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Summarising salient information on historical controls: A structured assessment of validity and comparability across studies

Hatswell, A; Freemantle, N; Baio, G; Lesaffre, E; van Rosmalen, J; (2020) Summarising salient information on historical controls: A structured assessment of validity and comparability across studies. Clinical Trials 10.1177/1740774520944855. (In press). Green open access

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Abstract

BACKGROUND: While placebo-controlled randomised controlled trials remain the standard way to evaluate drugs for efficacy, historical data are used extensively across the development cycle. This ranges from supplementing contemporary data to increase the power of trials to cross-trial comparisons in estimating comparative efficacy. In many cases, these approaches are performed without in-depth review of the context of data, which may lead to bias and incorrect conclusions. METHODS: We discuss the original 'Pocock' criteria for the use of historical data and how the use of historical data has evolved over time. Based on these factors and personal experience, we created a series of questions that may be asked of historical data, prior to their use. Based on the answers to these questions, various statistical approaches are recommended. The strategy is illustrated with a case study in colorectal cancer. RESULTS: A number of areas need to be considered with historical data, which we split into three categories: outcome measurement, study/patient characteristics (including setting and inclusion/exclusion criteria), and disease process/intervention effects. Each of these areas may introduce issues if not appropriately handled, while some may preclude the use of historical data entirely. We present a tool (in the form of a table) for highlighting any such issues. Application of the tool to a colorectal cancer data set demonstrates under what conditions historical data could be used and what the limitations of such an analysis would be. CONCLUSION: Historical data can be a powerful tool to augment or compare with contemporary trial data, though caution is required. We present some of the issues that may be considered when involving historical data and what (if any) statistical approaches may account for differences between studies. We recommend that, where historical data are to be used in analyses, potential differences between studies are addressed explicitly.

Type: Article
Title: Summarising salient information on historical controls: A structured assessment of validity and comparability across studies
Location: England
Open access status: An open access version is available from UCL Discovery
DOI: 10.1177/1740774520944855
Publisher version: https://doi.org/10.1177%2F1740774520944855
Language: English
Additional information: © 2020 by The Society for Clinical Trials.This article is distributed under the terms of the Creative Commons Attribution 4.0 License (http://creativecommons.org/licenses/by/4.0/).
Keywords: Historical control, matching-adjusted indirect comparison, power prior, propensity scoring
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology > Comprehensive CTU at UCL
UCL > Provost and Vice Provost Offices > UCL BEAMS
UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Maths and Physical Sciences
UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Maths and Physical Sciences > Dept of Statistical Science
URI: https://discovery.ucl.ac.uk/id/eprint/10111378
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