[Evaluation of clinical research studies in a comprehensive cancer center]

Abstract

Background and 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.

Material and 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.