title: Clinical trial metadata: defining and extracting metadata on the design, conduct, results and costs of 125 randomised clinical trials funded by the National Institute for Health Research Health Technology Assessment programme.
abstract: BACKGROUND
  By 2011, the Health Technology Assessment (HTA) programme had published the results of over 100 trials with another 220 in progress. The aim of the project was to develop and pilot 'metadata' on clinical trials funded by the HTA programme.
  
  
  OBJECTIVE
  The aim of the project was to develop and pilot questions describing clinical trials funded by the HTA programme in terms of it meeting the needs of the NHS with scientifically robust studies. The objectives were to develop relevant classification systems and definitions for use in answering relevant questions and to assess their utility.
  
  
  METHODS
  Published monographs and internal HTA documents.
  
  
  METHODS
  A database was developed, 'populated' using retrospective data and used to answer questions under six prespecified themes. Questions were screened for feasibility in terms of data availability and/or ease of extraction. Answers were assessed by the authors in terms of completeness, success of the classification system used and resources required. Each question was scored to be retained, amended or dropped.
  
  
  RESULTS
  One hundred and twenty-five randomised trials were included in the database from 109 monographs. Neither the International Standard Randomised Controlled Trial Number nor the term 'randomised trial' in the title proved a reliable way of identifying randomised trials. Only limited data were available on how the trials aimed to meet the needs of the NHS. Most trials were shown to follow their protocols but updates were often necessary as hardly any trials recruited as planned. Details were often lacking on planned statistical analyses, but we did not have access to the relevant statistical plans. Almost all the trials reported on cost-effectiveness, often in terms of both the primary outcome and quality-adjusted life-years. The cost of trials was shown to depend on the number of centres and the duration of the trial. Of the 78 questions explored, 61 were well answered, 33 fully with 28 requiring amendment were the analysis updated. The other 17 could not be answered with readily available data.
  
  
  CONCLUSIONS
  The study was limited by being confined to 125 randomised trials by one funder.
  
  
  CONCLUSIONS
  Metadata on randomised controlled trials can be expanded to include aspects of design, performance, results and costs. The HTA programme should continue and extend the work reported here.
  
  
  BACKGROUND
  The National Institute for Health Research HTA programme.
authors: Wessex Institute, Faculty of Medicine, University of Southampton, Southampton, UK.
authors: James
authors: J
authors: Raftery
authors: Wessex Institute, Faculty of Medicine, University of Southampton, Southampton, UK.
authors: Amanda
authors: A
authors: Young
authors: University of Southampton Clinical Trials Unit, Southampton General Hospital, Southampton, UK.
authors: Louise
authors: L
authors: Stanton
authors: Wessex Institute, Faculty of Medicine, University of Southampton, Southampton, UK.
authors: Ruairidh
authors: R
authors: Milne
authors: Wessex Institute, Faculty of Medicine, University of Southampton, Southampton, UK.
authors: Andrew
authors: A
authors: Cook
authors: Wessex Institute, Faculty of Medicine, University of Southampton, Southampton, UK.
authors: David
authors: D
authors: Turner
authors: Wessex Institute, Faculty of Medicine, University of Southampton, Southampton, UK.
authors: Peter
authors: P
authors: Davidson
mesh_terms: D003362:Cost-Benefit Analysis / Q000379:methods / Q000592:standards*; D000068598:Data Accuracy; D003627:Data Interpretation, Statistical; D016208:Databases, Factual; D005380:Financing, Government; D006801:Humans; D017063:Outcome Assessment, Health Care / Q000191:economics / Q000592:standards / Q000706:statistics & numerical data*; D010865:Pilot Projects; D016032:Randomized Controlled Trials as Topic / Q000191:economics / Q000379:methods / Q000592:standards*; D012109:Research Support as Topic / Q000191:economics / Q000379:methods / Q000592:standards; D013222:State Medicine / Q000191:economics / Q000592:standards*; D013673:Technology Assessment, Biomedical / Q000191:economics / Q000379:methods / Q000592:standards*; D006113:United Kingdom