Platform Trial Designs in Drug Development: Umbrella Trials and Basket Trials
暫譯: 藥物開發中的平台試驗設計：傘型試驗與籃型試驗
Antonijevic, Zoran, Beckman, Robert A.
- 出版商: CRC
- 出版日期: 2020-12-18
- 售價: $2,420
- 貴賓價: 9.5 折 $2,299
- 語言: 英文
- 頁數: 322
- 裝訂: Quality Paper - also called trade paper
- ISBN: 0367732637
- ISBN-13: 9780367732639
海外代購書籍(需單獨結帳)
相關主題
商品描述
Platform trials test multiple therapies in one indication, one therapy for multiple indications, or both. These novel clinical trial designs can dramatically increase the cost-effectiveness of drug development, leading to life-altering medicines for people suffering from serious illnesses, possibly at lower cost. Currently, the cost of drug development is unsustainable. Furthermore, there are particular problems in rare diseases and small biomarker defined subsets in oncology, where the required sample sizes for traditional clinical trial designs may not be feasible.
The editors recruited the key innovators in this domain. The 20 articles discuss trial designs from perspectives as diverse as quantum computing, patient's rights to information, and international health.
The book begins with an overview of platform trials from multiple perspectives. It then describes impacts of platform trials on the pharmaceutical industry's key stakeholders: patients, regulators, and payers. Next it provides advanced statistical methods that address multiple aspects of platform trials, before concluding with a pharmaceutical executive's perspective on platform trials. Except for the statistical methods section, only a basic qualitative knowledge of clinical trials is needed to appreciate the important concepts and novel ideas presented.
商品描述(中文翻譯)
平台試驗在一個適應症中測試多種療法，或在多個適應症中測試一種療法，或兩者皆是。這些新穎的臨床試驗設計可以顯著提高藥物開發的成本效益，為遭受嚴重疾病的人們帶來改變生命的藥物，並可能以較低的成本實現。目前，藥物開發的成本是不可持續的。此外，在罕見疾病和小型生物標記定義的腫瘤學子集方面存在特定問題，傳統臨床試驗設計所需的樣本量可能無法實現。
編輯們招募了該領域的關鍵創新者。這20篇文章從量子計算、患者的資訊權利和國際健康等多元視角討論試驗設計。
本書首先從多個角度概述平台試驗。接著描述平台試驗對製藥行業主要利益相關者的影響：患者、監管機構和支付者。然後提供解決平台試驗多個方面的先進統計方法，最後以製藥高管對平台試驗的看法作結。除了統計方法部分，僅需對臨床試驗有基本的定性知識，即可理解所呈現的重要概念和新穎想法。
作者簡介
Robert Beckman is Professor of Oncology and of Biostatistics, Bioinformatics, and Biomathematics at the Lombardi Comprehensive Cancer Center and the Innovation Center of Biomedical Informatics, Georgetown University Medical Center. He has played significant leadership roles in developing new oncology clinical research groups at four pharmaceutical companies, while co-inventing several novel clinical and statistical development strategies. His versatile publication record comprises more than 250 contributions ranging from computational chemistry to clinical oncology.
The editors are past and current chairs of the Drug Information Association Adaptive Design Scientific Working Group, an international group of over 200 statisticians focused on novel clinical study designs and their role in bringing new medicines to patients.
作者簡介(中文翻譯)
Zoran Antonijevic 是 Z-Adaptive Design 的擁有者和顧問。他曾在製藥公司和合同研究機構（CRO）擔任高級職位，並設計了超過 100 個臨床試驗，涵蓋多個治療領域，其中許多包含適應性設計。他撰寫了多篇論文和科學報告，並編輯了 Optimization of Pharmaceutical R&D Programs and Portfolios.
Robert Beckman 是喬治城大學醫學中心 Lombardi 綜合癌症中心的腫瘤學教授，以及生物統計學、生物資訊學和生物數學的教授。他在四家製藥公司中發揮了重要的領導角色，負責開發新的腫瘤學臨床研究小組，同時共同發明了幾種新穎的臨床和統計開發策略。他的多元出版紀錄包括超過 250 篇貢獻，涵蓋從計算化學到臨床腫瘤學的各個領域。
編輯們是藥物資訊協會（Drug Information Association）適應性設計科學工作組的前任和現任主席，這是一個由超過 200 名統計學家組成的國際團體，專注於新型臨床研究設計及其在將新藥帶給患者中的角色。
