背景:关于加拿大分散和混合临床试验的患者和公众观点知之甚少。
方法:我们在社交媒体上进行了一项在线调查(英语和法语),以了解加拿大人对分散和混合临床试验的看法。调查分为两个部分。我们完全与病人共同制作了这个项目,看护人,和家庭伙伴。
结果:该调查有284名(14名法国人)开始或完成第1节的个人,以及180名(16名法国人)开始或完成第2节的个人。人们更喜欢选择参与临床试验,其中方面是分散的或杂交的。79%的受访者更愿意选择与研究访问相关的选项。人们担心分散试验中的不良事件或潜在并发症的处理,然而,参与者的专用联系人等通信选项被认为是有帮助的。大多数受访者都愿意在离家较近的卫星站点或通过技术进行知情同意,并且在隐私问题上存在分歧。最优选在一小时内前往一个地点,取决于试验的目的或其对生活质量的影响.由于回复率,我们无法探索与性别的联系,年龄,健康状况,地理,种族,和先前的临床试验参与。
结论:我们的研究结果表明,加拿大对参与分散或杂交某些方面的试验持开放态度。这些试验被认为为参与者提供了好处,并增加了参与者的公平性和可及性。
BACKGROUND: Little is known about patient and the public perspectives on decentralized and hybrid clinical trials in Canada.
METHODS: We conducted an online survey (English and French) promoted on social media to understand perspectives of people in Canada about decentralized and hybrid clinical trials. The survey had two sections. We co-produced this project entirely with patient, caregiver, and family partners.
RESULTS: The survey had 284 (14 French) individuals who started or completed Section 1, and 180 (16 French) individuals who started or completed Section 2. People prefer to have options to participate in clinical trials where aspects are decentralized or hybridized. 79% of respondents preferred to have options related to study visits. There were concerns about handling adverse events or potential complications in decentralized trials, however, communication options such as a dedicated contact person for participants was deemed helpful. Most respondents were amenable to informed consent being done at a satellite site closer to home or via technology and were split on privacy concerns about this. Most preferred travel to a site within an hour, depending on what the trial was for or its impact on quality of life. Due to the response rate, we were unable to explore associations with gender, age, health status, geography, ethnicity, and prior clinical trial participation.
CONCLUSIONS: Our findings indicate an openness in Canada to participating in trials that decentralize or hybridize some aspects. These trials are perceived to provide benefits to participants and ways to increase equity and accessibility for participants.