临床试验要关注患者而不是器械或药物
发布于:2010-09-21 12:45
Clinical Trials Focus on Patients not Device or Pharma
——interview with Dr. Roxana Mehran
您对于未来临床试验的方向有何见解?
临床试验未来全球性的合作将越来越多,试验必须入选世界各地的患者来进一步提高我们对于世界不同地区患者结果的认识。这会提高未来临床试验的质量和效用。而且,临床试验要回答的问题将会而且必须以患者为中心而不是器械或者药物,这将促成多学科合作治疗心脏病以完成改善患者预后的使命。
对于中国临床试验的评价
中国已经走在开展临床试验的道路上,致力于在科学整合、患者治疗和有效性环境内开展高质量临床试验将成为成功的关键。
您认为药物治疗在冠脉介入的作用是怎样的?
最佳药物治疗一直是患者治疗的特点,介入操作必须辅以最佳药物治疗来达到最佳效果。这已经在以往多个试验中得到证实。冠脉疾病患者进行 PCI术必须接受药物治疗来控制一切危险因素例如高血压、糖尿病和高脂血症以改善预后。因此,药物治疗对冠脉介入治疗很重要。
第二届临床研究专题研讨峰会给您的印象有哪些?
今年三月份我荣幸地参加了 CIT会议期间举行的第二届临床研究专题研讨峰会,这是一个临床研究与生物统计学的综合课程。来自中国及其他国家的世界闻名专家对一些关键性的问题与观众进行探讨,展开卓越的临床试验 A-Z知识方面的对话。我期待并相信第三届峰会在 2011年CIT期间成功地召开。
CCheart: What are your perspectives about future directions of clinical trials?
Dr. Roxana Mehran: Clinical trials will have a much more global form in the future. The trials must enroll patients from around the globe to further enhance our understanding of outcome of patients from different regions of the world. This will enhance the quality and efficiency of clinical trials in the future. Furthermore, the questions for trials to answer will and must be more patients focused rather than devices or pharma focused. This will engage a multidisciplinary approach to treatment of heart disease with the mission to improve outcomes in patients.
CCheart: What are your recommendations on the development of clinical studies in China?
Dr. Roxana Mehran: China is already on its way for conducting clinical trials. The devotion to high quality work in an environment dedicated to scientific integrity, patient care and efficiency will be the ultimate keys to success.
CCheart: What do you think about the roles of medical therapy in coronary interventions?
Dr. Roxana Mehran: Optimal medical therapy has always been the hallmark of patient care. Interventional procedures must be accompanied by optimal medical therapy for its best effect. This has been proven with multiple previous trials. Patients with coronary artery disease undergoing PCI must have medical therapy for control of all risk factors such as hypertension, diabetes and hyperlipidemia for improved outcomes. Therefore medical therapy is seminal in coronary interventions.
CCheart: You have participated in the 2nd clinical research workshops at CIT2010 in China. Could you tell us what impressed you in this workshop?
Dr. Roxana Mehran: I had the honor to attend the 2nd clinical research workshops at the CIT conference in March this year. This was a comprehensive course focused on clinical research and basic biostatistics. The world-renowned faculty from China and around the world focused on key discussion points with audience participation and excellent dialogue regarding clinical trials from A-Z. I look forward to the 3rd annual course which promises to be a success in the upcoming CIT course in 2011.
来源: 医心网



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