Zhao Shanshan, Zaytseva Olga, Chang Xiaohong, Zhang Boquan
Clinical Trial Institution Office/Department of Pharmacy, China Emergency General Hospital, Beijing, 100028, China.
Pharmacology Department, Bashkir State Medical University, Ufa, 450008, Bashkortostan, Russia.
Contemp Clin Trials Commun. 2022 Oct 12;30:101014. doi: 10.1016/j.conctc.2022.101014. eCollection 2022 Dec.
To examine fundamental characteristics of clinical trials with therapeutic drug monitoring (TDM) as intervention on world major clinical trials registry platform.
Cross-sectional analysis of clinical trials with TDM as intervention that were registered on WHO International Clinical Trials Registry Platform (ICTRP) or ClinicalTrials.gov. Relevant trial entries registered before and on March 2nd, 2022 were downloaded, deduplicated, and reviewed. Recruit country, monetary source, start years, study design, medical conditions, involved drugs, outcome measure, and subject information were extracted and analyzed.
Overall, 173 clinical trials were included in this study. Majority of the trials were conducted in several economically prosperous countries. The earliest initiated trials dates back to 2002. Most of the trials were funded by hospitals (36.4%). A higher proportion of trials were conducted within one country (86.1%), as phase Ⅳ (34.1%) interventional study (82.7%), randomized (52.6%), parallel assignment (53.8%) and open label (67.0%). The most concerned medical condition were infectious or parasitic disease and neoplasms, with the most monitored drugs were immunosuppressants and β-lactam antibacterials. Most of the trials enroll no more than 50 subjects (30.6%), with both gender (95.4%), and adults (67.0%).
The trials were mainly conducted in several economically prosperous countries. The number of registered trials had gradually increased during the past years. Novel biological drugs have increasingly become the research hotspot. We expect that with abundant financial support, more high-quality large-scale, multicenter randomized clinical trials (RCTs) are designed and implemented to promote the development of TDM in the future.
在世界主要临床试验注册平台上，研究以治疗药物监测（TDM）作为干预措施的临床试验的基本特征。
对在世界卫生组织国际临床试验注册平台（ICTRP）或美国国立医学图书馆临床试验数据库（ClinicalTrials.gov）上注册的以TDM作为干预措施的临床试验进行横断面分析。下载2022年3月2日前注册的相关试验条目，进行去重和审核。提取并分析招募国家、资金来源、开始年份、研究设计、医疗状况、涉及药物、结局指标和受试者信息。
本研究共纳入173项临床试验。大多数试验在几个经济发达国家进行。最早开展的试验可追溯到2002年。大部分试验由医院资助（36.4%）。较高比例的试验在一个国家内进行（86.1%），为Ⅳ期（34.1%）干预性研究（82.7%），随机化（52.6%）、平行分组（53.8%）和开放标签试验（67.0%）。最受关注的医疗状况是感染性或寄生虫病以及肿瘤，监测最多的药物是免疫抑制剂和β-内酰胺类抗菌药物。大多数试验纳入不超过50名受试者（30.6%），受试者包括男性和女性（95.4%），以成年人为主（67.0%）。
试验主要在几个经济发达国家进行。在过去几年中，注册试验数量逐渐增加。新型生物药物越来越成为研究热点。我们期望在充足的资金支持下，未来能设计并实施更多高质量的大规模、多中心随机临床试验（RCT），以促进TDM的发展。
