title: Practice and policy of measuring quality of life and health economics in cancer clinical trials: a survey among co-operative trial groups.
abstract: BACKGROUND
  Co-operative groups have played an important role in the advance of health-related quality of life (HRQL) research. However, definitions of the concept, criteria for selection of existing instruments and methods for data collection and interpretation remain poorly defined in the literature. A survey was conducted amongst the major cancer co-operative groups in order to gain a better understanding of their current policy and processes to ensure optimal HRQL data collection within cancer clinical trials. The topic of health economics was similarly addressed.
  
  
  METHODS
  A written questionnaire was addressed to 16 major European and North American cancer co-operative groups. Eleven groups responded (response rate: 69%). however, one group could not provide information for the survey, thus ten questionnaires were available for analysis.
  
  
  RESULTS
  The results from this survey among co-operative groups show that HRQL (more than health economics) is recognized as an important, although usually secondary, outcome measure in oncology trials. On the whole, co-operative groups have a rather flexible policy towards the inclusion of HRQL (and HE) into their clinical trials, and practice is very much on a case-by-case basis, but use standard practice guidelines and internal procedures is to ensure well-defined study protocols and enhance good quality studies.
authors.affiliation: MEDTAP International, London, UK. kiebert@medtap.co.uk
authors.forename: G
authors.initials: G
authors.lastname: Kiebert
authors.forename: S
authors.initials: S
authors.lastname: Wait
authors.forename: J
authors.initials: J
authors.lastname: Bernhard
authors.forename: A
authors.initials: A
authors.lastname: Bezjak
authors.forename: D
authors.initials: D
authors.lastname: Cella
authors.forename: R
authors.initials: R
authors.lastname: Day
authors.forename: J
authors.initials: J
authors.lastname: Houghton
authors.forename: C
authors.initials: C
authors.lastname: Moinpour
authors.forename: C
authors.initials: C
authors.lastname: Scott
authors.forename: R
authors.initials: R
authors.lastname: Stephens
mesh_terms: D001290:Attitude; D003625:Data Collection; D003659:Decision Making, Organizational; D006801:Humans; D007391:International Cooperation; D009369:Neoplasms / Q000191:economics / Q000523:psychology*; D016134:Organizational Policy; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic / Q000379:methods* / Q000706:statistics & numerical data; D011795:Surveys and Questionnaires; D016896:Treatment Outcome