Cooper Lisa, Lee Irene, Waldron Lechner Doreen
Department of Health Informatics, School of Health Professions, Rutgers, The State University of New Jersey, Newark, NJ, USA.
Ernest Mario School of Pharmacy, Rutgers, The State University of New Jersey, Piscataway, NJ, USA.
J Clin Transl Sci. 2021 Mar 16;5(1):e111. doi: 10.1017/cts.2021.25.
The COVID-19 pandemic has impacted millions of lives globally. To learn more about this disease and find potential diagnostic, therapeutic, and preventative products, the healthcare community has initiated a staggering number of clinical trials.
ClinicalTrials.gov was reviewed to determine if trial sponsor type had a relationship to time to COVID-19 response, which was defined as the date from disease discovery in Wuhan, China to ClinicalTrials.gov study "First Posted" date.
A total of 673 United States (US) sponsored, interventional study listings were retrieved, of which 293 (43.5%) were Industry-sponsored, 349 (51.9%) were Academic sponsored, and 31 (4.6%) were Other sponsor types. Of the Academic studies, 181 (51.9%) were Clinical and Translational Science Award (CTSA) hubs. The average response time for all sponsor types was 189 days, with Academic sponsors having the shortest average response time of 172.6 days ( < 0.001). CTSA hubs had a significantly ( < 0.001) shorter average response time (168.1 days) compared to all other sponsor types (197.4 days). However, while shorter in duration by 9.4 days, response time was not significantly different from non-CTSA sponsors (177.5 days; = 0.238). Additionally, ANOVA indicated significant relationships ( < 0.001) between funding type, study phase, number of sites, and enrollment size on response time.
Studies posted with the shortest response time were Academic-sponsored trials and included smaller sized investigations of repurposed approved or investigational drugs for the treatment of COVID-19 symptoms. A small second wave of study postings occurred approximately 4 months later, and included small, unique therapies targeting prevention or treatment of COVID-19.
新冠疫情已在全球范围内影响了数百万人的生活。为了更多地了解这种疾病并寻找潜在的诊断、治疗和预防产品,医疗界发起了数量惊人的临床试验。
对ClinicalTrials.gov进行审查,以确定试验主办方类型与新冠疫情应对时间之间是否存在关联,新冠疫情应对时间定义为从中国武汉发现该疾病之日到ClinicalTrials.gov研究“首次发布”日期。
共检索到673项由美国主办的干预性研究列表,其中293项(43.5%)由行业赞助,349项(51.9%)由学术机构赞助,31项(4.6%)为其他主办方类型。在学术研究中,181项(51.9%)是临床与转化科学奖(CTSA)中心。所有主办方类型的平均应对时间为189天,学术主办方的平均应对时间最短,为172.6天(<0.001)。与所有其他主办方类型(197.4天)相比,CTSA中心的平均应对时间显著更短(<0.001)(168.1天)。然而,尽管持续时间短9.4天,但应对时间与非CTSA主办方(177.5天;P = 0.238)并无显著差异。此外,方差分析表明资金类型、研究阶段、研究地点数量和入组规模与应对时间之间存在显著关系(<0.001)。
应对时间最短的研究是由学术机构赞助的试验,包括对用于治疗新冠症状的已批准或研究性药物进行重新利用的规模较小的调查。大约4个月后出现了第二波规模较小的研究发布浪潮,包括针对新冠预防或治疗的小型独特疗法。