The need for increased harmonisation of clinical trials and economic evaluations

Adrian Gheorghe, Derek Kyte, Melanie Calvert*, Derek Kyte

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

1 Citation (Scopus)


Despite the increasing number of protocol and reporting guidelines available to trialists, there is still little guidance for protocol writers on the incorporation of patient-reported outcomes and economic assessments alongside clinical trials. It is unsurprising, therefore, that trial protocols present disproportionately less information for the economic evaluation component than for clinical outcomes. Costing methodologies, generalisability considerations, methods to address sensitive patient-reported outcome information and missing data are often insufficiently described in the trial protocol. The paper illustrates these shortcomings with specific examples and makes a case for shifting researchers' attention from the reporting to the design stage of trial-based economic evaluation to promote the validity, generalisability and accountability of trial-based economic evaluations.

Original languageEnglish
Pages (from-to)171-173
Number of pages3
JournalExpert Review of Pharmacoeconomics & Outcomes Research
Issue number2
Publication statusPublished - 2014


  • Clinical trials
  • Economic evaluation
  • Generalisability
  • Patient-reported outcomes
  • Protocol
  • Study design

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Health Policy
  • Medicine(all)


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