Factors influencing patients' decisions regarding participation in clinical trials: Review of current literature.

IF 2.1 4区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL
Dariusz Olszewski, Aneta Tomaszewska, Bolesław Samolinski
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引用次数: 0

Abstract

Obtaining timely data in clinical trials (CTs) is critical for drug registration. This depends directly on the speed at which patients are recruited. This paper provides an overview of selected scientific works and literature from different countries about patients' motivators and barriers to participating in CTs From 55 articles retrieved from PubMed, 5 were selected for the analysis. Additionally, 6 publications, including 2 by Polish authors, were reviewed. As a result, we identified 10 factors for further investigation: altruism, hope for personal benefit, access to better care, the role of a doctor, the opinions of close friends or relatives, financial compensation, side effects, the patient's role as a guinea pig, effort and time, and the use of placebo. Regardless of the therapeutic area, health status, study phase, country, geographic area, economic situation, or healthcare system, patients indicated very similar reasons when deciding to participate in a CT. Even if patients as a group had similar motives and concerns, there are individual elements or unusual factors that need to be better understood and evaluated to accelerate the recruitment process in order to avoid certain drugs or therapies being overlooked or underestimated. In this way, investigators can help patients make the best decisions and more effectively support the process of registering a new drug. Future research on factors influencing patients' decisions is still necessary: We do not know how the COVID-19 pandemic may have influenced patient motivation, how new regulations on CTs are changing patients' perceptions of CTs, and what may be important depending on the study, country, therapeutic area and other factors.

影响患者决定参与临床试验的因素:当前文献综述。
在临床试验(CT)中及时获取数据对于药物注册至关重要。这直接取决于招募患者的速度。本文概述了不同国家关于患者参与临床试验的动机和障碍的部分科学著作和文献 从 PubMed 上检索到的 55 篇文章中,有 5 篇被选中进行分析。此外,我们还查阅了 6 篇出版物,其中包括 2 篇由波兰作者撰写的出版物。因此,我们确定了 10 个需要进一步研究的因素:利他主义、希望个人受益、获得更好的医疗服务、医生的角色、亲友的意见、经济补偿、副作用、患者的小白鼠角色、精力和时间以及安慰剂的使用。无论治疗领域、健康状况、研究阶段、国家、地理区域、经济状况或医疗保健系统如何,患者在决定参与 CT 时所表达的原因都非常相似。即使患者作为一个群体具有相似的动机和顾虑,但仍有一些个体因素或异常因素需要更好地了解和评估,以加快招募过程,避免某些药物或疗法被忽视或低估。这样,研究人员就能帮助患者做出最佳决定,更有效地支持新药注册过程。未来仍有必要对影响患者决定的因素进行研究:我们不知道 COVID-19 大流行如何影响了患者的动机,关于 CT 的新法规如何改变了患者对 CT 的看法,以及根据研究、国家、治疗领域和其他因素的不同,哪些因素可能是重要的。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Advances in Clinical and Experimental Medicine
Advances in Clinical and Experimental Medicine MEDICINE, RESEARCH & EXPERIMENTAL-
CiteScore
3.70
自引率
4.80%
发文量
153
审稿时长
6-12 weeks
期刊介绍: Advances in Clinical and Experimental Medicine has been published by the Wroclaw Medical University since 1992. Establishing the medical journal was the idea of Prof. Bogumił Halawa, Chair of the Department of Cardiology, and was fully supported by the Rector of Wroclaw Medical University, Prof. Zbigniew Knapik. Prof. Halawa was also the first editor-in-chief, between 1992-1997. The journal, then entitled "Postępy Medycyny Klinicznej i Doświadczalnej", appeared quarterly. Prof. Leszek Paradowski was editor-in-chief from 1997-1999. In 1998 he initiated alterations in the profile and cover design of the journal which were accepted by the Editorial Board. The title was changed to Advances in Clinical and Experimental Medicine. Articles in English were welcomed. A number of outstanding representatives of medical science from Poland and abroad were invited to participate in the newly established International Editorial Staff. Prof. Antonina Harłozińska-Szmyrka was editor-in-chief in years 2000-2005, in years 2006-2007 once again prof. Leszek Paradowski and prof. Maria Podolak-Dawidziak was editor-in-chief in years 2008-2016. Since 2017 the editor-in chief is prof. Maciej Bagłaj. Since July 2005, original papers have been published only in English. Case reports are no longer accepted. The manuscripts are reviewed by two independent reviewers and a statistical reviewer, and English texts are proofread by a native speaker. The journal has been indexed in several databases: Scopus, Ulrich’sTM International Periodicals Directory, Index Copernicus and since 2007 in Thomson Reuters databases: Science Citation Index Expanded i Journal Citation Reports/Science Edition. In 2010 the journal obtained Impact Factor which is now 1.179 pts. Articles published in the journal are worth 15 points among Polish journals according to the Polish Committee for Scientific Research and 169.43 points according to the Index Copernicus. Since November 7, 2012, Advances in Clinical and Experimental Medicine has been indexed and included in National Library of Medicine’s MEDLINE database. English abstracts printed in the journal are included and searchable using PubMed http://www.ncbi.nlm.nih.gov/pubmed.
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