated from both randomized clinical trials and observational studies. The approach is applicable to a broad array of disease areas where comparative effectiveness of multiple treatment regimens are of interest. The results of this project will aid the design and implementation of future elderly-specific trials.

Study Data Provided

LILLY-H3E-MC-JMIG: Phase 3 Study of Pemetrexed, Cisplatin, and Radiotherapy Followed by Consolidation Pemetrexed versus Etoposide, Cisplatin, and Radiotherapy Followed by Consolidation Cytotoxic Chemotherapy of Choice in Patients with Unresectable, Locally Advanced, Stage III Non-Small Cell Lung Cancer Other than Predominantly Squamous Cell Histology

Statistical Analysis Plan

Publication Citation

The publication citation will be added after the research is published.

Summary Results

Results summary or link will be posted when available.