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Emerging Markets Clinical Development Series: Asia
Product ID : VSE-430-16440
Published Date : Nov 2010
Pages : 193

 

Overview:

Harness the best of East and West to advance clinical development

Among the globe's emerging markets, Asian countries tend to offer the highest number of available patients for trial participation. The region also hosts a thriving pharmaceutical and biotechnology industry, and medical education among investigators has come in-line with Western expectations for Good Clinical Practice. As more companies move clinical trials into this region, they will benefit for years to come from its inherent expertise.

Answer your burning questions about Asian trials with this report, which provides detailed data on China and India as well as information on trials in Malaysia, Hong Kong, Taiwan, Thailand, Singapore, South Korea and the Philippines. Learn the advantages and challenges that each of these countries presents, and use the benchmarks, metrics and best practices to avoid common pitfalls and solidify your clinical strategy:

Address Intellectual Property Concerns


Asia has a reputation for poor intellectual property protections, and this report uncovers the progress made in China, India and other Asian nations around IP protection. The report will also help you navigate regulations, healthcare infrastructure, costs and patient access.

Benefit from Strong Physician-Patient Relationships


Learn about the strong physician-patient relationships created in different Asian countries. Tap into these bonds to boost enrollment and retention for your clinical studies.

Explore Individual Country Benefits

Too often, companies approach specific emerging markets with regional strategies. This report illustrates the benefits that each individual country provides so that you can develop detailed plans for running trials in each market. Tap into the best ratios of cost, quality and timelines while using local partners to navigate culture, communication and regulations.


Table Of Contents :

Asia Emerging Markets Metrics

Executive Summary

    * Average percentage of budget saved by running a site in Asia
    * Average percentage of time saved by running a site in Asia
    * Population comparisons between Asian nations, the United States and Europe
    * Number of registered studies across profiled Asian countries
    * Rankings from surveyed companies of benefits and challenges:
          o Patient access
          o Patient retention
          o Regulatory environment
          o Intellectual property laws/practices
          o Cultural concerns
          o Communication and language
          o Clinical trial technology infrastructure
          o Supply chain management
          o Investigators' available knowledge base
          o Data standards
          o Investigator standards
          o Site management standards
          o Anticipated cost

The three chapters in Emerging Markets Clinical Development Series: Asia use primary and secondary information to provide comprehensive overviews of the clinical development environment in Asia:

Section 1: Clinical Development Overview

    * Key demographics (population/ethnic breakdowns, life expectancy statistics)
    * Key economic figures (GDP, labor force, distribution of family income)
    * Disease prevalence
    * Politics
    * Healthcare system
    * Pharmaceutical market (overall picture of market, leading local companies)

Section 2: Clinical Development Environment

    * Percentage of budget saved by running a trial in this location
    * Percentage of time saved by running a trial in this location
    * Assigning clinical development responsibilities

Clinical Trial Environment Scores and Trial Operations Scores:
Environment

    * Available knowledge base
    * Regulatory environment
    * Intellectual property laws and practices
    * Communication/language
    * Culture
    * Anticipated cost

Operations

    * Access to patients
    * Patient retention rates
    * Investigator standards
    * Data standards
    * Site management standards
    * Trial technology infrastructure
    * Supply chain management

Section 3: Individual Company Profiles

This report contains a total of 20 company profiles that contain the following components:
Company Background

    * Company mindset and key clinical feasibility factors
    * Factors that impact clinical environment

Clinical Environment Assessment:

    * Regulatory environment
    * Available knowledge base
    * Intellectual property laws/practice
    * Communication/language
    * Cultural concerns
    * Anticipated cost

Trial Operations Assessment:

    * Access to patients
    * Patient retention rate
    * Investigator standards
    * Site management standards
    * Data standards
    * Trial technology infrastructure
    * Supply chain management

Experience in Region

Activity in Region: Maps the geographic scope of the company's clinical operations within the region.

Experience Specific to Country: Provides information on the company's operations within the country, including year of entry, method of entry and current level of presence within the country.
Clinical Strategy in Country

Responsibility breakdown shows each company's clinical operations assignments among four groups - corporate team outside country, corporate team inside country, multinational CRO, and local CRO/vendor. The data detail 12 clinical responsibilities:

    * Protocol development
    * Site selection
    * Investigator training
    * Patient recruitment
    * Site monitoring
    * Investigator management
    * Data collection
    * Data management
    * Data cleaning/analysis
    * Medical writing
    * Regulatory agency communication
    * Health economics consideration

Clinical Environment and Trial Operations Scores

Shows a company's score for each of the clinical environment and trial operations factors listed above.


Publisher : Cutting Edge Information