The need for increased harmonisation of clinical trials and economic evaluations

Research output: Contribution to journalArticle


Colleges, School and Institutes

External organisations

  • London School of Hygiene and Tropical Medicine
  • Department of Global Health and Development
  • Health Economics Unit, School of Health and Population Sciences, Public Health Building, University of Birmingham, Birmingham, B15 2TT.


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