Van de Vliet Peter, Sprenger Tobias, Kampers Linde F C, Makalowski Jennifer, Schirrmacher Volker, Stücker Wilfried, Van Gool Stefaan W
Immune-Oncological Centre Cologne (IOZK), D-50674 Cologne, Germany.
Biomedicines. 2023 Jun 23;11(7):1793. doi: 10.3390/biomedicines11071793.
The fundamental aim of healthcare is to improve overall health of the population by providing state-of-the-art healthcare for individuals at an affordable cost. The foundation for this system is largely referred to as "evidence-based medicine". Too often, evidence-based medicine is based solely on so-called "best research evidence", collected through randomized controlled trials while disregarding clinical expertise and patient expectations. As healthcare gravitates towards personalized and individualized medicine, such external clinical (research) evidence can inform, but never replace, individual clinical expertise. This applies in particular to orphan diseases, for which clinical trials are methodologically particularly problematic, and evidence derived from them is often questionable. Evidence-based medicine constitutes a complex process to allow doctors and patients to select the best possible solutions for each individual based on rapidly developing new therapeutic directions. This requires a revisit of the foundations of evidence-based medicine. A proposition as to how to manage evidence-based data in individualized immune-oncology is presented here.
医疗保健的根本目标是通过以可承受的成本为个人提供最先进的医疗保健服务来改善总体人群的健康状况。这个体系的基础在很大程度上被称为“循证医学”。循证医学常常仅仅基于通过随机对照试验收集的所谓“最佳研究证据”，却忽视了临床专业知识和患者期望。随着医疗保健朝着个性化和个体化医疗发展，此类外部临床（研究）证据可以提供参考，但绝不能取代个人临床专业知识。这尤其适用于罕见病，对于罕见病而言，临床试验在方法上特别成问题，并且从中得出的证据往往存疑。循证医学是一个复杂的过程，旨在让医生和患者根据快速发展的新治疗方向为每个个体选择最佳可能的解决方案。这需要重新审视循证医学的基础。本文提出了一个关于如何在个体化免疫肿瘤学中管理循证数据的主张。
