Emerging Markets Clinical Trials: Asia (PH144)

China, India and Other Emerging Asian Countries

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Published 2010
193 Pages
400+ Metrics
120+ Charts and Diagrams

Overview Metrics Excerpts

Harness the best of East and West to advance clinical development
Among the globe's emerging
clinical research 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 clinical 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 Asian clinical trials strategy:
Address Intellectual Property Concerns in Emerging Clinical Research Markets
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.
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Clinical Research in Asia 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:
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.
Asian Clinical Trials 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.
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Clinical Research in Asia Report Sample
The following excerpt is taken from Chapter 1, 'China.' The first half of the chapter explores in-depth China's clinical development environment, including demographics, economics, politics and healthcare system.
Economics
Healthcare has been increasing in importance to the Chinese government for decades. As the economy grows, so too has the need for medical care in outlying rural areas. According to IMS Health, between 2011 and 2013, China will see a growth spurt in the pharmaceuticals market large enough to make it the world's third-largest market for prescription medication.
The impact of China's economic reforms and rapid growth has affected its healthcare system. While the country's prosperity has improved medical treatment for millions of citizens, some poorer communities are struggling to receive proper healthcare as the country transitions from the Cooperative Medical System (CMS) to a privatized, fee-for-service system.
Private medical practice had been banned during the Cultural Revolution. But following that period and throughout the 1980s, China's Ministry of Health and its State Council encouraged privatization. Yet it spread gradually throughout the country's provinces. At first, Chinese physicians began part-time private practices at public health facilities. It wasn't until the late 1990s or early 2000s that China began registering and licensing private medical practitioners. When the government began to dismantle the initial state-owned enterprises and rural healthcare programs, such as "barefoot doctors" - farmers who received basic medical training - there were little to no alternatives in place to handle the medical need.
The transition to privatization has led to confusion and challenges for finding medical treatment in poor communities. Many public health facilities that used to provide medical care to poor populations have transitioned to fee-for-service institutions; in some cases, the transition has occurred overnight, leaving whole populations unable to afford the same level of medical care.

The following is an excerpt from Chapter 1, section 2, "Clinical Development Strategy." The section includes executives' best practices based on their experiences in conducting trials in China.
Working with CROs
In China, the prevalence of CROs is expanding; however, study respondents did not use CROs at the same rate as in other countries. Analysts at Goldman Sachs note that the CRO market has grown substantially in the last few years and should continue growing as China solidifies its intellectual property position. Regardless of this growth, multiple study respondents stress the difficulty of establishing FDA-level oversight when using vendors in the country.
Multinational CROs played a role in six clinical trial activities for about one-third of respondents, while local vendors were used only to manage investigators for a few respondents' trials. Currently, study respondents leverage CROs' expertise in China to further their growth in the market. But clinical trial sponsors continue to have concerns. One interviewed executive said, "We work with CROs in China because they provide opportunities to expand in China when and where our company cannot expend internal resources. However, the oversight on activities at CROs in terms of compliance and quality is challenging."
Foreign multinationals coexist with hybrid foreign-local firms and more than 100 local CROs. Major CROs operating in China include Quintiles (which led the way into the market, opening its local offices in 1997), Covance, PPD's Excel PharmaStudies, CRL, PAREXEL, MDS, ICON, PharmaNet, Kendle, Omnicare, Tigermed, Aperio, George Clinical and Medidata. Logistics firms such as Marken, Phase Forward, Promasys, Transperfect and Zuellig Pharma also operate in China. Support for asian clinical trials comes from organizations such as ChinaBio Accelerator, Shanghai Clinical Research Center (SCRC), the Sino-American Pharmaceutical Professionals Association and the US Chinese Anti-Cancer Association.
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