Background: The clinical trials of new anti-tumor drugs are prospering in China. The acceptance of clinical trials in patients is an important factor affecting the speed and quality of clinical trials. Previous studies have investigated the acceptance of clinical trials in those cancer patients, who have never participated in a trial. This study is designed to investigate and compare the acceptance and related causes of clinical trials in cancer patients who have once participated in a clinical trial or not.
Methods: From June 2018 to April 2019, a standardized questionnaire-based survey was conducted among two groups of cancer patients classified by history of clinical trial participation in Cancer hospital, Chinese Academy of Medical Science, mainly focusing on their overall acceptance of clinical trials and related considerations, including the role of attending doctors, as well as group differences between the two participants.
Results: A total of 538 patients were enrolled with an average age of 53.5 years old, 51.1% of whom were males, and 43.3% of whom have never participated in a clinical trial. Overall, 502 patients (93.3%) were willing to or recommend their relatives or friends to participate in clinical trials, and patients with history of clinical trial participation had higher willingness (96.6% vs 90.8%, P=0.008). Patients were most likely to be motivated by expectation of optimal treatment (100.0% vs 99.3%) for both those who had once participated in a clinical trial or those not, respectively followed by financial burden reduction (56.0%) and recommendation by attending doctor (43.7%). The main reasons for unwillingness-to-participate for those who had once participated in a clinical trial were abandoning other treatment options, divided into control group or additional visits, while for those who had never participated in a clinical trial, ineffective treatment or serious adverse reactions were their main concerns. In the decision-making of clinical trial participation, 88% patients highly valued the role of recommendation by attending doctors. Among patients without trial participation history, 60.9% of those had no unwillingness-to-participate expressed that recommendation by attending doctors would change their decisions. The study also reported patients' preferences for information and access to clinical trials.
Conclusions: The acceptance of clinical trials in cancer patients in our hospital is generally high, especially in patients who had a history of trial participation. It's of substantial significance to give full play to the role of doctors in improving the acceptance of clinical trials of cancer patients in China.
【中文题目：肿瘤患者临床试验接受意愿及相关原因分析】 【中文摘要：背景与目的 我国的抗肿瘤新药临床试验开展如火如荼，患者的临床试验接受度是影响临床试验开展速度和质量的重要因素。既往研究仅针对未参与过临床试验的肿瘤患者接受度展开调查，未分析参加过临床试验患者的相关情况。本研究调查并比较参加过和未参与过试验的肿瘤患者对于临床试验的接受度，并分析相关原因。方法 2018年6月-2019年4月，采用标准化问卷在中国医学科学院肿瘤医院针对肿瘤患者（参加过 vs 未参加过试验）开展调查，分析比较两组患者临床试验的接受度和差异，并分析主要原因及医生对其接受度的影响。结果 共纳入538例患者，男性51.1%，平均年龄53.5岁，43.3%的患者参加过试验。总体而言，502例（93.3%）患者愿意参加或推荐亲友参加试验，参加过试验的患者接受度较高（96.6% vs 90.8%, P=0.008）。参加过和未参加过试验患者愿意的最主要原因均为“期待最佳治疗效果”（100.0% vs 99.3%），次要原因分别为“可减轻经济负担”（56.0%）和“主治医生建议”（43.7%）。参加过试验的患者不愿意参加的主要原因为“放弃其他治疗选择”、“分到对照治疗组”或“额外访视影响生活”；未参加过试验的患者为“治疗效果不佳”或“出现严重不良反应”。对参加过试验的患者，医生推荐对88%患者参与试验的决策起到关键作用；对未参加过试验的患者，医生推荐可使60.9%无参与意愿者改变其选择。研究也报告了患者对临床试验获取信息和途径等的倾向选择。结论 肿瘤患者临床试验接受度普遍较高，尤其是参加过试验的患者。充分发挥主治医生的作用对提高我国肿瘤患者临床试验接受度有重要意义。】 【中文关键词：肿瘤；临床试验；接受度；参与意愿】.
Keywords: Acceptance; Cancer; Clinical trial; Willingness-to-participate.