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Centre Selection for Clinical Trials and the Generalisability of Results: A Mixed Methods Study

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  • Adrian Gheorghe
  • Tracy E Roberts
  • Jonathan C Ives
  • Benjamin R Fletcher
  • Melanie Calvert

Abstract

Background: The rationale for centre selection in randomised controlled trials (RCTs) is often unclear but may have important implications for the generalisability of trial results. The aims of this study were to evaluate the factors which currently influence centre selection in RCTs and consider how generalisability considerations inform current and optimal practice. Methods and Findings: Mixed methods approach consisting of a systematic review and meta-summary of centre selection criteria reported in RCT protocols funded by the UK National Institute of Health Research (NIHR) initiated between January 2005-January 2012; and an online survey on the topic of current and optimal centre selection, distributed to professionals in the 48 UK Clinical Trials Units and 10 NIHR Research Design Services. The survey design was informed by the systematic review and by two focus groups conducted with trialists at the Birmingham Centre for Clinical Trials. 129 trial protocols were included in the systematic review, with a total target sample size in excess of 317,000 participants. The meta-summary identified 53 unique centre selection criteria. 78 protocols (60%) provided at least one criterion for centre selection, but only 31 (24%) protocols explicitly acknowledged generalisability. This is consistent with the survey findings (n = 70), where less than a third of participants reported generalisability as a key driver of centre selection in current practice. This contrasts with trialists’ views on optimal practice, where generalisability in terms of clinical practice, population characteristics and economic results were prime considerations for 60% (n = 42), 57% (n = 40) and 46% (n = 32) of respondents, respectively. Conclusions: Centres are rarely enrolled in RCTs with an explicit view to external validity, although trialists acknowledge that incorporating generalisability in centre selection should ideally be more prominent. There is a need to operationalize ‘generalisability’ and incorporate it at the design stage of RCTs so that results are readily transferable to ‘real world’ practice.

Suggested Citation

  • Adrian Gheorghe & Tracy E Roberts & Jonathan C Ives & Benjamin R Fletcher & Melanie Calvert, 2013. "Centre Selection for Clinical Trials and the Generalisability of Results: A Mixed Methods Study," PLOS ONE, Public Library of Science, vol. 8(2), pages 1-9, February.
    • Handle: RePEc:plo:pone00:0056560
    DOI: 10.1371/journal.pone.0056560
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    References listed on IDEAS

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    1. Andrea Manca & Nigel Rice & Mark J. Sculpher & Andrew H. Briggs, 2005. "Assessing generalisability by location in trial‐based cost‐effectiveness analysis: the use of multilevel models," Health Economics, John Wiley & Sons, Ltd., vol. 14(5), pages 471-485, May.
    2. Elizabeth R. DeLong & Laura P. Coombs & T. Bruce Ferguson Jr. & Eric D. Peterson, 2005. "The Evaluation of Treatment When Center-Specific Selection Criteria Vary with Respect to Patient Risk," Biometrics, The International Biometric Society, vol. 61(4), pages 942-949, December.
    3. Kenneth F Schulz & Douglas G Altman & David Moher & for the CONSORT Group, 2010. "CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomised Trials," PLOS Medicine, Public Library of Science, vol. 7(3), pages 1-7, March.
    4. Andrea Manca & Paul C. Lambert & Mark Sculpher & Nigel Rice, 2007. "Cost-Effectiveness Analysis Using Data from Multinational Trials: The Use of Bivariate Hierarchical Modeling," Medical Decision Making, , vol. 27(4), pages 471-490, July.
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    Cited by:

    1. Raymond Oppong & Sue Jowett & Tracy E Roberts, 2015. "Economic Evaluation alongside Multinational Studies: A Systematic Review of Empirical Studies," PLOS ONE, Public Library of Science, vol. 10(6), pages 1-22, June.
    2. Arnaud Vaganay, 2016. "Cluster Sampling Bias in Government-Sponsored Evaluations: A Correlational Study of Employment and Welfare Pilots in England," PLOS ONE, Public Library of Science, vol. 11(8), pages 1-21, August.
    3. Adrian Gheorghe & Tracy Roberts & Thomas D. Pinkney & Dion G. Morton & Melanie Calvert, 2015. "Rational Centre Selection for RCTs with a Parallel Economic Evaluation—the Next Step Towards Increased Generalisability?," Health Economics, John Wiley & Sons, Ltd., vol. 24(4), pages 498-504, April.
    4. Adam Steventon & Richard Grieve & Martin Bardsley, 2015. "An Approach to Assess Generalizability in Comparative Effectiveness Research," Medical Decision Making, , vol. 35(8), pages 1023-1036, November.

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