TAMOXIFEN COMPLIANCE IN A CLINICAL-TRIAL

Citation
Ja. Dewar et al., TAMOXIFEN COMPLIANCE IN A CLINICAL-TRIAL, Breast, 5(3), 1996, pp. 152-153
Citations number
6
Categorie Soggetti
Oncology,"Obsetric & Gynecology
Journal title
BreastACNP
ISSN journal
09609776
Volume
5
Issue
3
Year of publication
1996
Pages
152 - 153
Database
ISI
SICI code
0960-9776(1996)5:3<152:TCIAC>2.0.ZU;2-6
Abstract
In the Scottish Adjuvant Tamoxifen Trial, patients with operable breas t cancer were randomized to adjuvant tamoxifen or to tamoxifen at firs t recurrence. Sixty-six Tayside patients from this trial were still al ive on 1 January 1993, and still living in Tayside. The Medicines Moni toring Unit (MEMO) collects all prescriptions redeemed by patients in Tayside. From trial records, it was determined whether patients should be taking tamoxifen or not, and this was checked against the dispense d prescription data from MEMO for 6 months from 1 January 1993. Twenty -three were correctly confirmed as receiving prescriptions for tamoxif en and 43 confirmed as not. Known changes to tamoxifen prescribing wer e reflected in the pattern and timing of the prescriptions. Prescripti on monitoring has confirmed that all patients were redeeming their pre scriptions for tamoxifen in this trial of adjuvant tamoxifen. This wou ld tend to support validity of the trial results as well as data on ad verse events. It can be used as a method of quality assurance in clini cal trials and to correlate adverse events with prescribing history.