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Benefit Assessment of Medical Devices of High Risk Classes in Germany: Adaptive Approaches to Balance Early Access and Safety and Efficacy Required?

机译：德国高风险班医疗器械的效益评估：适应性衡量早期访问和安全性和疗效的措施？

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AC Mühlbacher; C Juhnke;
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1. BENEFIT ASSESSMENT OF MEDICAL DEVICES OF HIGH RISK CLASSES IN GERMANY: ADAPTIVE APPROACHES TO BALANCE EARLY ACCESS AND SAFETY AND EFFICACY REQUIRED? [J] . Mhlbacher A. C., Juhnke C., Moerk V Value in health: the journal of the International Society for Pharmacoeconomics and Outcomes Research . 2016,第7期

机译：在德国，对高危人群的医疗设备进行收益评估：是否需要采用早期平衡，安全性和有效性的平衡方法？
2. Analysis of Benefit-risk Balance in Decision-making of the Food and Drug Administration for Premarket Approval of Therapeutic Medical Devices [J] . Yoshihiro MURAGAKI, Miyuki UEMATSU, Hiroshi ISEKI, Advanced Biomedical Engineering . 2013,第2期

机译：食品药品监督管理局治疗性医疗器械上市前批准决策中的利益风险平衡分析
3. Elderly multiple myeloma (MM) patients, who are generally ineligible for transplantation, have high risks of death and treatment discontinuation, and require a regimen incorporating novel agents that balance safety, tolerability, and efficacy. We evaluated alternating bortezomib-dexamethasone and lenalidomide-dexamethasone treatments administered over a 63-day cycle in transplant-ineligible elderly patients with newly diagnosed MM. Subcutaneous bortezomib 1.3 mg/m2 was administered weekly on Days 1, 8, 15, and 22; oral lenalidomide 15 mg daily on Days 36-56; and oral dexamethasone 20 mg on Days 1, 8, 15, 22, 36, 43, 50, and 57 for 6 cycles. The primary endpoint was the overall response rate. [J] . Yokoyama Akihiro, Kada Akiko, Saito Akiko M., Acta medica Okayama . 2019,第6期

机译：通常不适合移植的老年多发性骨髓瘤（MM）患者具有很高的死亡和中止治疗的风险，因此需要一种方案，该方案应采用能够平衡安全性，耐受性和疗效的新型药物。我们评估了在不适合移植的老年初诊MM患者中，硼替佐米-地塞米松和来那度胺-地塞米松在63天周期内的交替治疗。在第1、8、15和22天每周一次皮下注射硼替佐米1.3 mg / m2;在第36-56天每天口服来那度胺15 mg;在第1、8、15、22、36、43、50和57天，口服地塞米松20 mg，共6个周期。主要终点是总体缓解率。
4. Risk Management of Medical Devices Ensuring Safety and Efficacy through ISO 14971 [C] . Alfred M. Dolan ASQ's Annual Quality Congress . 2004

机译：通过ISO 14971确保安全性和疗效的风险管理
5. Medical Device Recalls: The Need for an Updated Protocol in the 510k Approval Process for Medical Device Safety and Efficacy [D] . Boles, Kelly D. 2020

机译：医疗设备召回：在510K批准过程中需要更新的协议，用于医疗器械安全性和疗效
6. Efficacy tolerability and safety of an innovative medical device for improving oral accessibility during oral examination in special-needs patients: A multicentric clinical trial [O] . Mathieu Mogenot, Laurence Hein-Halbgewachs, Christophe Goetz, 2020

机译：一种创新医疗装置的功效耐受性和安全性以改善口腔检测在特殊需求患者中的口腔诊断：多中心临床试验
7. Assessment Of Innovative Medical Devices: Proving The Benefit For The Patient – Best Practices From Germany And France [O] . M Plaud, MF Kuehl, T Ecker 2017

机译：评估创新的医疗器械：证明患者的福利 - 德国和法国的最佳实践
8. Medical Device Safety and Efficacy Testing for Cutaneous Oxygen Monitors and Digoxin Diagnostic Products [R] . Firth, L. M. , Couvillon, L. A. , Charest, M. , 1981

机译：皮肤氧监测仪和地高辛诊断产品的医疗器械安全性和有效性测试

Benefit Assessment of Medical Devices of High Risk Classes in Germany: Adaptive Approaches to Balance Early Access and Safety and Efficacy Required?

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