Wong Bryan, Peng Jenny, Jiang Di Maria, Fizazi Karim, Powles Thomas, James Nick, Sridhar Srikala S
Princess Margaret Cancer Center, Toronto, Ontario, Canada.
Department of Cancer Medicine, Institut Gustave Roussy, University of Paris-Saclay, Villejuif, France.
Clin Genitourin Cancer. 2024 Dec;22(6):102210. doi: 10.1016/j.clgc.2024.102210. Epub 2024 Aug 22.
Clinical trials are categorized as industry sponsored trials (ISTs) or investigator-initiated trials (IITs) based on the source of funding and sponsor of the trial. ISTs are usually run by pharmaceutical companies, and are primarily aimed at developing new drugs that ultimately gain regulatory approval. IITs are developed by academic investigators or cooperative groups, often sparked by a clinical need. Both are vital in advancing the field of oncology. To date, little has been published about current trends in ISTs or IITs in genitourinary (GU) oncology. The aim of this study was to assess growth trends of GU oncology ISTs and IITs in 4 countries with similar healthcare infrastructures.
We searched ClinicalTrials.gov for bladder, kidney, and prostate cancer trials conducted in the United States (US), Canada, France, and United Kingdom (UK) from January 2007 to December 2021. Trials were determined to be ISTs or IITs based on their funding source and sponsor. Trials were characterized based on type, purpose, phase, participants, masking, assignment, and allocation.
Overall, 5,834 GU trials were identified, with a balanced distribution of ISTs (n = 3064, n = 52.5%) and IITs (n = 2770, 47.4%). By country, the US conducted the most GU trials (n = 3814) followed by Canada (n = 709), France (n = 677), and the UK (n = 634). Most ISTs were phase 3 trials with over 500 participants while most IITs were open-label phase 2 studies with only 20-49 participants. From 2017 onwards, there was a shift towards more ISTs, most noticeably in Canada and the UK. The COVID-19 pandemic did not have a major impact on the growth of ISTs and IITs.
The gap between ISTs and IITs continues to widen, likely driven by resource and funding challenges faced by investigators. Barriers to completing IITs need to be better understood to promote IIT development and maintain their academically driven intentions.
根据试验的资金来源和主办方，临床试验可分为行业赞助试验（ISTs）或研究者发起的试验（IITs）。ISTs通常由制药公司开展，主要目的是开发最终获得监管批准的新药。IITs由学术研究人员或合作团体开展，通常由临床需求引发。两者对于推动肿瘤学领域的发展都至关重要。迄今为止，关于泌尿生殖系统（GU）肿瘤学中ISTs或IITs的当前趋势，发表的内容很少。本研究的目的是评估在4个拥有相似医疗保健基础设施的国家中，GU肿瘤学ISTs和IITs的增长趋势。
我们在ClinicalTrials.gov上搜索了2007年1月至2021年12月在美国、加拿大、法国和英国进行的膀胱癌、肾癌和前列腺癌试验。根据试验的资金来源和主办方确定其为ISTs或IITs。根据试验类型、目的、阶段、参与者、盲法、分配和随机化进行特征描述。
总体而言，共识别出5834项GU试验，ISTs（n = 3064，占52.5%）和IITs（n = 2770，占47.4%）分布均衡。按国家来看，美国开展的GU试验最多（n = 3814），其次是加拿大（n = 709）、法国（n = 677）和英国（n = 634）。大多数ISTs是3期试验，参与者超过500人，而大多数IITs是开放标签的2期研究，参与者仅20 - 49人。从2017年起，出现了向更多ISTs转变的趋势，在加拿大和英国最为明显。COVID - 19大流行对ISTs和IITs的增长没有重大影响。
ISTs和IITs之间的差距持续扩大，可能是由研究人员面临的资源和资金挑战所驱动。需要更好地理解完成IITs的障碍，以促进IITs的发展并保持其学术驱动的初衷。
