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 patients with depressive disorders, focusing on the peculiarities of recruitment posed by the presence of comorbidity and coadministration of medications. Data are derived from screening of 188 patients, the majority of whom lived at home, referred for trial inclusion. One hundred and seventy-one (91%) had Hamilton Rating Scale score in excess of 18 and met inclusion criteria. Only eight (4.2%) elderly depressed subjects could be recruited, after application of exclusion criteria. The trial data so obtained may be scientifically credible, but the conclusions reached by trials with very stringent exclusion criteria do not reflect the practice environment in which the product will be prescribed by clinicians. This raises questions of the relevance of good clinical research practice and good clinical practice guidelines to the reality of good clinical practice beyond the trial situation.
Yastrubetskaya
O
O
Academic Unit for Psychiatry of Old Age, University of Melbourne, Kew, Australia.
Chiu
E
E
O'Connell
S
S
D000368:Aged; D000928:Antidepressive Agents / Q000009:adverse effects / Q000627:therapeutic use; D017326:Clinical Trials, Phase III as Topic / Q000706:statistics & numerical data*; D003866:Depressive Disorder / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data*; D015203:Reproducibility of Results; D012107:Research Design
D000928:Antidepressive Agents