title: Multicentre trials review process by research ethics committees in Spain: where do they stand before implementing the new European regulation?
abstract: OBJECTIVE
  To review the performance of research ethics committees (RECs) in Spain in assessing multicentre clinical trial (MCT) drug protocols, and to evaluate if they would comply with the requirements of the new EU Directive to be implemented by May 2004.
  
  
  METHODS
  Prospective study of applications of MCT submitted to RECs.
  
  
  METHODS
  Protocol related features and evaluation process dynamics.
  
  
  RESULTS
  187 applications (24 protocols, 18 study drugs) to be performed in 114 centres, were reviewed by 62 RECs. RECs had a median number of 14 members, of which three were lay members. All applications were approved except four which were however approved by the other RECs involved. The median times from submission to approval and from submission to reception at the sponsor's offices were 48 and 62 days, respectively. In 55% (101/183) of all applications approved, 41 RECs raised 307 queries, 40% of these were protocol related issues, and 38% related to the patients' information sheets. RECs charging an evaluation fee in advance and applications with no queries raised were statistically significantly associated with shorter evaluation times. However, there is a gap of at least 1.5 weeks between the date of the meeting and the reception of the approval letter in the sponsor's office.
  
  
  CONCLUSIONS
  Evaluating MCT protocols by RECs is a time consuming process. Needing 1.5 weeks for communicating the decision taken by RECs to the sponsor suggests serious administrative shortcomings within most RECs. By significantly reducing the time for communication of their decisions, the majority of RECs would comply with the Directive requirement of a maximum 60 day period for the assessment of MCT.
authors.affiliation: Medical Department, GlaxoSmithKline, Parque Tecnológico de Madrid, C/ Severo Ochoa, 2, 28760 Tres Cantos, Madrid, Spain. rafael.dal-re@gsk.com
authors.forename: R
authors.initials: R
authors.lastname: Dal-Ré
authors.forename: R
authors.initials: R
authors.lastname: Ortega
authors.forename: E
authors.initials: E
authors.lastname: Morejón
mesh_terms: D002985:Clinical Protocols; D002986:Clinical Trials as Topic / Q000592:standards*; D028744:Ethics Committees, Research / Q000331:legislation & jurisprudence / Q000592:standards*; D005062:European Union; D005260:Female; D006801:Humans; D008297:Male; D015337:Multicenter Studies as Topic / Q000592:standards*; D017712:Peer Review, Research / Q000941:ethics / Q000379:methods; D013030:Spain; D013997:Time Factors