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Open Access 01-07-2016 | Correspondence article

Best practice for analysis of shared clinical trial data

Authors: Sally Hollis, Christine Fletcher, Frances Lynn, Hans-Joerg Urban, Janice Branson, Hans-Ulrich Burger, Catrin Tudur Smith, Matthew R. Sydes, Christoph Gerlinger

Published in: BMC Medical Research Methodology | Special Issue 1/2016

Abstract

Background

Greater transparency, including sharing of patient-level data for further research, is an increasingly important topic for organisations who sponsor, fund and conduct clinical trials. This is a major paradigm shift with the aim of maximising the value of patient-level data from clinical trials for the benefit of future patients and society. We consider the analysis of shared clinical trial data in three broad categories: (1) reanalysis - further investigation of the efficacy and safety of the randomized intervention, (2) meta-analysis, and (3) supplemental analysis for a research question that is not directly assessing the randomized intervention.

Discussion

In order to support appropriate interpretation and limit the risk of misleading findings, analysis of shared clinical trial data should have a pre-specified analysis plan. However, it is not generally possible to limit bias and control multiplicity to the extent that is possible in the original trial design, conduct and analysis, and this should be acknowledged and taken into account when interpreting results. We highlight a number of areas where specific considerations arise in planning, conducting, interpreting and reporting analyses of shared clinical trial data. A key issue is that that these analyses essentially share many of the limitations of any post hoc analyses beyond the original specified analyses. The use of individual patient data in meta-analysis can provide increased precision and reduce bias. Supplemental analyses are subject to many of the same issues that arise in broader epidemiological analyses. Specific discussion topics are addressed within each of these areas.

Summary

Increased provision of patient-level data from industry and academic-led clinical trials for secondary research can benefit future patients and society. Responsible data sharing, including transparency of the research objectives, analysis plans and of the results will support appropriate interpretation and help to address the risk of misleading results and avoid unfounded health scares.

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Title: Best practice for analysis of shared clinical trial data
Authors: Sally Hollis
Christine Fletcher
Frances Lynn
Hans-Joerg Urban
Janice Branson
Hans-Ulrich Burger
Catrin Tudur Smith
Matthew R. Sydes
Christoph Gerlinger
Publication date: 01-07-2016
Publisher: BioMed Central
Published in: BMC Medical Research Methodology / Issue Special Issue 1/2016
Electronic ISSN: 1471-2288
DOI: https://doi.org/10.1186/s12874-016-0170-y

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Best practice for analysis of shared clinical trial data

Abstract

Background

Discussion

Summary

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Abstract

Background

Discussion

Summary

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