薬剤安全性に対する問題対応

Abstract

Overview

Introduction

High profile drug withdrawals and negative public attention has placed drug safety at the top of the pharmaceutical industry' s agenda. This report will examine pharmacovigilance technology solutions designed to alleviate the challenges in drug safety management faced by the pharmaceutical industry and the regulatory agencies.

Scope

• Identifies the key forces driving the adoption of pharmacovigilance technology solutions
• Analyzes the crucial issues that will impede the uptake of drug safety monitoring tools
• Discusses the key functionalities needed for a complete pharmacovigilance solution
• Offers insight into how IT vendors can improve their products

Report Highlights

Pharma companies must adapt to constantly changing government regulations to ensure compliance and eventual approval of their drug products, and response to these new rules is driving the adoption of pharmacovigilance solutions.

It is essential for pharma companies to implement proactive pharmacovigilance strategies which encompass strong data management systems, signal detection technologies, and adverse event reporting systems to ensure production of a safe and effective drug that will be approved and will maintain a favorable risk-benefit ratio post-approval.

The industry is still skeptical of the benefits provided by signal detection technologies. IT vendors must take an active role in educating companies about these technologies, and position signal detection as an essential tool for developing comprehensive risk management strategies which will not only benefit the company, but ultimately the public.

Reasons to Purchase

• Validate your market messaging and positioning in the pharmaceutical industry
• Identify strategies that will increase adoption of pharmacovigilance technologies
• Understand the technology trends that are shaping the future of drug safety

Table of Contents

• Overview
  • Catalyst
  • Summary
• Key Messages
  • Pressures to adhere to government regulations are driving the adoption of PV solutions
  • The pharma industry turns to drug safety solutions to ease financial woes
  • Signal detection in clinical research is a necessity to increase efficiency and reduce costs
  • In its nascent stages, companies have been reluctant to adopt PV technologies
  • There are no leading providers of PV solutions, and partnerships are essential
• Table of Contents
• Table of figures
• Market Opportunity
  • Growing drug safety issues are leading to enhanced pharmacovigilance activities
    • Technology is crucial in developing a comprehensive pharmacovigilance strategy
      • Post-market surveillance capabilities is essential for a robust PV system
  • Government regulations are driving the adoption of PV solutions
    • The FDA has a long standing history of drug safety regulations...and shortage of funds
      • The FDA becomes more proactive and enhances drug safety and its IT systems with PDUFA IV
      • FDA will demand more safety data and proactive pharmacovigilance from the industry
    • New reforms standardize the European PV system
      • The EMEA pharmacovigilance system is still developing
  • The pharma industry turns to drug safety solutions to ease financial woes
    • Safety warnings and drug withdrawals hurt companies' business portfolios
      • Unexpected litigation costs lower the overall bottom line of a company
    • Pharma companies will save millions of dollars with early detection of an unsafe drug
  • In its nascent stages, companies have been reluctant to adopt PV technologies
    • The pharma industry' s conservative nature impedes the adoption of PV systems
    • Companies relate new PV technologies with older, more cumbersome statistical tools
    • Implementation of PV solutions requires an overhaul of existing IT systems
• Customer Impact: Using PV Technologies to promote public health
  • Signal detection in clinical research is a necessity to increase efficiency and reduce costs
    • Clinical trials signal detection must provide an intuitive interface
      • A simple example of how clinical trials signal detection is used for proactive pharmacovigilance
    • Detection of safety signals during clinical trials can save pharma companies millions of dollars
  • Consumer knowledge and participation significantly affect pharmacovigilance activities
    • Consumers require more transparency into the pharmacovigilance process
  • Pressures to adhere to global regulations increases the uptake of PV solutions
    • More data and advanced IT tools mean better safety monitoring and reporting
      • PV technologies to support post-market surveillance are more important now then ever before
      • Signal detection is becoming increasingly important during clinical trials
• Technology evolution
  • Signal detection and management solutions are essential for proactive pharmacovigilance
    • Signal detection technologies must be user-friendly and accessible from global sites
  • Adverse event reporting systems are becoming increasingly important
  • In this nascent market, there are no clear leaders for PV solutions
    • Examples of vendors providing total PV solutions
      • Aris Global develops a data mining and signal detection application to add to its PV suite
      • Phase Forward acquires Lincoln Technologies to provide a powerful set of drug safety solutions
      • TCS, Oracle, and DrugLogic collaborate to deliver a comprehensive and integrated PV solution
• Go to market
  • PV technologies must streamline the pharmacovigilance workflow
  • IT vendors must educate the industry on the usefulness of signal detection technologies
  • In a highly fragmented market, partnerships are essential
    • Vendors that openly communicate with their clients and put their needs first will prosper
  • Changing regulations will require vendors to continuously update their solutions
    • Ensure that IT solutions meet government standards for electronic records
  • A close eye should be kept on emerging markets
• APPENDIX
  • Definitions and Abbreviations
  • Methodology
  • Further reading
  • Ask the analyst
  • Datamonitor consulting
  • Disclaimer
  • List of Figures
    • Figure 1: Balance between risks and benefits for drugs to be approved
    • Figure 2: A typical pharmacovigilance system utilizing technology and strategy
    • Figure 3: Sources of risk from a drug, leading to an adverse drug reaction
    • Figure 4: Key drug safety-related events in FDA history
    • Figure 5: Stock price for Merck on NYSE for 2004, US$
    • Figure 6: Stock price for GlaxoSmithKline on NYSE for 2007, US$
    • Figure 7: Drug discovery and development process
    • Figure 8: Challenges facing the pharmaceutical industry
    • Figure 9: Adverse event reporting systems in North America and Europe
    • Figure 10: An example of a complete PV system