Asfand Baig Mirza, Feras Fayez, Sami Rashed, Layla Burn, Zachariah M Evans, Zekiye Karagozlu, Amisha Vastani, Jose Pedro Lavrador, Francesco Vergani, Richard Gullan, Ranjeev Bhangoo, Keyoumars Ashkan
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引用次数: 0
Abstract
Purpose: This study systematically reviews and meta-analyses the extent of ethnic minority representation in neuro-oncology Phase III and IV clinical trials, explores the effect of ethnicity on outcomes, and identifies predictors for the inclusion of ethnicity data in publications.
Methods: Adhering to PRISMA guidelines, we conducted a comprehensive literature search across multiple databases, on Phase III and IV trials in neuro-oncology that reported on adult and/or paediatric subjects. Through meta-analysis, we synthesized information on overall survival, event-free survival, and the incidence of adverse outcomes across ethnicities.
Results: From 448 identified articles, a fraction reported ethnicity data, with an even smaller number providing outcome data stratified by ethnicity. Most study participants were identified as White, underscoring a significant underrepresentation of minorities. Our meta-analysis did not reveal significant outcome differences by ethnicity, which may be attributed to the limited and inadequate reporting of data. Predictors for including ethnicity data were identified, including trials in North America(OR2.39, 95%CI 1.18-5.12, p < 0.02),trials of drugs or biologic agents(OR 5.28, 95%CI 1.43-3.42, p < 0.05),and trials funded by charities(OR 2.28, 95% CI 1.04-5.27, p < 0.05) or pharmaceutical companies(OR 3.98, 95% CI 1.60-10.0, p < 0.005).
Conclusion: The underrepresentation of minorities in neuro-oncology clinical trials and the inadequately characterized impact of ethnicity on treatment outcomes highlight a critical need for more inclusive recruitment strategies and improved reporting standards. Change is necessary to ensure trials reflect the diversity of the patient population, which is essential for developing tailored strategies and improving outcomes. Future research should prioritize understanding the role of ethnicity in neuro-oncology to facilitate personalized treatment approaches.
目的:本研究系统回顾和荟萃分析了神经肿瘤学 III 期和 IV 期临床试验中少数民族的代表程度,探讨了种族对结果的影响,并确定了在出版物中纳入种族数据的预测因素:根据 PRISMA 指南,我们在多个数据库中对神经肿瘤学 III 期和 IV 期临床试验进行了全面的文献检索,这些试验报告的对象包括成人和/或儿科受试者。通过荟萃分析,我们综合了不同种族的总生存率、无事件生存率和不良反应发生率等信息:在 448 篇已确定的文章中,只有一小部分报告了种族数据,而提供按种族分层的结果数据的文章数量更少。大多数研究参与者被认定为白人,这表明少数族裔的代表性明显不足。我们的荟萃分析没有发现不同种族的结果有显著差异,这可能是由于数据报告有限和不充分造成的。我们确定了纳入种族数据的预测因素,其中包括北美的试验(OR2.39,95%CI 1.18-5.12,p 结论):少数民族在神经肿瘤临床试验中的代表性不足,以及种族对治疗结果影响的描述不充分,都凸显出我们亟需制定更具包容性的招募策略并改进报告标准。要确保试验反映患者群体的多样性,就必须做出改变,这对制定有针对性的策略和改善疗效至关重要。未来的研究应优先考虑了解种族在神经肿瘤学中的作用,以促进个性化的治疗方法。
期刊介绍:
The Journal of Neuro-Oncology is a multi-disciplinary journal encompassing basic, applied, and clinical investigations in all research areas as they relate to cancer and the central nervous system. It provides a single forum for communication among neurologists, neurosurgeons, radiotherapists, medical oncologists, neuropathologists, neurodiagnosticians, and laboratory-based oncologists conducting relevant research. The Journal of Neuro-Oncology does not seek to isolate the field, but rather to focus the efforts of many disciplines in one publication through a format which pulls together these diverse interests. More than any other field of oncology, cancer of the central nervous system requires multi-disciplinary approaches. To alleviate having to scan dozens of journals of cell biology, pathology, laboratory and clinical endeavours, JNO is a periodical in which current, high-quality, relevant research in all aspects of neuro-oncology may be found.