Baum Mike
The Portland Hospital, First Floor, 212-214 Great Portland Street, London W1W 5QN, UK.
Eur J Cancer. 2002 Oct;38(15):1984-6. doi: 10.1016/s0959-8049(02)00154-5.
The ATAC ('Arimidex', Tamoxifen, Alone or in Combination) trial is a randomised, double-blind, double-dummy trial, evaluating anastrozole alone or in combination with tamoxifen compared with tamoxifen alone, as a 5-year adjuvant treatment for postmenopausal patients with early breast cancer. The rapid rate of recruitment into this trial was a major achievement, as frequently encountered differences between projected and actual recruitment rates can threaten the successful completion of clinical trials. A questionnaire designed in order to highlight possible factors influencing the success of patient recruitment was completed by 62% of the ATAC trialists. This included 11 statements rated for their level of importance on a three-point scale. The top three motives for recruiting patients were: (1) the attractive scientific rationale of the trial (84%); (2) a design that was easy to explain to patients (79%); and (3) a pragmatic trial design in line with standard practice (76%). A new questionnaire will solicit opinion from the participating patients.
ATAC(“阿那曲唑”、他莫昔芬,单独使用或联合使用)试验是一项随机、双盲、双模拟试验,旨在评估阿那曲唑单独使用或与他莫昔芬联合使用,与单独使用他莫昔芬相比,作为绝经后早期乳腺癌患者的5年辅助治疗方法。该试验快速的入组率是一项重大成就,因为预计招募率与实际招募率之间经常出现的差异可能会威胁到临床试验的成功完成。62%的ATAC试验人员完成了一份旨在突出可能影响患者招募成功的因素的调查问卷。这包括11条按三点量表对其重要性程度进行评分的陈述。招募患者的前三大动机是:(1)试验具有吸引人的科学原理(84%);(2)设计易于向患者解释(79%);(3)符合标准做法的实用试验设计(76%)。一份新的调查问卷将征求参与试验患者的意见。