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市場調查報告書
研究開發趨勢:心房纖維顫動患者預防中風用的抗凝血劑─即將上市的重量級新產品將留下永不消失的足跡
R&D Trends: Anticoagulants for stroke prevention in atrial fibrillation - Upcoming heavy hitters leave a permanent mark
| 出版商 |
Datamonitor |
| 出版日期 |
2011年11月 |
商品編碼 |
229456 |
| 內容資訊 |
英文 Pages: 38 |
| 價格 |
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研究開發趨勢:心房纖維顫動患者預防中風用的抗凝血劑─即將上市的重量級新產品將留下永不消失的足跡 是由出版商Datamonitor在2011年11月所出版的。
這份英文市場調查報告書包含Pages: 38 價格從美金3800起跳。
本報告提供在新藥的相繼上市下，面臨新藥開發策略根本性變化的心房纖維顫動患者預防中風用的治療藥相關調查分析，彙整臨床實驗設計相關的重要事項及最近臨床實驗的概況等資料，概述為以下內容。
目錄
第1章 摘要整理
第2章 概況
第3章 臨床實驗的設計
- 臨床實驗相關策略
- 臨床實驗設計的中心
- 臨床實驗的設計的未來發展
第4章 臨床實驗平台的概況
第5章 比較療法與其對象產品概要
第6章 開發初期階段的方法
第7章 心房纖維顫動患者預防中風的未來
第8章 參考文獻
第9章 附錄
Description
Introduction
With Pradaxa (dabigatran) and Xarelto (rivaroxaban) approved for stroke prevention in atrial fibrillation and two other candidates well on their way towards the market, development activity in this arena is at a cross-roads. Such is the likely transformation in care represented by these four products that development strategies are already fundamentally changing.
Features and benefits
- Key elements of clinical trial strategy and design for anticoagulant products targeting stroke prevention in atrial fibrillation
- Overview of late stage clinical pipeline, recent discontinuations and the nature of future candidates
- Analysis of target and minimum acceptable product profiles as compared to current standards of care
Highlights
- Anticoagulant pipeline casualties have historically been clinically driven, however, there is evidence that pipeline discontinuations are increasingly being driven by commercial decision making. Developers now face a decision between pursuing costly mega-trial strategies and high risk niche strategies offering few guaranteed returns.
- Very few companies have the resources to fund increasingly complex, expansive trials. Fewer will be inclined to perform these trials as four breakthrough products vie for share. Niche sub-sectors may offer alternative opportunities but may still require assessment against new products for which clear roles are far from established or accepted.
- Datamonitor predicts a hiatus in the aggressive hunt for warfarin alternatives until the current crop are better integrated into clinical practice. This could take years, and is likely to be followed by a wave of me-too products and the systematic fragmentation of the market by competitors seeking to isolate high value patient subgroups.
Your key questions answered
- Understand the factors driving the shape of clinical trial strategies for the current crop of new market entrants
- Predict the likely impact of four breakthrough products on trial strategy and design in stroke prevention
- Identify the prerequisites for the would-be new market entrants of the future
TOC
Executive Summary
- Strategic scoping and focus
- Datamonitor key findings
OVERVIEW
CLINICAL TRIAL DESIGN
- Trial strategy
- Launch order and risk mitigation
- Atrial fibrillation as a showcase indication
- One trial or two?
- Pivotal trial design
- Comparators
- Endpoints
- Superiority versus non-inferiority
- Trial size and duration
- Allocation and blinding
- Inclusion criteria
- Exclusion criteria
- Future developments in clinical trial design
CLINICAL PIPELINE OVERVIEW
- Recent late-stage discontinuations
COMPARATOR THERAPIES AND TARGET PRODUCT PROFILES
- Comparator 1: warfarin
- Comparator 2: aspirin
- Target product profile versus current level of attainment
INNOVATIVE EARLY-STAGE APPROACHES
- TB-402: ThromboGenics and BioInvent International
- Infestin-4: CSL
THE FUTURE OF STROKE PREVENTION IN ATRIAL FIBRILLATION
- Cost effectiveness put under the microscope
- Patient and product selection enters new realms of complexity
- Trading convenience for contact while still mitigating risk
- Keeping abreast of broader changes in atrial fibrillation management
- Integrating new approaches into clinical trial design
BIBLIOGRAPHY
APPENDIX
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