title: [Evaluation of clinical research studies in a comprehensive cancer center].
abstract: OBJECTIVE
  The number of clinical trials in cancer patients has experienced an important growth during last years. However, it is difficult to find data showing this activity in Spanish Hospitals. This study analyses the clinical trials data bases between 1996 and 2002 in a cancer center.
  
  
  METHODS
  We perform a descriptive analysis of data from: selection of protocols, origin of proposals, sponsors, investigators, studies performed and published; demographic data about patients and phase of the studies in which they have been included.
  
  
  RESULTS
  Evaluation was undertaken with a standardised protocol review assessment. 337 proposals of clinical trials were evaluated during 1996-2002, with a decreasing acceptance index (62.5% to 39.18%, respectively), the number of proposals has grown from 16 in 1996 to 74 in 2002. The general recruitment index was 6.64%. Between 1995-2002, 1479 patients were registered; only 5% were older than 75 years. Pharmaceutical Companies sponsored the majority of the studies, although Co-operative Groups promote an important number of studies, especially in Haematology and Radiotherapy. Thirteen studies performed between 1996-1998 had been published, and 3 more are accepted for publication (69.5%).
  
  
  CONCLUSIONS
  The number of patients included in clinical trials is limited and older patients are not well represented in them.
authors.affiliation: Instituto Catalán de Oncología, Hospital Duran i Reynals, L'Hospitalet de Llobregat, Barcelona, España. mgarciamartin@csub.scs.es
authors.forename: Margarita
authors.initials: M
authors.lastname: García
authors.forename: Josep Ramon Germà
authors.initials: JR
authors.lastname: Lluch
authors.forename: Carles
authors.initials: C
authors.lastname: Serra
authors.forename: Xavier
authors.initials: X
authors.lastname: Pérez
authors.forename: Gema
authors.initials: G
authors.lastname: Berenguer
authors.forename: Josep Maria
authors.initials: JM
authors.lastname: Borràs
mesh_terms: D035843:Biomedical Research / Q000706:statistics & numerical data*; D002173:Cancer Care Facilities; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D013030:Spain