Sader Helio S, Rhomberg Paul R, Fuhrmeister Andrew S, Mendes Rodrigo E, Flamm Robert K, Jones Ronald N
JMI Laboratories, North Liberty, Iowa.
Open Forum Infect Dis. 2019 Mar 15;6(Suppl 1):S5-S13. doi: 10.1093/ofid/ofy345. eCollection 2019 Mar.
Surveillance represents an important informational tool for planning actions to monitor emerging antimicrobial resistance. Antimicrobial resistance surveillance (ARS) programs may have many different designs and can be grouped in 2 major categories based on their main objectives: (1) public health ARS programs and (2) industry-sponsored/product-oriented ARS programs. In general, public health ARS programs predominantly focus on health care and infection control, whereas industry ARS programs focus on an investigational or recently approved molecule(s). We reviewed the main characteristics of industry ARS programs and how these programs contribute to new drug development. Industry ARS programs are generally performed to comply with requirements from regulatory agencies responsible for commercial approval of antimicrobial agents, such as the US Food and Drug Administration, European Medicines Agency, and others. In contrast to public health ARS programs, which typically collect health care and diverse clinical data, industry ARS programs frequently collect the pathogens and perform the testing in a central laboratory setting. Global ARS programs with centralized testing play an important role in new antibacterial and antifungal drug development by providing information on the emergence and dissemination of resistant organisms, clones, and resistance determinants. Organisms collected by large ARS programs are extremely valuable to evaluate the potential of new agents and to calibrate susceptibility tests once a drug is approved for clinical use. These programs also can provide early evaluations of spectrum of activity and postmarketing trends required by regulatory agencies, and the programs may help drug companies to select appropriate dosing regimens and the appropriate geographic regions in which to perform clinical trials. Furthermore, these surveillance programs provide useful information on the potency and spectrum of new antimicrobial agents against indications and organisms in which clinicians have little or no experience. In summary, large ARS programs, such as the SENTRY Antimicrobial Surveillance Program, contribute key data for new drug development.
监测是规划监测新出现的抗菌药物耐药性行动的重要信息工具。抗菌药物耐药性监测（ARS）项目可能有许多不同的设计，并可根据其主要目标分为两大类：（1）公共卫生ARS项目和（2）行业赞助/产品导向的ARS项目。一般来说，公共卫生ARS项目主要关注医疗保健和感染控制，而行业ARS项目则关注研究性或最近批准的分子。我们回顾了行业ARS项目的主要特点以及这些项目如何为新药开发做出贡献。行业ARS项目通常是为了符合负责抗菌药物商业批准的监管机构的要求而开展的，如美国食品药品监督管理局、欧洲药品管理局等。与通常收集医疗保健和各种临床数据的公共卫生ARS项目不同，行业ARS项目经常收集病原体并在中央实验室环境中进行检测。集中检测的全球ARS项目通过提供有关耐药生物体、克隆和耐药决定因素的出现和传播的信息，在新型抗菌和抗真菌药物开发中发挥着重要作用。大型ARS项目收集的生物体对于评估新药的潜力以及在药物获批临床使用后校准药敏试验极为有价值。这些项目还可以提供监管机构要求的活性谱早期评估和上市后趋势，并且这些项目可能有助于制药公司选择合适的给药方案以及进行临床试验的合适地理区域。此外，这些监测项目提供了有关新型抗菌药物针对临床医生经验很少或没有经验的适应症和生物体的效力和活性谱的有用信息。总之，大型ARS项目，如哨兵抗菌监测项目，为新药开发贡献了关键数据。
