Melisko Michelle E, Hassin Fern, Metzroth Lauren, Moore Dan H, Brown Beth, Patel Kiran, Rugo Hope S, Tripathy Debu
University of California, San Francisco, USA.
Clin Breast Cancer. 2005 Apr;6(1):45-54. doi: 10.3816/CBC.2005.n.008.
Clinical trials are essential to develop and test novel therapies, yet only 2%-3% of women with breast cancer enroll. We sought to describe patient and physician barriers to trial participation and then implemented targeted interventions to increase awareness and interest in trial participation. Also, with increasing patient interest in complementary and alternative medicine (CAM) for cancer, we explored attitudes regarding CAM clinical trials.
Between 1997 and 2000, questionnaires were offered to patients with newly diagnosed or recurrent breast cancer and to physicians specializing in breast cancer. Programs aimed at patients and physicians from our geographic region to increase their support for breast cancer clinical trials were initiated in 1997. Correlation between perceived barriers and patient and physician demographics were explored. Reluctance to be randomized, extra time, and concerns about worse side effects with the experimental arm were the most significant patient barriers. Physician barriers included randomization, extra staff time, and increased costs of enrollment. Patients and physicians approved of studying CAM in clinical trials, with different scores based on age and type of practice. Physicians and patients developed more favorable views of clinical trials between 1997 and 2000.
Although many barriers still exist, this study suggests that attitudes toward clinical trials are evolving and significantly affected by patient age and stage of disease. Because different patients and some different physicians were surveyed, it is difficult to conclude that the changes occurred as a result of the interventions.
Future efforts to improve enrollment should focus on patients' individual concerns and the uneasiness with the randomization.
临床试验对于开发和测试新疗法至关重要，但仅有2%-3%的乳腺癌女性患者参与其中。我们试图描述患者和医生参与试验的障碍，然后实施针对性干预措施以提高对试验参与的认知和兴趣。此外，随着患者对癌症补充和替代医学（CAM）兴趣的增加，我们探讨了对CAM临床试验的态度。
1997年至2000年间，向新诊断或复发乳腺癌患者以及乳腺癌专科医生发放问卷。1997年启动了针对我们所在地理区域患者和医生的项目，以增加他们对乳腺癌临床试验的支持。探讨了感知到的障碍与患者和医生人口统计学特征之间的相关性。不愿被随机分组、额外时间以及对试验组更严重副作用的担忧是患者最主要的障碍。医生的障碍包括随机分组、额外的工作人员时间以及增加的入组成本。患者和医生赞成在临床试验中研究CAM，根据年龄和执业类型得分不同。1997年至2000年间，医生和患者对临床试验的看法更为积极。
尽管仍然存在许多障碍，但本研究表明对临床试验的态度正在演变，且受患者年龄和疾病阶段的显著影响。由于调查的是不同患者和部分不同医生，难以得出这些变化是干预措施所致的结论。
未来提高入组率的努力应聚焦于患者的个人担忧以及对随机分组的不安。
