VanHelene Alexander David, Hadfield Matthew J, Trapani Dario, Warner Jeremy Lyle, Lythgoe Mark P
Hematology and Oncology, Rhode Island Hospital, Providence, Rhode Island, USA.
Legorreta Cancer Center, Brown University, Providence, Rhode Island, USA.
BMJ Oncol. 2024 Aug 14;3(1):e000410. doi: 10.1136/bmjonc-2024-000410. eCollection 2024.
The UK's withdrawal from the European Union (a political movement known as 'Brexit') incited concern both in the public and private sector about the future of drug development and the clinical trial landscape in the UK. This study evaluates trends in the initiation of phase III clinical trials that evaluated systemic anticancer treatments from 2010 to 2022 both in the UK and worldwide.
Relevant clinical trials were identified through ClinicalTrials.gov. Initiation date in each country was defined as the date that a study's record was updated to include a recruiting site in the country of interest. Concurrent clinical site counts were defined as the number of facilities that contemporaneously hosted trials. Temporal trends in trial initiation and site counts were evaluated.
Our analysis uncovered a worldwide increase in clinical trial initiation from 2013 to 2019. The UK experienced a decrease in clinical trial initiation immediately post-Brexit in 2020 but rebounded in 2021. The UK's resurgence in clinical trials in 2021 was driven predominately by industry-funded trials. Other countries saw a similar increase in clinical trial initiation from 2020 to 2021.
The UK's trends in phase III oncology clinical trial initiation from 2010 to 2022 largely reflects global trends, suggesting that other factors (eg, COVID-19 pandemic) beyond Brexit, may have had a stronger influence on clinical trial initiation within the UK.
英国脱欧(一项被称为“英国退欧”的政治运动)引发了公共和私营部门对英国药物研发及临床试验前景的担忧。本研究评估了2010年至2022年期间英国和全球范围内启动的评估全身抗癌治疗的III期临床试验的趋势。
通过ClinicalTrials.gov确定相关临床试验。每个国家的启动日期定义为研究记录更新以纳入感兴趣国家的招募地点的日期。同期临床地点计数定义为同时开展试验的设施数量。评估了试验启动和地点计数的时间趋势。
我们的分析发现,2013年至2019年全球范围内临床试验启动数量有所增加。英国在2020年脱欧后立即出现临床试验启动数量下降,但在2021年有所反弹。英国2021年临床试验的复苏主要由行业资助的试验推动。其他国家在2020年至2021年期间临床试验启动数量也有类似增加。
2010年至2022年期间英国III期肿瘤临床试验启动趋势在很大程度上反映了全球趋势,这表明除英国脱欧之外的其他因素(如新冠疫情)可能对英国境内的临床试验启动产生了更强的影响。