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波兰从未参与过临床试验的肿瘤患者对临床试验的认知与态度。

Awareness and attitudes towards clinical trials among Polish oncological patients who had never participated in a clinical trial.

作者信息

Staniszewska Anna, Lubiejewska Adriana, Czerw Aleksandra, Dąbrowska-Bender Marta, Duda-Zalewska Aneta, Olejniczak Dominik, Juszczyk Grzegorz, Bujalska-Zadrożny Magdalena

机构信息

Department of Experimental and Clinical Pharmacology, Medical University of Warsaw, Poland.

ICON Clinical Research, Warszawa, Poland.

出版信息

Adv Clin Exp Med. 2018 Apr;27(4):525-529. doi: 10.17219/acem/68762.

Abstract

BACKGROUND

Participation in a clinical trial significantly shortens waiting time associated with receiving specialist care. Furthermore, it may be the case that, through clinical trials, subjects can access medicines that are not typically available in Poland.

OBJECTIVES

The aim of this study was to determine the opinions of oncological patients about clinical trials.

MATERIAL AND METHODS

The research has been carried out during the years 2014-2016. A proprietary questionnaire consisting of 10 closed, single and multiple choice questions about awareness and perceptions of clinical trials, and 5 questions concerning demographic information was used. A group of 256 patients with cancer (54% women, 46% men), aged 21-77 years, was surveyed.

RESULTS

Respondents were statistically more likely to decide to participate in a clinical trial as oncological patients than the healthy volunteers (Pearson's χ2 test p = 0.00006). The desire to qualify for clinical trials in no way depends on the knowledge of side effects (Pearson's χ2 test p = 0.16796).

CONCLUSIONS

Our study found that the patients' awareness about clinical trials varied. However, a positive attitude towards research was visible. The main identified barriers to clinical trial participation were fear of possible side effects. Most patients regarded clinical trials as useful, and considered that they are conducted to introduce new treatment/new drug.

摘要

背景

参与临床试验可显著缩短接受专科护理的等待时间。此外,通过临床试验,受试者有可能获得波兰通常无法获得的药物。

目的

本研究旨在确定肿瘤患者对临床试验的看法。

材料与方法

研究于2014年至2016年期间进行。使用了一份自制问卷,其中包括10个关于对临床试验的认知和看法的封闭式单项和多项选择题,以及5个关于人口统计学信息的问题。对一组256名年龄在21至77岁之间的癌症患者(54%为女性,46%为男性)进行了调查。

结果

与健康志愿者相比,作为肿瘤患者的受访者在统计学上更有可能决定参与临床试验(Pearson卡方检验p = 0.00006)。参与临床试验的意愿与对副作用的了解毫无关系(Pearson卡方检验p = 0.16796)。

结论

我们的研究发现,患者对临床试验的认知各不相同。然而,对研究的积极态度是显而易见的。确定的参与临床试验的主要障碍是对可能出现的副作用的恐惧。大多数患者认为临床试验是有用的,并认为进行临床试验是为了引入新的治疗方法/新药。

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