BMJ:2014-16年间EMA批准抗肿瘤药物临床关键试验偏倚风险研究

2019-09-23 MedSci MedSci原创

研究认为,2014年至2016年间, EMA批准的新癌症药物所基于的关键研究中,近一半存在很高的偏见风险

近日研究人员审查欧洲药品管理局(EMA)批准的癌症药物关键随机对照试验的设计特点、偏差风险和报告充分性。

本次研究为横截面分析,考察2014年至2016年间,EMA批准的癌症新药的关键随机对照试验。研究临床设计特点(随机化、比较和终点);使用经修订的Cochrane工具评估偏差风险(随机化过程产生的偏见、偏离预期干预措施、缺失的结果数据、结果的衡量和报告结果的选择)以及报告的充分性(试验规程、出版物、补充附录、临床试验登记记录和管理文件中信息的完整性和一致性)。

2014年至2016年,EMA在54项关键研究的基础上批准了32种新的癌症药物,其中41例(76%)为随机对照试验,13例(24%)为非随机研究或单臂研究。39/41随机对照试验有可用的出版物,并包括在研究中。只有10项随机对照试验(26%)将总的生存率测量为主要或共同终点,其余的试验评估替代措施,如无进展生存率和应答率。总的来说,19项随机对照试验(49%)被认为对其主要结果有很高的偏见风险。对缺失结果数据(n=10)和对结果测量(n=7)关注是导致偏见判断的高风险的最常见领域,但将总生存率作为主要终点的随机对照试验的偏见风险少于那些评价替代疗效终点的随机对照试验分别为2/10(20%)vs 16/29(55%)。当监管文件和科学文献中的信息被分开考虑时,8个随机对照试验(21%)的偏倚判断总体风险不同,这反映了两种信息来源差异。监管机构发现了10种药物的偏差评估风险范围以外的额外缺陷(31%)。这些缺陷包括临床收益的大小、不适当的比较和非首选的研究终点。

研究认为,2014年至2016年间, EMA批准的新癌症药物所基于的关键研究中,近一半存在很高的偏见风险。

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    2020-04-22 gaoxiaoe
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    2019-09-25 fengyi812
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