Mills Edward J, Seely Dugald, Rachlis Beth, Griffith Lauren, Wu Ping, Wilson Kumanan, Ellis Peter, Wright James R
Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Canada.
Lancet Oncol. 2006 Feb;7(2):141-8. doi: 10.1016/S1470-2045(06)70576-9.
Enrolling participants onto clinical trials of cancer presents an important challenge. We aimed to identify the concerns of patients with cancer about, and the barriers to, participation in clinical trials.
We did a systematic review to assess studies of barriers to participation in experimental trials and randomised trials for validity and content. We estimated the frequency with which patients identified particular issues by pooling across studies that presented data for barriers to participation in clinical trials as proportions.
We analysed 12 qualitative studies (n=722) and 21 quantitative studies (n=5452). Two qualitative studies inquired of patients who were currently enrolled onto clinical trials, and ten inquired of patients who were eligible for enrolment onto various clinical trials. Barriers to participation in clinical trials were protocol-related, patient-related, or physician-related. The most common reasons cited as barriers included: concerns with the trial setting; a dislike of randomisation; general discomfort with the research process; complexity and stringency of the protocol; presence of a placebo or no-treatment group; potential side-effects; being unaware of trial opportunities; the idea that clinical trials are not appropriate for serious diseases; fear that trial involvement would have a negative effect on the relationship with their physician; and their physician's attitudes towards the trial. Meta-analysis confirmed the findings of our systematic review.
The identification of such barriers to the participation in clinical trials should help trialists to develop strategies that will keep to a maximum participation and cooperation in cancer trials, while informing and protecting prospective participants adequately.
招募参与者参加癌症临床试验是一项重大挑战。我们旨在确定癌症患者对参与临床试验的担忧以及参与的障碍。
我们进行了一项系统评价，以评估关于参与实验性试验和随机试验的障碍的研究的有效性和内容。我们通过汇总那些将参与临床试验的障碍数据以比例形式呈现的研究，来估计患者指出特定问题的频率。
我们分析了12项定性研究（n = 722）和21项定量研究（n = 5452）。两项定性研究询问了目前已参加临床试验的患者，十项研究询问了有资格参加各种临床试验的患者。参与临床试验的障碍与方案相关、与患者相关或与医生相关。被提及最多的障碍原因包括：对试验环境的担忧；不喜欢随机分组；对研究过程普遍感到不适；方案的复杂性和严格性；存在安慰剂或无治疗组；潜在的副作用；不知道有试验机会；认为临床试验不适用于严重疾病；担心参与试验会对与医生的关系产生负面影响；以及医生对试验的态度。荟萃分析证实了我们系统评价的结果。
识别这些参与临床试验的障碍应有助于试验者制定策略，以最大限度地提高癌症试验中的参与率和合作率，同时充分告知并保护潜在参与者。
