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首页> 外文期刊>Italian Journal of Public Health >Clinical use, safety and effectiveness of novel high cost anticancer therapies after marketing approval: a record linkage study
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Clinical use, safety and effectiveness of novel high cost anticancer therapies after marketing approval: a record linkage study

机译：市场批准后，新型高成本抗癌疗法的临床使用，安全性和有效性：一项记录关联研究

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Background: major clinical outcomes of anticancer drugs may differ between clinical trials and clinical practice. Administrative databases provide long-term information on safety and effectiveness of these drugs in large unselected populations and in selected subgroups of patients. In addition, these data provide complementary information on topics where evidence from randomized clinical trials is unavailable. Methods: this project will investigate 17 new targeted high cost drugs in Lombardy oncology practice between 2006 and 2010 using data from electronic healthcare databases. Specific objectives are: 1) to estimate the incidence of serious adverse events in clinical practice and their predictors; 2) to estimate survival and progression free survival and their predictors; 3) to compare major clinical outcomes according to different regimen of therapy. We will build a database by record linkage of several regional health service sources: the File F registry (in which the administration of the 17 drugs is recorded), the Regional hospital discharge forms (SDO ) database, the drug prescription database, the outpatients' services database, and the Registry Office database. Subjects resident in Lombardy who received at least one prescription of these drugs from 2006 to 2010 will be considered. Complications warranting hospitalization will be derived from the patients' SDO s after the first drug administration. Vital status will be obtained from the Registry Office database. Results: we will provide estimates of the incidence of serious adverse events of novel anticancer therapies, and of overall and disease free survival in clinical practice, overall and in selected subgroups. Conclusions: these data will contribute to a better effectiveness evaluation, particularly in patients under-represented in clinical trials.
机译：背景：抗癌药物的主要临床结果在临床试验和临床实践之间可能有所不同。行政数据库提供了有关这些药物在未选定人群中和选定患者亚组中的安全性和有效性的长期信息。此外，这些数据提供了关于主题的补充信息，而这些主题尚无来自随机临床试验的证据。方法：该项目将使用电子医疗数据库中的数据，在2006年至2010年之间调查伦巴第肿瘤学实践中的17种新型靶向高成本药物。具体目标是：1）估计临床实践中严重不良事件的发生率及其预测因素; 2）估计生存和无进展生存期及其预测因子; 3）根据不同的治疗方案比较主要的临床结果。我们将通过记录多个区域卫生服务源的链接来建立数据库：文件F注册表（记录了17种药物的管理记录），区域医院出院表格（SDO）数据库，药物处方数据库，门诊病人服务数据库和注册处数据库。在2006年至2010年期间，至少在伦巴第居住的受试者接受了至少一张这些药物的处方。首次住院后，需要住院的并发症将来自患者的SDO。重要身份将从注册表办公室数据库中获取。结果：我们将提供有关新型抗癌疗法严重不良事件发生率的估计值，以及在临床实践，总体和选定亚组中总体生存率和无病生存率的估计值。结论：这些数据将有助于更好的有效性评估，尤其是在临床试验中代表性不足的患者中。

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