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癌治療薬の開発戦略:大きな商業的可能性、しかし特定のニーズに対処する必要性

Oncology Development Strategies - Considerable Commercial Potential but Specific Needs Must Be Addressed

発行 CBR Pharma Insights 商品コード 274487
出版日 ページ情報 英文
納期: 即日から翌営業日
価格
本日の銀行送金レート: 1USD=114.77円で換算しております。

2016年12月31日まで 年末キャンペーン割引: CBR Pharma Insights社発行レポート
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癌治療薬の開発戦略:大きな商業的可能性、しかし特定のニーズに対処する必要性 Oncology Development Strategies - Considerable Commercial Potential but Specific Needs Must Be Addressed
出版日: 2013年01月01日 ページ情報: 英文
概要

癌治療はこの10年で大きな発展と進歩が見られた領域です。しかし、癌はすべての治療領域のなかで全体的な臨床的成功率が最も低い領域のひとつであり、承認へ向けたフェーズ?へ進むのは癌治療薬のわずか3分の1です。癌の臨床試験は、主に利用可能なエンドポイント数、適応可能な試験設計のニーズの高まり、および臨床研究にふさわしい患者のタイプによって、他の治療領域よりも複雑になる傾向があります。

当レポートでは、抗がん剤の開発動向について調査し、規制のメカニズム、癌の臨床試験設計の主要側面の分析、各エンドポイントのメリット、代用試験、癌の臨床試験・治療薬開発におけるバイオマーカーの重要性、および成功する抗がん剤発売を計画する際の重要な用件などを分析しており、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

調査手法

癌が異なる理由?

癌の臨床試験

  • エンドポイント
  • 試験設計
  • バイオマーカー
  • 患者へのアクセス
  • 地域別データの必要性

規制戦略

  • 癌治療の認可を促進する適切なメカニズム
  • 重要な成功因子

効果的な癌治療開始戦略

  • 開始の優先順位付け
  • 価格・医療費償還戦略
  • 通信プランニング
  • 不完全なデータによる開始

付録

目次
Product Code: CBRSV039

The oncology therapeutic area has seen significant development and advances over the last decade. However, oncology has one of the lowest overall clinical success rates of all therapy areas with only a third of oncology drugs that get to Phase III proceeding to approval. There are a number of factors that will affect the likelihood of success in oncology drug development and these must be taken into consideration when designing the clinical development plan. Oncology clinical trials tend to be more complex than those in other therapy areas, largely due to the number of endpoints that can be utilized, the growing need for adaptive trial design and the types of patients that are eligible for the clinical studies. While overall survival is the gold standard endpoint, achieving this is challenging for many oncology trials and other endpoints such as progression-free survival are frequently used as surrogates.

The approval of oncology drugs has been facilitated by regulatory mechanisms that have been put in place to expedite the process for drugs with small patient populations or that address areas of high unmet need. Programs to allow early access to developmental drugs are becoming the norm in oncology, largely driven by the high unmet need and serious nature of the disease, but also due to a desire to obtain real-life data.

The report, “Oncology Development Strategies - Considerable Commercial Potential but Specific Needs Must Be Addressed”, was written to provide support and guidance to companies who are both new entrants and long time players in the oncology space. CBR Pharma Insights provides in-depth analysis on the challenges that exist in developing new oncology products and launching them successfully into a challenging health care climate.

Key Reasons to Purchase

  • Provides insight into why the development of oncology drugs is different compared to other therapy areas and the implications for the overall process
  • Enables you to understand the regulatory mechanisms in place to expedite approval of new oncology drugs and how these should be incorporated into strategic launch planning
  • Provides in-depth analysis of key aspects of oncology clinical trial design, examining the merits of different endpoints, alternative trial designs and the importance of biomarkers in oncology clinical trials and drug development
  • Better understand the key critical requirements when planning for a successful oncology launch, including the impact of indication sequencing and how to address specific pricing and reimbursement needs
  • Gain clear and actionable recommendations on crucial factors to consider when progressing a new oncology drug through clinical testing, the regulatory process and launch

Table of Contents

  • Executive summary
  • Methodology
  • Why is oncology different?
  • Oncology clinical trials
    • Endpoints
    • Trial design
    • Biomarkers
    • Access to patients
    • Regional data needs
  • Regulatory strategies
    • Mechanisms in place that can facilitate oncology approvals
    • Critical success factors
  • Effective oncology launch strategies
    • Launch sequencing
    • Pricing and reimbursement considerations
    • Communication planning
    • Launching with immature data
  • Appendix
    • List of sources
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