Avis Nancy E, Smith Kevin W, Link Carol L, Hortobagyi Gabriel N, Rivera Edgardo
Department of Public Health Sciences, Wake Forest University School of Medicine, Winston-Salem, NC 27157-1063, USA.
J Clin Oncol. 2006 Apr 20;24(12):1860-7. doi: 10.1200/JCO.2005.03.8976.
It is well established that recruitment to clinical trials (CTs) is difficult and time consuming. This article reports on factors related to CT participation among women who were invited to participate in a CT for breast cancer.
Breast cancer patients who were eligible for a CT were identified by 16 different cancer centers. After their invitation to participate in a trial, patients who were undecided about participation in a CT were recruited into the present study at that time. After a patient made a decision about trial participation, a telephone interview was conducted to assess knowledge of CTs, perceived benefits and drawbacks of CTs, and personal factors affecting the women's decision regarding participation.
A total of 208 patients participated in the study. Fifty-eight percent of the patients decided to participate in a trial. Logistic regression analyses showed that the factors best explaining participation were trial phase, perceived drawbacks, time and travel considerations, therapeutic benefit of trial, and physician recommendation. Participation rates were similar for both phase I and phase III trials. However, a higher percentage of women recruited to phase II trials accepted.
This study suggests that reducing drawbacks of CT participation, particularly travel time, and improving physician communication of trials are needed to increase trial participation.
临床试验（CT）的受试者招募困难且耗时，这一点已得到充分证实。本文报告了受邀参加乳腺癌CT的女性中与参与CT相关的因素。
16个不同的癌症中心确定了符合CT条件的乳腺癌患者。在邀请她们参与试验后，当时对是否参与CT犹豫不决的患者被纳入本研究。患者做出参与试验的决定后，进行电话访谈以评估对CT的了解、对CT利弊的认知以及影响女性参与决定的个人因素。
共有208名患者参与了研究。58%的患者决定参与试验。逻辑回归分析表明，最能解释参与情况的因素是试验阶段、感知到的弊端、时间和出行考虑、试验的治疗益处以及医生的推荐。I期和III期试验的参与率相似。然而，被招募到II期试验的女性接受率更高。
本研究表明，需要减少参与CT的弊端，尤其是出行时间，并改善医生对试验的沟通，以提高试验参与率。
