Variation in Accrual and Race/Ethnicity Reporting in Urological and Nonurological Related Cancer Trials
Variation in Accrual and Race/Ethnicity Reporting in Urological and Nonurological Related Cancer Trials
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DOI：
10.1097/ju.0000000000000294
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发表时间：
2019-08-01
影响因子：
6.6
通讯作者：
Konety, Badrinath R.
中科院分区：
文献类型：
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作者：
Paul, Koushik;Sathianathen, Niranjan;Konety, Badrinath R.
目的：我们进行了一项多注册分析，以评估常见泌尿系统癌症和其他非泌尿系统实体器官肿瘤试验中累积充分性和种族/民族报告的相对差异。材料和方法：我们查询了ClinicalTrials.gov和ISRCTN（国际标准随机对照试验编号）注册中心的III期和IV期临床试验，主要集中在前列腺癌、结直肠癌、肾癌、膀胱癌、睾丸癌、乳腺癌和肺癌。已确定的试验用适当的已发表的数据来源进行交叉验证。计算了种族/族裔报告的相对应计充分性和比率。进行多变量logistic回归分析以确定与累计状态和种族/民族报告相关的因素。结果：根据我们预先指定的标准，共确定了326项试验，其中63%报告了截止时间的足够累积，58%报告了种族/民族数据。非泌尿系统试验比泌尿系统试验更有可能提到种族数据（OR 3.25, 95% CI 1.24-8.55, p = 0.02）。行业赞助的试验比政府资助的项目更有可能达到应计目标（OR 5.44, 95% CI 1.64-18.20, p = 0.001）。尽管资金来源不影响种族报告，但据报道，在工业赞助的试验中，非洲裔参与者的招募较少（11.49% vs 3.18%, p < 0.01）。三分之二的研究没有报告非裔美国人种族/民族的基线特征。结论：不充分的累积和不充分的种族/民族报告是普遍存在的问题，限制了对主要实体器官恶性肿瘤临床试验结果的解释。解决这些缺点将通过提高统计能力和提高报告的透明度来提高结果的有效性，从而更好地评价结果的普遍性。
Purpose: We performed a multiregistry analysis to assess relative differences in accrual sufficiency and race/ethnicity reporting in trials of common urological cancers and other nonurological solid organ tumors.Materials and Methods: We queried ClinicalTrials.gov and the ISRCTN (International Standard Randomised Controlled Trial Number) Registry for closed phase III and IV trials focused on prostate, colorectal, kidney, bladder, testicular, breast and lung cancer. Identified trials were cross-verified with appropriate published data sources. Comparative accrual sufficiency and rates of race/ethnicity reporting were calculated. Multivariable logistic regression analysis was performed to determine factors associated with accrual status and race/ethnicity reporting.Results: A total of 326 trials were identified based on our prespecified criteria, of which 63% reported sufficient accrual by time of closure and 58% reported data by race/ethnicity. Nonurological trials were significantly more likely to mention race data than urological trials (OR 3.25, 95% CI 1.24-8.55, p = 0.02). Industry sponsored trials were more likely to meet accrual targets than government funded projects (OR 5.44, 95% CI 1.64-18.20, p = 0.001). Although funding source did not influence race reporting, the reported recruitment of participants of African ethnicity was lower in industry sponsored trials (11.49% vs 3.18%, p < 0.01). Two-thirds of the studies did not report baseline characteristics by African American race/ethnicity.Conclusions: Insufficient accrual and inadequate race/ethnicity reporting are prevalent issues, limiting interpretation of the results of clinical trials of major solid organ malignancies. Addressing these shortcomings would enhance result validity by raising statistical power and improving the transparency of reporting to better evaluate the generalizability of results.