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医生参与临床研究与试验:问题与方法

Physician participation in clinical research and trials: issues and approaches.

作者信息

Rahman Sayeeda, Majumder Md Anwarul Azim, Shaban Sami F, Rahman Nuzhat, Ahmed Moslehuddin, Abdulrahman Khalid Bin, D'Souza Urban Ja

机构信息

Department of Clinical Sciences, School of Life Sciences, University of Bradford, West Yorkshire, Bradford, UK.

出版信息

Adv Med Educ Pract. 2011 Mar 7;2:85-93. doi: 10.2147/AMEP.S14103. Print 2011.

Abstract

The rapid development of new drugs, therapies, and devices has created a dramatic increase in the number of clinical research studies that highlights the need for greater participation in research by physicians as well as patients. Furthermore, the potential of clinical research is unlikely to be reached without greater participation of physicians in research. Physicians face a variety of barriers with regard to participation in clinical research. These barriers are system-or organization-related as well as research-and physician-related. To encourage physician participation, appropriate organizational and operational infrastructures are needed in health care institutes to support research planning and management. All physicians should receive education and training in the fundamentals of research design and methodology, which need to be incorporated into undergraduate medical education and postgraduate training curricula and then reinforced through continuing medical education. Medical schools need to analyze current practices of teaching-learning and research, and reflect upon possible changes needed to develop a 'student-focused teaching-learning and research culture'. This article examines the barriers to and benefits of physician participation in clinical research as well as interventions needed to increase their participation, including the specific role of undergraduate medical education. The main challenge is the unwillingness of many physicians and patients to participate in clinical trials. Barriers to participation include lack of time, lack of resources, trial-specific issues, communication difficulties, conflicts between the role of clinician and scientist, inadequate research experience and training for physicians, lack of rewards and recognition for physicians, and sometimes a scientifically uninteresting research question, among others. Strategies to encourage physician participation in clinical research include financial and nonfinancial incentives, adequate training, research questions that are in line with physician interests and have clear potential to improve patient care, and regular feedback. Finally, encouraging research culture and fostering the development of inquiry and research-based learning among medical students is now a high priority in order to develop more and better clinician-researchers.

摘要

新药、疗法和设备的迅速发展使得临床研究的数量急剧增加,这凸显了医生和患者更多地参与研究的必要性。此外,如果没有医生更多地参与研究,临床研究的潜力就不太可能得到充分发挥。医生在参与临床研究方面面临各种障碍。这些障碍既与系统或组织相关,也与研究和医生相关。为鼓励医生参与,医疗机构需要适当的组织和运营基础设施来支持研究规划和管理。所有医生都应接受研究设计和方法基础的教育和培训,这需要纳入本科医学教育和研究生培训课程,并通过继续医学教育加以强化。医学院校需要分析当前的教学与研究实践,并思考为培养“以学生为中心的教学与研究文化”所需的可能变化。本文探讨了医生参与临床研究的障碍和益处,以及增加他们参与度所需的干预措施,包括本科医学教育的具体作用。主要挑战在于许多医生和患者不愿意参与临床试验。参与的障碍包括时间不足、资源匮乏、特定试验问题、沟通困难、临床医生与科学家角色之间的冲突、医生缺乏足够的研究经验和培训、对医生缺乏奖励和认可,以及有时研究问题在科学上缺乏趣味性等。鼓励医生参与临床研究的策略包括经济和非经济激励、充分的培训、符合医生兴趣且有明显改善患者护理潜力的研究问题,以及定期反馈。最后,鼓励研究文化并促进医学生基于探究和研究的学习发展,现在是培养更多更好的临床医生 - 研究人员的当务之急。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b140/3661249/ddd16a4059e6/amep-2-085f1.jpg

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