行业合作对美国食品和药物管理局批准泌尿生殖系统恶性肿瘤III期临床试验成功的影响。

IF 4.6 3区 医学 Q1 ONCOLOGY
Kamil Malshy, Matthew Steidle, Trevor C Hunt, Zijing Cheng, Ashley Li, Timothy D Campbell, Jathin Bandari
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引用次数: 0

摘要

目的:试验发起人之间的合作可以汇集专业知识和资源,可能加速药物开发和监管成功。本研究评估了药物赞助商之间的合作是否会影响美国食品和药物管理局(FDA)批准生殖泌尿系统癌III期临床试验的可能性和时机。方法:我们在ClinicalTrials.gov网站上查询了2010年1月1日至2024年10月1日期间完成的所有行业资助的、针对泌尿生殖系统恶性肿瘤的介入性III期试验。包括支持性药物、非治疗性药物或生物等效性研究的试验被排除在外。符合条件的试验按赞助结构分组:单赞助者(SS)或赞助者-合作者(S-C)。通过Kaplan-Meier估计和log-rank检验比较获得FDA批准的时间。分层Cox回归评估跨亚组(疾病部位、分期和既往药物批准)合作的影响。另一项分析检查了满足其主要终点的试验。结果:最初的183项试验中有78项符合纳入标准。其中,51例(65.4%)为SS试验,27例(34.6%)为S-C试验。27项S-C试验中有20项获得FDA批准(74.1%),而51项SS试验中有20项获得FDA批准(39.2%)。S-C试验的批准速度明显更快(风险比[HR], 2.75 [95% CI, 1.46至5.18];P = .0009)。S-C 1年和2年的批准率分别为50.0%和73.6%,而SS试验的批准率分别为19.6%和31.4%。亚组分析证实,转移性疾病、前列腺癌和先前批准的药物均有一致的益处。在达到主要终点的50项试验中,S-C试验具有更高的批准可能性(HR, 2.23 [95% CI, 1.13至4.38];P = .013)。结论:赞助商合作显著提高了III期生殖泌尿系统癌试验的FDA批准率和时间表,包括那些达到主要终点的试验。这一策略可能会提高试验的成功率,并加速获得新疗法。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Impact of Industry Collaboration on US Food and Drug Administration Approval Success in Genitourinary Malignancy Phase III Clinical Trials.

Purpose: Collaboration among trial sponsors can pool expertise and resources, potentially accelerating drug development and regulatory success. This study assessed whether collaborations between drug sponsors influence the likelihood and timing of US Food and Drug Administration (FDA) approval for phase III clinical trials in genitourinary cancers.

Methods: We queried ClinicalTrials.gov for all industry-sponsored, interventional phase III trials in genitourinary malignancies completed between January 1, 2010, and October 1, 2024. Trials involving supportive agents, nontherapeutics, or bioequivalence studies were excluded. Eligible trials were grouped by sponsorship structure: single-sponsor (SS) or sponsor-collaborator (S-C). Time to FDA approval was compared using Kaplan-Meier estimates and log-rank tests. Stratified Cox regression assessed the impact of collaboration across subgroups (disease site, stage, and previous drug approval). An additional analysis examined trials that met their primary end points.

Results: Seventy-eight trials met inclusion criteria from an initial 183. Of these, 51 (65.4%) were SS trials and 27 (34.6%) were S-C. FDA approval was granted for 20 of 27 S-C trials (74.1%) versus 20 of 51 SS trials (39.2%). S-C trials had significantly faster approval (hazard ratio [HR], 2.75 [95% CI, 1.46 to 5.18]; P = .0009). One- and 2-year approval rates were, respectively, 50.0% and 73.6% for S-C, compared with 19.6% and 31.4% for SS trials. Subgroup analyses confirmed consistent benefits across metastatic disease, prostate cancer, and previously approved drugs. Among the 50 trials that met their primary end points, S-C trials had a higher approval likelihood (HR, 2.23 [95% CI, 1.13 to 4.38]; P = .013).

Conclusion: Sponsor collaboration significantly improves FDA approval rates and timelines in phase III genitourinary cancer trials, including those meeting primary end points. This strategy may enhance trial success and accelerate access to new therapies.

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CiteScore
6.40
自引率
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