加拿大患者和公众对分散和混合临床试验的看法:"是时候把试验带到人们身边了"。

IF 2 4区 医学 Q4 MEDICAL INFORMATICS Therapeutic innovation & regulatory science Pub Date : 2024-09-01 Epub Date: 2024-06-21 DOI:10.1007/s43441-024-00665-y
Dawn P Richards, John Queenan, Linnea Aasen-Johnston, Heather Douglas, Terry Hawrysh, Michael Lapenna, Donna Lillie, Emily I McIntosh, Jenna Shea, Maureen Smith, Susan Marlin
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引用次数: 0

摘要

背景:人们对加拿大患者和公众对分散和混合临床试验的看法知之甚少:我们在社交媒体上开展了一项在线调查(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。我们与患者、护理人员和家庭合作伙伴共同完成了这一项目:调查中有 284 人(14 名法国人)开始或完成了第一部分,180 人(16 名法国人)开始或完成了第二部分。人们更愿意选择参与分散或混合的临床试验。79%的受访者倾向于拥有与研究考察相关的选择权。有人担心在分散试验中如何处理不良事件或潜在的并发症,不过,他们认为专门的参试者联系人等沟通方式很有帮助。大多数受访者同意在离家较近的卫星试验点或通过技术手段进行知情同意,但在隐私问题上存在分歧。根据试验的目的或对生活质量的影响,大多数人倾向于在一小时内前往试验地点。由于回复率的原因,我们无法探讨与性别、年龄、健康状况、地理位置、种族和之前参与临床试验的关系:我们的研究结果表明,加拿大对参与分散或混合某些方面的试验持开放态度。这些试验被认为能为参与者带来益处,并能提高参与者的公平性和可及性。
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Patient and Public Perceptions in Canada About Decentralized and Hybrid Clinical Trials: "It's About Time we Bring Trials to People".

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.

Conclusion: 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.

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来源期刊
Therapeutic innovation & regulatory science
Therapeutic innovation & regulatory science MEDICAL INFORMATICS-PHARMACOLOGY & PHARMACY
CiteScore
3.40
自引率
13.30%
发文量
127
期刊介绍: Therapeutic Innovation & Regulatory Science (TIRS) is the official scientific journal of DIA that strives to advance medical product discovery, development, regulation, and use through the publication of peer-reviewed original and review articles, commentaries, and letters to the editor across the spectrum of converting biomedical science into practical solutions to advance human health. The focus areas of the journal are as follows: Biostatistics Clinical Trials Product Development and Innovation Global Perspectives Policy Regulatory Science Product Safety Special Populations
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