病人们往往并不理解临床药物试验的真正用意
导读 | 临床试验是癌症研究的重要一部分,未来研究者将根据病人的疾病程度来选择性地进行药物检测来改善疾病疗法,但近日来自乌普萨拉大学的研究人员通过研究表示,某些癌症患者或许并不理解临床药物试验的真正目的。 |
临床试验是癌症研究的重要一部分,未来研究者将根据病人的疾病程度来选择性地进行药物检测来改善疾病疗法,但近日来自乌普萨拉大学的研究人员通过研究表示,某些癌症患者或许并不理解临床药物试验的真正目的。
研究者Tove Godskesen在他的博士论文中揭示了为何癌症病人会加入到临床的药物试验中去,并且揭示了关于患者们是否理解他们所进行的试验进行了深入地剖析调查;大部分的病人往往都会被充分告知相关情况,而且病人们会对他们参与试验表示满意,也会推荐别人来加入到试验中;但有一小部分患者,而且这些患者大部分是患病者,他们并不理解参与药物临床试验需要什么东西。
病人们似乎并不太能从临床药物试验中获取利益,但是很多人仍然选择去加入试验,研究者在文章中随机调查了进行I期临床试验的患者,而试验中会招募最多的就是严重患病者;此前有研究表明,病人通常会选择有风险且多种要求疗法的试验,甚至是这些试验治愈疾病的概率较低。
一种新型药物往往可以给予难以治愈的癌症患者带来希望,而病人往往也会抓住这最后一根救命稻草并且也会很愿意去忍受新型试验疗法所带来的诸多不适;很多病人都会感激忽视无微不至的照顾,他们认为这是VIP式的护理,但同时这也是一大难题,即如果患者满怀期望花费了其本身为数不多的生存时间来进行试验,而最终他们却知道这样的试验并不意味着能对其进行治愈或治疗,而是促进了疗法的开发。
这项研究中,研究者还向患者发放了相应的调查问卷,其中包括新型疗法和标准化疗法的对比问卷信息等,调查结果显示,20%的患者并不知道疗法试验副作用相关的信息,而且他们也并不知道如何向试验项目负责人询问这些问题。
这些病人参与临床试验的同一个理由就是他们也希望被治愈,但通常他们只是为后期临床试验的成功开发做了一些贡献而已,65岁及以上的男性患者加入试验只是为了偿还他们曾经得到的帮助,不管是责任感还是因为其家人建议这样做,这些患者都希望新型疗法会有效改善其健康。(转化医学网360zhyx.com)
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Patients don't understand the purpose of clinical drug trials
Clinical trials are an important part of cancer research. Future patients depend on the severely ill to test drugs to improve treatment. But in her dissertation from Uppsala University, Tove Godskesen shows that some of these patients have a limited understanding of the purpose of the studies they enroll in.
On August 28, Tove Godskesen will defend her PhD thesis where she has looked at the reasons why cancer patients participate in clinical drug trials and whether they understand the information they have received. She shows that most patients have been adequately informed, are satisfied with their participation and able to recommend others to enroll in studies. But a small group of the patients, who also are the most ill, that had trouble understanding what participation in a drug trial entails. According to Tove Godskesen this is an ethical dilemma for clinical research that risks diluting the practice of informed consent.
It is not very likely that patients would benefit from participating in a clinical drug trial, but many still choose to enroll. Tove Godskesen has interviewed patients in so called phase-1 clinical trials where a drug is tested on humans for the first time. These studies enroll the most severely ill patients. Previous research has shown that patients often choose a risky and demanding treatment even when there is little chance of cure. Tove Godskesen's research supports these findings. She saw that patients had unrealistic expectations of cure and that they lacked understanding of the purpose of drug trials:
"A new drug can give a patient with incurable cancer a hope for cure. Patients grasp at every last straw and are willing to put up with a lot of discomfort to be part of these studies", says Tove Godskesen.
Many patients appreciate the close relationship with the research nurses. They describe a feeling of receiving VIP-treatment and being well taken care of. But this is also a dilemma: If patients should be able to spend their final days according to their own wishes, it is important that they understand that these studies are not meant to cure individual patients, but designed to promote new knowledge......
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