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参与者对药物临床研究的认知:一项横断面对照研究。

Participants' perception of pharmaceutical clinical research: a cross-sectional controlled study.

作者信息

González-Saldivar Gerardo, Rodríguez-Gutiérrez René, Viramontes-Madrid José Luis, Salcido-Montenegro Alejandro, Carlos-Reyna Kevin Erick Gabriel, Treviño-Alvarez Andrés Marcelo, Álvarez-Villalobos Neri Alejandro, González-González José Gerardo

机构信息

Ophthalmology Department, Hospital Universitario "Dr. José E. González", Facultad de Medicina, Universidad Autónoma de Nuevo León, Monterrey, Nuevo León, Mexico.

Endocrinology Division, Hospital Universitario "Dr. José E. González", Facultad de Medicina, Universidad Autónoma de Nuevo León, Monterrey, Nuevo León, Mexico.

出版信息

Patient Prefer Adherence. 2016 Apr 29;10:727-34. doi: 10.2147/PPA.S96021. eCollection 2016.

Abstract

BACKGROUND

There is scarce scientific information assessing participants' perception of pharmaceutical research in developed and developing countries concerning the risks, safety, and purpose of clinical trials.

METHODS

To assess the perception that 604 trial participants (cases) and 604 nonparticipants (controls) of pharmaceutical clinical trials have about pharmaceutical clinical research, we surveyed participants with one of four chronic diseases from 12 research sites throughout Mexico.

RESULTS

Participation in clinical trials positively influences the perception of pharmaceutical clinical research. More cases (65.4%) than controls (50.7%) perceived that the main purpose of pharmaceutical research is to cure more diseases and to do so more effectively. In addition, more cases considered that there are significant benefits when participating in a research study, such as excellent medical care and extra free services, with this being the most important motivation to participate for both groups (cases 52%, controls 54.5%). We also found a sense of trust in their physicians to deal with adverse events, and the perception that clinical research is a benefit to their health, rather than a risk. More controls believed that clinical trial participants' health is put at risk (57% vs 33.3%). More cases (99.2%) than controls (77.5%) would recommend participating in a clinical trial, and 90% of cases would enroll in a clinical trial again.

CONCLUSION

Participation in clinical trials positively influences the perception that participants have about pharmaceutical clinical research when compared to nonparticipants. This information needs to be conveyed to clinicians, public health authorities, and general population to overcome misconceptions.

摘要

背景

在发达国家和发展中国家,评估参与者对药物研究中临床试验的风险、安全性及目的的认知的科学信息稀缺。

方法

为评估604名药物临床试验参与者(病例组)和604名非参与者(对照组)对药物临床研究的认知,我们对来自墨西哥12个研究地点的四种慢性病患者进行了调查。

结果

参与临床试验对药物临床研究的认知有积极影响。认为药物研究的主要目的是治愈更多疾病且更有效的病例组(65.4%)多于对照组(50.7%)。此外,更多病例组认为参与研究有显著益处,如优质医疗护理和额外免费服务,这是两组参与的最重要动机(病例组52%,对照组54.5%)。我们还发现他们对医生处理不良事件有信任感,且认为临床研究对健康有益而非有风险。更多对照组认为临床试验参与者的健康有风险(57%对33.3%)。病例组(99.2%)比对照组(77.5%)更愿意推荐参与临床试验,90%的病例组会再次参加临床试验。

结论

与非参与者相比,参与临床试验对参与者对药物临床研究的认知有积极影响。需要将此信息传达给临床医生、公共卫生当局和普通民众,以消除误解。

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