Tamoxifen compliance in a clinical trial
Tamoxifen compliance in a clinical trial
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DOI：
10.1016/s0960-9776(96)90060-0
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发表时间：
1996-06-01
期刊：
影响因子：
3.9
通讯作者：
MacDonald, TM
中科院分区：
文献类型：
--
作者：
Dewar, JA;Stewart, HJ;MacDonald, TM
在苏格兰辅助他莫昔芬试验中，可手术乳腺癌患者被随机分配接受他莫昔芬辅助治疗或首次复发时接受他莫昔芬治疗。 1993 年 1 月 1 日，本次试验中的 66 名泰赛德患者仍然活着，并且仍然居住在泰赛德。药品监控单元 (MEMO) 收集泰赛德患者兑换的所有处方。根据试验记录，确定患者是否应该服用他莫昔芬，并与 MEMO 中自 1993 年 1 月 1 日起 6 个月的配药处方数据进行核对。23 名患者被正确确认为接受他莫昔芬处方，43 名患者被确认没有接受他莫昔芬处方。他莫昔芬处方的已知变化反映在处方模式和时间安排上。处方监测已证实，在本次他莫昔芬辅助试验中，所有患者都兑现了他莫昔芬处方。这往往会支持试验结果以及不良事件数据的有效性。它可以用作临床试验中的质量保证方法，并将不良事件与处方历史相关联。
In the Scottish Adjuvant Tamoxifen Trial, patients with operable breast cancer were randomized to adjuvant tamoxifen or to tamoxifen at first recurrence. Sixty-six Tayside patients from this trial were still alive on 1 January 1993, and still living in Tayside. The Medicines Monitoring 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 dispensed prescription data from MEMO for 6 months from 1 January 1993. Twenty-three were correctly confirmed as receiving prescriptions for tamoxifen and 43 confirmed as not. Known changes to tamoxifen prescribing were reflected in the pattern and timing of the prescriptions. Prescription monitoring has confirmed that all patients were redeeming their prescriptions for tamoxifen in this trial of adjuvant tamoxifen. This would tend to support validity of the trial results as well as data on adverse events. It can be used as a method of quality assurance in clinical trials and to correlate adverse events with prescribing history.