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
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。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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 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. Personal Service The journal’s dedicated in-house editorial team offer a personal “concierge service” meaning authors will always have an editorial contact able to update them on the status of their manuscript. The editorial team check all manuscripts to ensure that articles conform to the most recent COPE, GPP and ICMJE publishing guidelines. This supports the publication of ethically sound and transparent research. Digital Features and Plain Language Summaries Ophthalmology and Therapy offers a range of additional features designed to increase the visibility, readership and educational value of the journal’s content. Each article is accompanied by key summary points, giving a time-efficient overview of the content to a wide readership. Articles may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand the scientific content and overall implications of the article. The journal also provides the option to include various types of digital features including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations. All additional features are peer reviewed to the same high standard as the article itself. If you consider that your paper would benefit from the inclusion of a digital feature, please let us know. Our editorial team are able to create high-quality slide decks and infographics in-house, and video abstracts through our partner Research Square, and would be happy to assist in any way we can. For further information about digital features, please contact the journal editor (see ‘Contact the Journal’ for email address), and see the ‘Guidelines for digital features and plain language summaries’ document under ‘Submission guidelines’. For examples of digital features please visit our showcase page https://springerhealthcare.com/expertise/publishing-digital-features/ Publication Fees Upon acceptance of an article, authors will be required to pay the mandatory Rapid Service Fee of €5250/$6000/£4300. The journal will consider fee discounts and waivers for developing countries and this is decided on a case by case basis. Peer Review Process Upon submission, manuscripts are assessed by the editorial team to ensure they fit within the aims and scope of the journal and are also checked for plagiarism. All suitable submissions are then subject to a comprehensive single-blind peer review. Reviewers are selected based on their relevant expertise and publication history in the subject area. The journal has an extensive pool of editorial and advisory board members who have been selected to assist with peer review based on the afore-mentioned criteria. At least two extensive reviews are required to make the editorial decision, with the exception of some article types such as Commentaries, Editorials, and Letters which are generally reviewed by one member of the Editorial Board. Where reviewer recommendations are conflicted, the editorial board will be contacted for further advice and a presiding decision. Manuscripts are then either accepted, rejected or authors are required to make major or minor revisions (both reviewer comments and editorial comments may need to be addressed). Once a revised manuscript is re-submitted, it is assessed along with the responses to reviewer comments and if it has been adequately revised it will be accepted for publication. Accepted manuscripts are then copyedited and typeset by the production team before online publication. Appeals against decisions following peer review are considered on a case-by-case basis and should be sent to the journal editor. Preprints We encourage posting of preprints of primary research manuscripts on preprint servers, authors’ or institutional websites, and open communications between researchers whether on community preprint servers or preprint commenting platforms. Posting of preprints is not considered prior publication and will not jeopardize consideration in our journals. Authors should disclose details of preprint posting during the submission process or at any other point during consideration in one of our journals. Once the manuscript is published, it is the author’s responsibility to ensure that the preprint record is updated with a publication reference, including the DOI and a URL link to the published version of the article on the journal website. Please follow the link for further information on preprint sharing: https://www.springer.com/gp/authors-editors/journal-author/journal-author-helpdesk/submission/1302#c16721550 Copyright Ophthalmology and Therapy''s content is published open access under the Creative Commons Attribution-Noncommercial License, which allows users to read, copy, distribute, and make derivative works for non-commercial purposes from the material, as long as the author of the original work is cited. The author assigns the exclusive right to any commercial use of the article to Springer. For more information about the Creative Commons Attribution-Noncommercial License, click here: http://creativecommons.org/licenses/by-nc/4.0. Contact For more information about the journal, including pre-submission enquiries, please contact christopher.vautrinot@springer.com.
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