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臨床開発と治験の設計:全段階に渡る首尾一貫したアプローチの開発

Clinical Development and Trial Design - Developing a Coherent Approach From Beginning to End

発行 CBR Pharma Insights 商品コード 290383
出版日 ページ情報 英文 48 Pages
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臨床開発と治験の設計:全段階に渡る首尾一貫したアプローチの開発 Clinical Development and Trial Design - Developing a Coherent Approach From Beginning to End
出版日: 2012年06月15日 ページ情報: 英文 48 Pages
概要

コスト抑制傾向の強い現在の環境下で、臨床開発計画は治験のプロセスを見直し、コスト・時間効率性を促し、スムーズな治験進行を実現させます。また、臨床開発の全ての局面を取りまとめて、臨床面・商業面での合理性にかなった一体的なアプローチを実現化します。一方、臨床開発計画の着実な進展には、様々なアプローチを採用する必要があります。

当レポートでは、今後の医療産業における臨床開発のあり方について分析し、その進行段階の概要、各段階での考慮すべき事項、代表的事例などについて調査・考察して、その結果を概略以下の構成でお届けします。

エグゼクティブ・サマリー

分析手法

臨床開発の計画

臨床開発計画に当たっての主な考慮事項

  • クリニカルコミュニケーション
  • 組織内部/外部からの人材採用
  • 規制の関連性
  • 科学面・商業面での事業協力
  • 医療面での経済性

治験(臨床試験)の設計

  • 治験のプロトコル
  • 治験の目的
  • 優先順位の設定
  • 患者の選定
  • 治験のエンドポイント
  • 調整可能な治験の設定
  • ロジスティクス上の課題
  • 場所の選定
  • コミュニケーション

治験・認証過程における新たな動向

  • LPAD(Limited Population Antibacterial Drug)の経路
  • 腫瘍に関する認証傾向

付録

目次
Product Code: CBRSV034

A good clinical development plan will ensure success throughout the product lifecycle.

In today's cost constrained environment, the clinical development plan can help refine the trial process, encouraging cost and time efficiencies and ensuring a streamlined process throughout.

The clinical development plan ties together all aspects of product development, enabling an incorporated approach to the clinical and commercial rationale of product development.

A variety of approaches should be adopted to ensure a robust clinical development plan is developed. Early initiation of the clinical development plan is critical for the execution of a successful product development process.

A proactive approach to the processes and objectives encompassed in the clinical development plan must be adopted..

The report, "Clinical Development and Trial Design - Developing a Coherent Approach From Beginning to End", was written to provide insights & analysis to teams and companies to support getting a product to market quickly and successfully. This report will help ensure development teams are on top of all necessary components of product development while providing suggestions which enable them speed the process to a successful launch.

Scope

  • Devising a clinical development plan - key considerations
  • Review of clinical trial design stages - protocol, objectives, patient population selection, endpoints, site selection and issues
  • Recent developments

Key Reasons to Purchase

  • Understand what a clinical development plan consists of and how creating one at an early stage of new pharmaceutical product development will contribute to the overall success of the trial program and eventual commercial launch
  • Provides an overview of the recommended approaches to the range of activities that should be undertaken to ensure all aspects of clinical development are addressed
  • Enables you to understand the interaction between the commercial and scientific members of the clinical development team and how to ensure clear communication and ongoing cooperation throughout the clinical trial process
  • The report provides in-depth analysis of key aspects of clinical trial design, examining how the right endpoints, objectives and design are critical to guarantee eventual regulatory and reimbursement approvals
  • Benefit from up-to-date case studies and analysis examining changes in clinical studies, in particular in the fast-moving oncology therapy area, and how new initiatives are breathing life into the stagnant antibacterials market

Table of Contents

  • Executive summary
  • Methodology
  • Clinical development plans
  • Key considerations for a clinical development plan
    • clinical communications
    • internal versus external resourcing
    • regulatory relationships
    • scientific and commercial cooperation
    • health economics
  • Clinical trial design
    • the clinical trial protocol
    • the trial objective
    • superiority designs
    • patient population selection
    • trial endpoints
    • adaptive trial design
    • logistical issues
    • site selection
    • communication
  • Recent developments in clinical studies and approval processes
    • the LPAD pathway
    • approval trends in oncology
  • Appendix
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