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提高加纳社区对临床试验的参与度;需考虑的因素。

Improving community participation in clinical trials in Ghana; factors to consider.

作者信息

Appeaning Mark, Owusu-Asante Helen, Kwofie Samuel, Arhin George, Asamoah Andrew Oppong, Ali Tawfic, Amponsah Reginald Roland

机构信息

Department of Medical Laboratory Science, Faculty of Health and Allied Sciences, Koforidua Technical University, P.O. Box KF 981, 00233, Koforidua, Ghana.

Department of Biochemistry, Cell and Molecular Biology, University of Ghana, P.O. Box LG 25, Legon, Accra, Ghana.

出版信息

Contemp Clin Trials Commun. 2022 Oct 3;30:101012. doi: 10.1016/j.conctc.2022.101012. eCollection 2022 Dec.

Abstract

INTRODUCTION

Clinical trials are an essential part of drug and vaccine development, as well as the development of new biomedical devices, and medical procedures. Successful enrolment of human volunteers is important to the success of any clinical trial anywhere around the globe. Enrolment is however affected by a number of factors including knowledge, attitudes, and perceptions (KAPs). We aimed to determine factors that are deemed important in improving participation in clinical trials within a Ghanaian community.

METHOD

This was a cross-sectional study that employed a structured questionnaire within the New Juaben South Municipal Assembly (NJSMA). Participants who were 18 years and above were included in this study. There were a total of 639 participants in this study. Participants' demographics were collected and various questions were asked to assess their KAP towards participation in clinical trials.

RESULTS

The mean age of participants was 29.03 ± 8.95 years, there were more males (51.96%) than females, 42.35% had tertiary education, 38.03% were artisans, 74.80% were Christians and 14.40% had previously participated in a clinical trial. Participants had average knowledge about clinical trials (CT) with a mean score of 7.56 ± 1.76 (63%). A significant association between knowledge levels and education was observed (χ2 = 100.3, p < 0.0001). Helping in advancing the medical knowledge was the key reason for participation in CT while mistrust of the medical system was the key setback in participation in CT. There was a generally positive attitude and a neutral perception towards participation in CTs.

CONCLUSION

Groups intending to conduct CT should highlight the benefits of CT and address the perception of mistrust in the conduct of CTs in their education and sensitization programs before initiation of CTs in Ghana.

摘要

引言

临床试验是药物和疫苗研发、新型生物医学设备及医疗程序研发的重要组成部分。在全球任何地方,成功招募人类志愿者对任何临床试验的成功都至关重要。然而,招募会受到多种因素的影响,包括知识、态度和认知(KAPs)。我们旨在确定在加纳一个社区中,哪些因素被认为对提高临床试验参与度很重要。

方法

这是一项横断面研究,在新朱阿本南市政议会(NJSMA)内使用结构化问卷。18岁及以上的参与者被纳入本研究。本研究共有639名参与者。收集了参与者的人口统计学信息,并询问了各种问题以评估他们对参与临床试验的KAP。

结果

参与者的平均年龄为29.03±8.95岁,男性(51.96%)多于女性,42.35%拥有高等教育学历,38.03%是工匠,74.80%是基督徒,14.40%曾参与过临床试验。参与者对临床试验(CT)的知识水平一般,平均得分为7.56±1.76(63%)。观察到知识水平与教育程度之间存在显著关联(χ2 = 100.3,p < 0.0001)。帮助推进医学知识是参与CT的主要原因,而对医疗系统的不信任是参与CT的主要障碍。对参与CT总体上持积极态度和中立看法。

结论

打算进行CT的团体在加纳启动CT之前,应在其教育和宣传项目中突出CT的益处,并解决对CT实施过程中不信任的看法。

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