Trials

, 16:P43 | Cite as

What are the methodological designs of nihr funded clinical trials? Going beyond routine data collection

  • Amanda Young
  • Helen Buxton
  • Liz Tremain
  • Tom Kenny
Poster presentation
  • 242 Downloads

Keywords

Clinical Trial Primary Outcome Active Status Data Field Final Report 

Background

In 2015, a report was published in the Health Technology Assessment which piloted the use of extracting metadata on the design, conduct, results and costs of clinical trials funded by the Health Technology Assessment programme. A recommendation was to explore the feasibility of extracting data on the active NIHR portfolio of clinical trials.

Aims and objectives

To develop and pilot a method to capture data on the design and methodology of all active NIHR funded clinical trials.

Method

We will review the NIHR portfolio of clinical trials that have an active status (from pre-contracting status to submission of final report) from data extracted in November 2014. The first part of the pilot will extract data on the design and methodological features of a clinical trial, using the existing data fields from the metadata database published in the 2015 HTA report.

Results

The key findings will include an overview of the type of clinical trials funded by NIHR and whether there are differences between the NIHR Programmes. Particular attention will be paid to key methodological elements such as the design framework, number of arms and primary outcomes and the type of interventions.

Conclusions

Examining the methodological design of NIHR clinical trials is important to maximise the added value of metadata approaches beyond routine data collection and for increasing awareness of the type of trials funded by NIHR.

Copyright information

© Young et al. 2015

This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

Authors and Affiliations

  • Amanda Young
    • 1
  • Helen Buxton
    • 1
  • Liz Tremain
    • 1
  • Tom Kenny
    • 1
  1. 1.National Institute for Health Research, EvaluationTrials and Studies Coordinating CentreSouthamptonUK

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