The use of emerging markets to conduct clinical trials is a growing trend due to faster patient enrollment and lower costs. One emerging market that has attracted significant interest is China. With a population of 1.33 billion, the country has an open market for clinical trials on populations that have diseases of both the developed and developing world. Some of the most compelling reasons for conducting clinical trials in China include:
* Size - Large treatment-naive patient pool with motivated uninsured patients.
This provides significant value for late stage clinical trials with difficult -to
-enroll indications or lang enrollment periods.
* Speed - High patient enrollment rate per site, an advantage of a centralized
healthcare system in metropolitan areas with 1,500 to 3,000 beds per
hospital
* Business Climate - A more sponsor-friendly regulatory climate with emphasis on improving trial quality and ensuring
patient safety and rights. China's SFDA is working closely with global industry leaders and regulatory bodies to
harmonize and streamline its regulatory processes.
* Global Acceptance - Chinese clinical study data has been accepted by the Food and Drug Administration (FDA), the
European Medicines Agency (EMEA) and Japanese regulatory agencies. Label changes were approved by the FDA based
on large outcome trials conducted in China. The EMEA has also accepted late phase studies performed in China.
* Trained Workforce - Motivated GCP-trained investigators and workforce: A growing population of US and EU trained
medical and scientific professionals supporting high quality global clinical trials.
* Value - Lower operating costs due to lower costs of labor and overhead and significantly faster patient enrollment.
* Rapid Growth - China's pharmaceutical market is the fastest growing in the world. It is currently ranked fifth and is
projected to be second by 2020. Chinese clinical trial data is advantageous for sponsors seeking product approval
for access to its market.
Faster Development
Through Emerging Markets
Copyright 2012 Truevic