抗肿瘤药物临床试验中的受试者管理

2018-12-12 MedSci MedSci原创

随着肿瘤诊断技术的提高,发病机制的深入探讨以及新的靶向治疗及免疫治疗方法的快速发展,肿瘤临床试验也取得了飞速发展。国际、国内的政策法规也对临床试验整体的质量提出了更高要求,其中重中之重是受试者的管理。由于肿瘤临床试验的复杂性及特殊性,对于受试者的管理有些特殊要求,笔者将结合自己的工作经验探讨一下肿瘤临床试验受试者的管理。 研究者对受试者的管理 1 知情同意的过程 《药物临床试验质量管

随着肿瘤诊断技术的提高,发病机制的深入探讨以及新的靶向治疗及免疫治疗方法的快速发展,肿瘤临床试验也取得了飞速发展。国际、国内的政策法规也对临床试验整体的质量提出了更高要求,其中重中之重是受试者的管理。由于肿瘤临床试验的复杂性及特殊性,对于受试者的管理有些特殊要求,笔者将结合自己的工作经验探讨一下肿瘤临床试验受试者的管理。 研究者对受试者的管理 1 知情同意的过程 《药物临床试验质量管理规范》第五章明确说明研究者应向受试者说明经伦理委员会同意的有关临床试验的详细情况,并取得知情同意书。这就表明知情同意是个过程,而不是单纯的一份知情同意书。 第一,需要研究医生提供必要的信息,包括试验目的、试验的过程与期限、检查操作、受试者预期可能的受益和风险,告知受试者可能被分配到试验的不同组别,对于肿瘤受试者还需要介绍疾病的诊断、分型分期、目前的标准治疗等。 第二,需要受试者及其家属充分理解,他们在接受基本信息的基础上,阅读知情同意书,提出质疑,研究医生进行解答,如果受试者及家属仍然需要进一步查询相关资料、征求家里其他成员的意见,允许其将知情同意书带回家。 第三,受试者要完全自愿参加临床试验,而且有权在

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Nat Med:科研人员发现新免疫抑制细胞影响抗肿瘤免疫应答

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Apoptosis:技术生物所在高丝氨酸内脂抗肿瘤机制研究方面取得进展

近期,中国科学院合肥物质科学研究院技术生物与农业工程研究所赵国平、许安课题组在高丝氨酸内脂诱导活体细胞的凋亡及其抗肿瘤机制方面取得进展。研究发现高丝氨酸内酯(C12)在活体水平时,通过诱导线粒体依赖的氧化应激,以及激活DNA损伤和p38/JNK MAPK信号,发挥促凋亡和抗肿瘤作用。

Eur Respir J:低分子肝素在肺癌患者中有抗肿瘤效果吗?

由此可见,对于完全切除的I-IIIA期NSCLC患者,辅助性亭扎肝素治疗对总体和无复发生存率没有明显的影响。这些结果不支持LMWH作为抗肿瘤剂进行进一步临床评估。