Current Statistical Requirements for Pharmaceutical Clinical Trials in China
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Feng Chen
321
Current Statistical Requirements for Pharmaceutical Clinical Trials in China
Nanjing Medical University School of Public Health. Nanjing. China
Qiguang (ken South-East University, Nanjing. China Jie Chen Merck Research Laboratory. North Wales. Pennsylvania
Jason Hsu Department of Statistics. The Ohio State University, Columbus, Ohio
During the past several years, China has issued a number of drug regulations and guidelines. Based primarily on international guidance such as ICH guidance and FDA regulations, these draft and final guidelines greatly improve the approval process of pharmaceutical products in China. Understanding theseguidelinesis useful to international companies interested in conducting clinical trials
Key Words China: ICH; FDA: Drug approval: New drug application; Clinical trial; Statistical principles
DRUG APPROVAL AND CLINICAL TRIALS I N CHINA
Correspondence Address lason Hsu, Department of Statistics. The Ohio State University, Columbus, OH (email: [email protected]).
conducted in China (1-4). According to Barnes (4), the number of clinical trials in China increased 25% between 2002 and 2004. Of the more than 250 trials conducted in China in 2004, all were part of multicenter international trials sponsored by multinational companies. The main reasons for such an increase are as follows:
A growing number of clinical trials are being
1. Improving infrastructure, including better educated staff, and increasing availability of clinical research organizations (CROs) 2. Increasing compliance with international standards such as Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) 3. Large patient population (eg. resulting in easier recruitment of patients for some orphan diseases) 4. Lower patient recruitment cost as well as staff and hospital compensation 5. Potential entry to the Chinese market
Regarding the Chinese pharmaceutical market, between 1998 and 2006, total pharmaceutical sales in China grew at an annual rate of more than 18%, reaching US$12 billion by 2006. The market share of import drugs is one fifth of the total market in 2006. With an aging population and anticipated expansion of government health care coverage, the predicted growth rate of pharmaceutical sales in China is 20% to 25% per an-
in China and entering the Chinese pharmaceutical market. The purpose of this article is to descn'be the development and contents of the Chinese version of Guidelines on Statistical Principles (GSP) for Clinical Trials, issued in March 2005. We discuss some successes as well as challenges in implementing the Chinese GSE and what can be anticipated for future clinical tials in China.
num from 2007 to 2012 (5). Indeed, with impressive economic growth, entrance into the World Trade Organization, greater transparency of regulatory activities, and more compliance with international standards, China has attracted much attention from the international pharmaceutical community (1-11). To enter such a lucrative drug market, the first obstacle faced by international ph
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