Grand Melissa M, O'Brien Peter C
TROG Cancer Research, Calvary Mater Newcastle Calvary Mater Newcastle University of Newcastle, HRMC, New South Wales, Australia.
J Med Imaging Radiat Oncol. 2012 Feb;56(1):31-9. doi: 10.1111/j.1754-9485.2011.02337.x.
Accrual to clinical trials continues to be a problem in many countries including Australia despite its fundamental importance to the progress of evidence-based medicine. This paper reviews the current literature addressing the obstacles to accrual excluding those related to protocol design. An electronic search of the literature identified publications in oncology specifically addressing the obstacles to participation in clinical trials. This search was supplemented by searches of key oncology journals. Obstacles fall into three main categories - clinician, patient and system; however, there are overlaps between categories. Clinician behaviour is the most important of these. Exclusion of patients for reasons other than defined eligibility criteria, concerns about increased time requirements, and suboptimal communication with patients all affect accrual. Risk management strategies for clinical trials need to be individualised to address the obstacles most likely to negatively impact on accrual. Communication between clinician and patient appears to be a greater issue than previously recognised. Time concerns need to be addressed as generational change affects the expectations of the medical workforce.
尽管临床试验入组对循证医学的发展至关重要，但在包括澳大利亚在内的许多国家，临床试验入组仍然是一个问题。本文综述了当前关于入组障碍的文献，不包括与方案设计相关的障碍。通过电子检索文献，确定了肿瘤学领域专门论述参与临床试验障碍的出版物。通过检索主要肿瘤学期刊对这一检索进行了补充。障碍主要分为三类——临床医生、患者和系统；然而，各类别之间存在重叠。其中临床医生的行为最为重要。因既定合格标准以外的原因排除患者、对时间要求增加的担忧以及与患者沟通欠佳都会影响入组。临床试验的风险管理策略需要个性化，以解决最有可能对入组产生负面影响的障碍。临床医生与患者之间的沟通似乎是一个比以往认识到的更大的问题。由于代际变化影响医疗劳动力的期望，需要解决对时间的担忧。
