地理萎缩的临床试验模拟：患者、护理人员和试验现场工作人员的观点。

IF 2.6 3区医学 Q2 OPHTHALMOLOGY

Ophthalmology and Therapy Pub Date : 2025-08-01 Epub Date: 2025-06-23 DOI:10.1007/s40123-025-01188-x

Ivana Gunderson, Asma Burale, Bill J Best, Cynthia I Tung, Jochen Huber, Lisa Marsh

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引用次数: 0

摘要

在规划新的临床试验时，应考虑地理萎缩（GA）患者的观点，以确保满足现实世界患者的需求。本研究的目的是探讨患者、护理人员和试验现场工作人员在设计和计划GA 2期临床试验方面的观点。方法：这项横断面研究包括GA患者及其护理人员、试验现场工作人员以及来自德国、英国和美国的研究人员。参与者被要求花30分钟的时间回顾一个模拟的试验设计，用一个简单的视频动画和画外音进行交流。随后，进行了90分钟的网络辅助电话访谈和调查，以确定模拟试验设计中的问题，并探讨可能的解决方案和改进措施。结果：患者（n = 11）、护理人员（n = 11）和现场工作人员（n = 16）在回顾模拟试验设计后完成调查。调查结果表明，研究招募可以通过广泛的广告和包括短洗脱期来促进，即患者在开始研究药物之前没有接受任何药物治疗的时间段，以确保其他治疗不会影响研究结果。调查建议减少参与试验的负担，包括尽量减少试验访问的次数和频率，使评估能够在家中完成，并使试验访问的时间表灵活。建议适当投资研究中心设施。此外，调查受访者提出，提供交通工具可能非常有益，可能使患者和护理人员更容易参加试验访问。结论：本研究提供了关于患者、护理人员和试验现场工作人员对试验设计的观点的有价值的信息。在设计未来的临床试验时考虑到这些观点可能有助于确保试验的成功完成，并促进对临床研究的积极看法。

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Clinical Trial Simulation in Geographic Atrophy: Patient, Caregiver, and Trial Site Staff Perspectives.

Introduction: The perspectives of patients with geographic atrophy (GA) should be considered when planning new clinical trials to ensure that real-world patient needs are addressed. The purpose of this study was to explore the perspectives of patients, caregivers, and trial site staff on designing and planning a phase 2 clinical trial in GA.

Methods: This cross-sectional study included patients with GA and their caregivers, trial site staff, and investigators from Germany, the UK, and the USA. Participants were asked to spend 30 min reviewing a simulated trial design communicated as a simple video animation with a voiceover. Subsequently, a 90-min web-assisted telephone interview and survey was conducted to identify problems with the design of the simulated trial and explore potential solutions and improvements.

Results: Patients (n = 11), caregivers (n = 11), and site staff (n = 16) completed the survey after reviewing the simulated trial design. Survey responses suggested that study recruitment could be facilitated via widespread advertisement and by including a short washout period, i.e., the time period during which patients receive no medication prior to commencing the study drug to ensure that other treatments do not impact the study results. Survey suggestions for reducing the burden of trial participation included minimizing the number and frequency of trial visits, enabling assessments to be completed at home, and making the schedule of trial visits flexible. Appropriate investment in study center facilities was recommended. In addition, survey respondents proposed that providing transport could be highly beneficial, potentially enabling patients and caregivers to attend trial visits more easily.

Conclusions: This study provides valuable information on the viewpoints of patients, caregivers, and trial site staff regarding trial design. Accounting for these perspectives when designing future clinical trials may help ensure successful trial completion and promote positive perceptions of clinical research.

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来源期刊

Ophthalmology and Therapy OPHTHALMOLOGY-

CiteScore

4.20

自引率

3.00%

发文量

157

审稿时长

6 weeks

期刊介绍： Aims and Scope Ophthalmology and Therapy is an international, open access, peer-reviewed (single-blind), and rapid publication journal. The scope of the journal is broad and will consider all scientifically sound research from preclinical, clinical (all phases), observational, real-world, and health outcomes research around the use of ophthalmological therapies, devices, and surgical techniques. The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/series, trial protocols and short communications such as commentaries and editorials. Ophthalmology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of quality research, which may be considered of insufficient interest by other journals. Rapid Publication The journal’s publication timelines aim for a rapid peer review of 2 weeks. If an article is accepted it will be published 3–4 weeks from acceptance. The rapid timelines are achieved through the combination of a dedicated in-house editorial team, who manage article workflow, and an extensive Editorial and Advisory Board who assist with peer review. This allows the journal to support the rapid dissemination of research, whilst still providing robust peer review. Combined with the journal’s open access model this allows for the rapid, efficient communication of the latest research and reviews, fostering the advancement of ophthalmic therapies. Open Access All articles published by Ophthalmology and Therapy are open access. 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