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世界の臨床試験:最新の動向と進化

Global Clinical Trials – Current Trends and Recent Advancement

 

出版社 出版年月電子版価格
CBR Pharma Insights
CBRファーマインサイツ
2019年1月US$2,995
シングルユーザライセンス(PDF)

サマリー

米国調査会社CBRファーマインサイツ(CBR Pharma Insights、GBIリサーチ社の傘下)の調査レポート「世界の臨床試験:最新の動向と進化」は、世界の多くの臨床試験の最新動向を評価し、トップ10の治療分野、地域の臨床試験、前年比のトップ10の治療分野の臨床試験などについて記載している。

Description


GBI Research’s latest report, Global Clinical Trials—Current Trends and Recent Advancement, provides an in-depth assessment of the current trends in the number of clinical trials globally, Top 10 therapy area, geography wise clinical trials, YOY clinical trials in top 10 therapy area.

Major sponsor are focusing on oncology as Cancer cases and related deaths continue to increase globally. While new cancer therapies are being identified offering new options for patients, many patients continue to live with cancer as a chronic disease. Nevertheless, many still succumb to their disease. As cancer is a huge and worldwide challenge, it is of little surprise that of all clinical trials registered for oncology is the greatest in number for any year during past decade.

This report provides GBI Research’s analysis on Number of clinical trials and Average recruitment size by Top 10 sponsor, Global – 2013-2018 (Q3)

An overview of clinical guidelines reforms has been provided to show how regulatory affect the clinical trials cost and duration. How innovative clinical trials has solved those problems. This report also provides key insights on how CRO companies and Technological advancement has helped the pharma companies in cost and time. Now clinical trials are conducted on global level and especially in those areas where cost of conducting clinical is less such as Pharma emerging markets.

An overview of technological advancement has also been provided with collaboration of pharmaceutical companies.

Scope

  • How many clinical trials being conducted worldwide?

  • Which are top therapy areas in terms of number of clinical trials?

  • Which type of sponsor vital in terms of conducting clinical trials in different therapeutic areas?

  • Year over year clinical trials in Top 10 therapy areas.

  • Which are the top 10 indication in top therapy areas?

  • Top 10 indications in overall therapy areas.

  • How many patients are being recruited in top 10 therapy areas?

  • Average duration of clinical trials in top 10 therapy area.

  • What is average recruitment size and clinical trials by Top 10 sponsor?

  • What are the total number of deals completed between institutions and industries?

  • How many clinical trials are ongoing in different geography areas?

  • What are the main reasons which caused termination and withdrawal of clinical trials?

Reasons To Buy

  • This report will allow you to:

  • Understand the clinical trials analysis YOY (2007-2018) in Phase 0, Phase I, Phase II, Phase III, and Phase IV.

  • Understand the analysis of top 10 therapy areas by number of clinical trials in 2007-2018 and in top therapy area top 10 indications.

  • Gain an understanding of the major sponsor and major area of research and development.

  • Understand the analysis of YOY FDA approval of precision medicine and primary end point analysis in oncology.

  • Understand the clinical reforms in different countries and benefits of those changes.

  • Understand the Novel approach of clinical trial design in oncology.

  • Understand the role of clinical supply chain management to conduct clean in effective manner.

  • Understand the role of technological advancement in clinical trials and importance of CRO for the same.



目次

Executive summary

Clinical trial analysis – overview

• Significant Increase in Clinical Investigations During Last Decade With Highest in Phase II

• Spotlight is on Oncology Due to Increase in Trial Accrual and Supportive Regulatory Policies

• Large Number of Clinical Trials From Institution Bring Innovation Into the Pipeline

• Top Therapy Areas to Maintain a Grip to Lead The Market

• Industry Sponsored Clinical Trial Trend, Oncology, Global – 2013-2018(Q3)

• Industry Sponsored Clinical Trial Trend, CNS, Global – 2013-2018(Q3)

• Industry Sponsored Clinical Trial Trend, Infectious Diseases, Global – 2013-2018(Q3)

• Industry Sponsored Clinical Trial Trend, Metabolic Disorder, Global – 2013-2018(Q3)

• Industry Sponsored Clinical Trial Trend, Cardiovascular Disorder, Global – 2013-2018(Q3)

• Industry Sponsored Clinical Trial Trend, Gastrointestinal Disorder, Global – 2013-2018(Q3)

• Industry Sponsored Clinical Trial Trend, Immunological Disease , Global – 2013-2018(Q3)

• Industry Sponsored Clinical Trial Trend, Respiratory Disorder , Global – 2013-2018(Q3)

• Industry Sponsored Clinical Trial Trend, Musculoskeletal Disorder , Global – 2013-2018(Q3)

• Industry Sponsored Clinical Trial Trend, Hematological Disorder, Global – 2013-2018(Q3)

• Diabetes Outnumbers Breast Cancer when Trials Are Analyzed by Indication

• Proper Trial Recruitment Offers a Clear Advantage Resulting in Cost and Time Savings

• Increase in Clinical Trial Duration Benefiting the Trial Design

• Increasing Focus on Precision Medicine Leading to Longer Trial Duration and Reduced Recruitment Size

• Diverse Therapeutic Expertise of Top 10 Global Pharmaceutical Companies

• Average Recruitment Size Varies Depending on focused Therapy Areas by top 10 Companies

• Big Pharma Is Attracted To Early-stage Deal With Institutions

• Global Migration Of Clinical Research with Increasing Focus on Asia-Pacific

• Withdrawal Whys And Wherefores In Clinical Trials By Major Therapy Area

• Learning Reasons From Termination Can be Efficient For Companies

 

Recent Changes in Clinical trial guidelines

 

• The US Toughens Rules for Clinical Transparency: Investigators are now required to Disclose Even Unsuccessful Trials

• Recent Changes in Clinical Trials Guidelines in Europe

• Japan’s New Clinical Research Act will Facilitate Implementation of Clinical Research by Obligating the Researchers

• Priority Review Has Fast-forwarded The Drug Approval Timelines in Australia

• Significant Regulatory Changes In China is likely to Accelerate rug Approval Timelines

• Shortening of IND & NDA Review Has Reduced The Approval Timelines in China

Clinical Trial registry

• Primary National Registries for Clinical Trials

Why Do Recruitment Efforts Fail to Enroll Enough Participants?

Other Challenges in Clinical Trials

Novel Approach For Clinical Trial Design Helps Translate Clinical Trial Evidence To Patient Care

Clinical Supply chain Management

• Meeting Clinical Trials Timelines is Important to Save on Cost

• Clinical Supply Chain Management (CSCM) Are Helping in Speed Up R&D

• Key Factors for Efficient Supply Chain Management in Clinical Trials

• Key Distribution Model in Clinical Supply Chain Management is Best Idea for Executing a Successful Clinical trial

• Outsourcing For Clinical Trials Resulted In Cost Reduction

• Clinical Supply Chain – Case Study

• Outsourcing—A Way towards Discovery And Development Of Drug

• CRO Activity in 2018 (Q3)

 

Technological Advancement in Clinical Trials

• Technological Advancement

 

Bibliography

 

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