title: Exclusion of older people from clinical trials: professional views from nine European countries participating in the PREDICT study.
abstract: BACKGROUND
  There has been concern about under-representation of older people in clinical trials. The PREDICT study reported that older people and those with co-morbidity continue to be excluded unjustifiably from clinical trials. However, there is no information about differences of opinion on these issues between EU countries. The results of a survey of health-related professionals from nine EU countries that participated in the PREDICT study are presented in this study.
  
  
  OBJECTIVE
  The aim of the study was to identify and examine any differences of opinion between EU countries on the inclusion of older patients in clinical trials.
  
  
  METHODS
  A questionnaire using a Likert scale and free text was completed by 521 general practitioners, geriatricians, clinical researchers, ethicists, nurses and industry pharmacologists/pharmacists. The questions explored the impact of the present situation, possible reasons for under-representation and potential methods of improving participation. Countries participating were the Czech Republic, Israel, Italy, Lithuania, the Netherlands, Poland, Romania, Spain and the UK.
  
  
  RESULTS
  There was agreement that exclusion from clinical trials on age grounds alone was unjustified (87%) and that under-representation of older people in trials caused difficulties for prescribers (79%) and patients (73%). There were national differences between professionals. All but the Lithuanians believed that older people were disadvantaged because of under-representation. The Czech, Lithuanian and Romanian professionals felt that it was justified to have age limits based on co-morbidity (61-83%) and polypharmacy (63-85%). Romanians also thought that having age limits on trial participation was justified because of reduced life expectancy (62%) and physical disability (58%) in older people. All but the Romanian professionals felt that the present arrangements for clinical trials were satisfactory (62%). All but the Israelis (56%) and Lithuanians (70%) agreed that regulation of clinical trials needed alteration.
  
  
  CONCLUSIONS
  Although respondent selection bias cannot be excluded, the differences that emerged between countries may be the result of the political and healthcare-system differences between older and newer members of the EU. These differences may influence decision making about clinical trial regulations and practice in older people.
authors.affiliation: Institute for Life Course Studies, Keele University, Staffordshire, UK. p.crome@med.keele.ac.uk
authors.forename: Peter
authors.initials: P
authors.lastname: Crome
authors.forename: Frank
authors.initials: F
authors.lastname: Lally
authors.forename: Antonio
authors.initials: A
authors.lastname: Cherubini
authors.forename: Joaquim
authors.initials: J
authors.lastname: Oristrell
authors.forename: Andrew D
authors.initials: AD
authors.lastname: Beswick
authors.forename: A Mark
authors.initials: AM
authors.lastname: Clarfield
authors.forename: Cees
authors.initials: C
authors.lastname: Hertogh
authors.forename: Vita
authors.initials: V
authors.lastname: Lesauskaite
authors.forename: Gabriel I
authors.initials: GI
authors.lastname: Prada
authors.forename: Katarzyna
authors.initials: K
authors.lastname: Szczerbińska
authors.forename: Eva
authors.initials: E
authors.lastname: Topinkova
authors.forename: Judith
authors.initials: J
authors.lastname: Sinclair-Cohen
authors.forename: David
authors.initials: D
authors.lastname: Edbrooke
authors.forename: Gary
authors.initials: G
authors.lastname: Mills
mesh_terms: D000367:Age Factors; D000368:Aged; D002986:Clinical Trials as Topic / Q000191:economics / Q000331:legislation & jurisprudence / Q000379:methods* / Q000706:statistics & numerical data*; D015897:Comorbidity; D015340:Epidemiologic Research Design; D005060:Europe; D005104:Expert Testimony; D006801:Humans; D018579:Patient Selection / Q000941:ethics; D010820:Physicians; D011795:Surveys and Questionnaires