Powers John H, O'Connell Robert J
Clinical Research Directorate, Frederick National Laboratory for Cancer Research, Frederick, MD, USA.
George Washington University School of Medicine, Washington, DC, USA.
Pharmaceut Med. 2025 Mar;39(2):73-86. doi: 10.1007/s40290-025-00552-3. Epub 2025 Mar 12.
Much infectious disease research focuses on the interaction of microorganisms and drugs in the laboratory, assuming biological activity of inhibiting organism growth in vitro directly translates to improving patient outcomes in the clinic. Yet in vitro testing does not consider the important role of the human immune system in causing and response to disease. Research shows that patient outcomes are still suboptimal even with disease due to organisms that maintain in vitro susceptibility to currently available drugs. Resources and discussions have focused on "antimicrobial resistance" yet the majority of deaths are with susceptible organisms. Studies of new interventions do not address the questions that patients and clinicians in practice ask in order to improve patient outcomes regardless of causative pathogen in patients who would receive the drugs in the real-world setting. Research in infectious diseases should shift to refocus on improving patient outcomes. This would result in changes in the research questions evaluated, the types of patients enrolled, the comparisons made, the interventions studied, the outcomes evaluated, and the types of statistical evaluations used. In turn this would provide patients and clinicians with better evidence for patient care and justify payment for new interventions.
许多传染病研究聚焦于实验室中微生物与药物的相互作用，假定体外抑制生物体生长的生物学活性能直接转化为改善临床患者的治疗效果。然而，体外测试并未考虑人体免疫系统在致病和应对疾病过程中的重要作用。研究表明，即使对于那些对现有药物保持体外敏感性的病原体导致的疾病，患者的治疗效果仍不尽人意。资源和讨论都集中在“抗菌耐药性”上，然而大多数死亡病例是由敏感病原体导致的。新干预措施的研究并未解决患者和临床医生在实际操作中为改善患者治疗效果而提出的问题，无论在现实环境中接受药物治疗的患者感染的是何种病原体。传染病研究应重新聚焦于改善患者治疗效果。这将导致所评估的研究问题、纳入的患者类型、进行的比较、研究的干预措施、评估的结果以及所使用的统计评估类型发生变化。相应地，这将为患者和临床医生提供更好的患者护理证据，并为新干预措施的支付提供依据。
