India and China offer attractive environments for clinical studies, with India emerging as a major market for clinical trials
and China not far behind. Both countries provide huge and accessible treatment-naïve patient populations and cost-effective
research opportunities with low procedure and professional fees. While these countries presently account for less than 1%
of the total FDA-regulated clinical research,1 forecasters estimate an expanding market for new clinical trials in both countries.
In this article, we describe why this rapidly developing market for clinical trials will create an industry wide challenge
for researchers who have less than a complete understanding and experience with cultural issues and nuances of clinical trials
in India and China. We focus on the key components of investigator grant budgeting and negotiating in these countries, detailing
how clinical investigators can maximize their resources and enhance their trials in these rapidly expanding economies.
Procedure and Professional Fees: India vs. the United States
|
To construct budgets that reflect market conditions in both India and China, the industry must have access to current actual
cost per visit and cost per patient numbers. These data ensure successful budget negotiation and create a positive relationship
between pharmaceutical companies and the clinical sites in these countries.
What companies say
Procedure and Professional Fees: China vs. the United States
|
We contacted more than 30 sponsor companies to determine if they anticipated new clinical trials in China or India in 2007.
The companies indicated that for 2007, nearly 4% of new clinical trial sites would be in India and 5% in China; by 2010, they
expect this number to jump to 10% of new sites in India, and another 10% in Asia, especially China. These forecasts match
A.T. Kearney's Overall Country Attractiveness Index,2 which ranks India and China as the most attractive countries for clinical research after the United States. This index was
constructed using five variables: Patient Pool, Cost Efficiency, Regulatory Conditions, Relevant Expertise, and Infrastructure
and Environment.
Clinical research in India
India provides an attractive setting for clinical research. Some of the benefits include:
- More than 500,000 English-speaking doctors, many trained in the United States or UK
- An enormous naïve patient population
- The highest number of FDA-approved laboratories outside of the United States.
The larger cities of Mumbai, New Delhi, and Chennai offer both large patient populations and better equipped research institutions,
which have the capability of handling greater patient populations as well as more complex trials. Some examples include the
Adyar Cancer Centre in Chennai and the Tata Memorial Hospital in Mumbai. The major ongoing clinical trials in India are for
cardiovascular diseases and diabetes.
In 2000, there were 60 unique 1572s filed; this number increased to 174 in 2004 (0.5% of the global 1572 filings). By 2010,
the clinical research market is expected to surpass $2 billion.3
Investigator grant budgeting
Of course, low cost budgeting for clinical trials and the potential for significant cost savings in India's emerging market
provide incentives for companies as they look for ways to contain expenses in the expanding clinical services industry.
