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首页> 外文期刊>Journal of comparative effectiveness research >Building useful evidence: changing the clinical research paradigm to account for comparative effectiveness research
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Building useful evidence: changing the clinical research paradigm to account for comparative effectiveness research

机译：建立有用的证据：改变临床研究范式以考虑比较有效性研究

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Comparative effectiveness research (CER) calls for substantial changes in the way clinical research is conducted, interpreted and practically applied in the USA, in orderto produce useful clinical evidence. Departing from classic efficacy and effectiveness research, the evolving CER paradigm requires structural and substantive innovations that address three basic questions: what works? for whom? and in whose hands? Addressing these questions will require fundamental changes in the approach to clinical research that include: the use of active treatments (or comparators) versus placebos in the comparisons of treatments, innovative or 'alternative' research methods, the specification and a priori design of studies to account for important subgroups, accounting for the nested nature of healthcare delivery in design and analysis of CER, the simultaneous study of multiple treatments or treatment modalities, the study of multiple outcomes (benefits and harms) for each treatment compared, and the reassessment of the value of different study designs in the hierarchy of collective'evidence'. In order to aid individual providers and patients in making informed, personalized treatment decisions, guided by the best evidence possible, CER studies must generalize to a broad range of subgroups reflecting the spectrum of patients, providers and health systemsthat populate real-world practice settings. Without expansion in the scope, conduct and subsequent interpretation of clinical research reflected in the issues outlined above, CER will fall short of its potential for informing evidence-based practice and personalized medicine. The current paradigm for conducting, interpreting and applying clinical research does not meet the needs of optimal generalizability and application to individual physician-patient efforts to identify the most effective treatment, and therefore does not support the basic requirements of CER. The proposed changes should neither require decades nor exorbitant budgets to achieve. Using two examples, prostate cancer, and comparisons of single medications, we illustrated how the proposed changes in clinical research, matching strategy to each application, might be addressed.
机译：比较有效性研究（CER）要求在美国进行，解释和实际应用临床研究的方式发生重大变化，以便产生有用的临床证据。与经典的功效和功效研究不同，不断发展的CER范式需要结构性和实质性创新，以解决三个基本问题：什么有效？为了谁？在谁的手中？解决这些问题将需要对临床研究方法进行根本性的改变，包括：在比较治疗方法，创新或“替代”研究方法，研究的规范和先验设计中使用主动治疗（或比较剂）与安慰剂的比较。占重要的亚组，在CER的设计和分析中考虑医疗服务的嵌套性质，同时研究多种疗法或治疗方式，比较每种疗法的多种结果（益处和危害），并重新评估集体“证据”层次中不同研究设计的价值。为了在可能的最佳证据的指导下帮助个体提供者和患者做出明智的个性化治疗决策，CER研究必须推广到反映患者，提供者和卫生系统范围的广泛亚组，这些患者，提供者和卫生系统构成了实际操作环境。如果不扩大上述问题所反映的临床研究的范围，行为和后续解释，CER将无法为循证实践和个性化医学提供信息。当前进行，解释和应用临床研究的范式不能满足最佳概括性的要求，也无法满足医患个体确定最有效治疗方法的需求，因此不支持CER的基本要求。拟议的变更既不需要数十年的预算，也不需要过多的预算。通过两个例子，前列腺癌和单一药物的比较，我们说明了如何解决临床研究中提出的变化以及与每种应用的匹配策略。

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