IS GOOD CLINICAL RESEARCH PRACTICE FOR CLINICAL-TRIALS GOOD CLINICAL-PRACTICE

This article presents results of monitoring of the recruitment process for a phase III study of a new antidepressant drug in elderly patient s with depressive disorders, focusing on the peculiarities of recruitm ent posed by the presence of comorbidity and coadministration of medic ations. Data are derived from screening of 188 patients, the majority of whom lived at home, referred for trial inclusion. One hundred and s eventy-one (91%) had Hamilton Rating Scale score in excess of 18 and m et inclusion criteria. Only eight (4.2%) elderly depressed subjects co uld be recruited, after application of exclusion criteria. The trial d ata so obtained may be scientifically credible, but the conclusions re ached by trials with very stringent exclusion criteria do not reflect the practice environment in which the product will be prescribed by cl inicians. This raises questions of the relevance of good clinical rese arch practice and good clinical practice guidelines to the reality of good clinical practice beyond the trial situation.