“Economic Evaluation of Cancer Drugs Using Clinical Trial and RealWorld Data”

Norman M.Goldfarb

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“Economic Evaluation of Cancer Drugs Using Clinical Trial and RealWorld Data”

机译：“使用临床试验和真实数据对癌症药物进行经济评估”

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“Economic Evaluation of Cancer Drugs Using Clinical Trial and Real-World Data” addresses a critical question in health care: What do we do with treatments that effectively treat lethal diseases but are unaffordable to patients, insurance companies, and even governments? Over time, patents expire and costs slide down the learning curve, but technologies like CAR-T are inherently expensive to produce. Biosimilars have been very slow to reach the market. Treatments for rare diseases are proliferating, but, by definition, have small markets to absorb the cost of development.

机译：“使用临床试验和现实数据对癌症药物进行经济评估”解决了医疗保健中的一个关键问题：我们如何使用有效治疗致命疾病但患者，保险公司甚至政府买不起的疗法？随着时间的流逝，专利到期并且成本下降，但是CAR-T之类的技术天生就很昂贵。生物仿制药进入市场的速度非常缓慢。罕见病的治疗方法正在激增，但从定义上讲，其市场规模很小，无法吸收开发成本。

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《Journal of Clinical Research Best Practices》 |2019年第9期|共2页
作者
Norman M.Goldfarb;
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中图分类临床医学;
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1. Economic Evaluation of Cancer Drugs using Clinical Trial and Real-World Data [J] . Shanmugam Ramalingam Journal of statistical computation and simulation . 2021,第7a9期

机译：临床试验和现实世界数据的癌症药物的经济评价
2. The Value of Observational Cohort Studies for Cancer DrugsRandomized controlled trials - the gold standard for clinical drug evaluation -can't always predict adverse events in real-world settings. For the new cancer therapies, observational cohort studies (OCSs) can help evaluate their effects in broader populations and provide valuable information for future clinical trials. [J] . DAVID R. SPIGEL Biotechnology healthcare . 2010,第2期

机译：观察性队列研究对癌症药物的价值随机对照试验-临床药物评估的金标准-不能总是预测现实世界中的不良事件。对于新的癌症疗法，观察性队列研究（OCS）可以帮助评估它们在更广泛的人群中的作用，并为将来的临床试验提供有价值的信息。
3. TCT-312 4-year Clinical Results of a Randomized trial Evaluating the Absorb Bioresorbable Vascular Scaffold vs. Metallic Drug-eluting Stent in de novo Native Coronary Artery Lesions: Data from the ABSORB Japan Trial [J] . Kengo Tanabe, Ken Kozuma, Takeshi Kimura Journal of the American College of Cardiology . 2018,第13期

机译：TCT-312 4年的一项随机试验的4年临床结果评估吸收生物血管血管支架与金属药物洗脱支架在De Novo Native冠状动脉病变中：来自Absta的数据
4. Clinical studies of SP1049C, a polymer based anthracycline effective against drug resistant tumors. Results of phase II trial and pivotal phase Ⅲ program in upper gastrointestinal cancer indications [C] . Valery Alakhov Controlled Release Society Annual Meeting and Exposition . 2007

机译：SP1049C的临床研究，一种基于聚合物的蒽环类药物可有效抵抗耐药性肿瘤。上消化道癌适应症的II期试验和关键性III期试验结果
5. Clinical predictive value of pre-clinical cancer models: A study of the predictive value of the in vitro cell line, human xenograft and murine allograft pre-clinical cancer models for phase II clinical trials of cytotoxic cancer drugs [D] . Voskoglou-Nomikos, Theodora 2001

机译：临床前癌症模型的临床预测价值：体外细胞系，人异种移植和小鼠同种异体移植临床前癌症模型对细胞毒性癌症药物II期临床试验的预测价值研究
6. Data sharing on request for trials: Open access to economic outcome data will help to bridge the gap between clinical trials and clinical guidelines [O] . Joseph A Ladapo, Yixin Fang, Karina W Davidson, 2015

机译：根据试验要求共享数据：开放获取经济成果数据将有助于弥合临床试验与临床指南之间的鸿沟
7. Long-Term Clinical and Economic Analysis of the Endeavor Drug-Eluting Stent Versus the Driver Bare-Metal Stent 4-Year Results From the ENDEAVOR II Trial (Randomized Controlled Trial to Evaluate the Safety and Efficacy of the Medtronic AVE ABT-578 Eluting Driver Coronary Stent in De Novo Native Coronary Artery Lesions) [O] . Eisenstein Eric L., Wijns William, Fajadet Jean, 2009

机译：ENDEAVOR II试验（随机对照试验评估Medtronic AVE ABT-578洗脱驾驶员冠状动脉的安全性和有效性）的努力药物洗脱支架与驾驶员裸金属支架4年结果的长期临床和经济分析De Novo原生冠状动脉病变支架）

“Economic Evaluation of Cancer Drugs Using Clinical Trial and RealWorld Data”

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