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Chinese clinical trials industry ready

Data show that, at present, global annual cost of clinical studies for drugs is increasing, has reached the size of about 80 billion U.S. dollars. According to market research firm CMR's statistics, from 2000 to 2006, from a global contribution to the extent that the patient in the world to carry out clinical trials of drugs, the United States accounted for 41%, Germany 7%, France 4%, the United Kingdom, 4 %, less than 1% share of China and India and less than 0.5%. Thus, in recent years, although the pharmaceutical industry, clinical trials, has shown the European and American developed countries to developing countries in Asia, the shift, but in fact the latter's share is also very small, a huge space for development.

Rapid growth

Wyeth Clinical Research and Development Asia-Pacific vice president, Su Ling that as a chain of drug development in a part of clinical trials of drugs increasingly shows its importance. Because, as soon as possible in clinical trials to prove a drug is safe, effective or more effective than existing drugs, the pharmaceutical company's decision whether to continue the development of new drugs go on the key.
As a result, into the group of patients and test the speed of the availability of various pharmaceutical companies have become key to competition. In this context, a large population like China, while clinical trials based organizations and researchers a better country, naturally the favorite.
Beijing Novartis Pharmaceutical Co., Ltd. served as Medical Director of Novartis (China) Bio-Medical Research Ltd., Zhao Jian, director of External Affairs, it is stressed that China-based research team of experienced staff, global clinical research center of gravity to the order China as the representative of the emerging market shift is the inevitable trend of development of the industry.
Guangzhou Bo Ji Clinical Drug Research Center, Dr. Wang Tingchun told reporters that in recent years, China's done every year the number of clinical trials of drugs to an alarming 40% rate. In China's international multi-center clinical trials, the number from 2004 to less than 50 developed in 2007 to nearly 250.
At the same time, venture capital for the CRO's attention is also fully demonstrated that China's considerable potential for development of clinical trials industry. Risk investment like a wind vane, to attract their attention, it must be great room for development of those industries. At present, the industry's most CRO's boss, and venture capital firms have had contact with experience. However, a company boss revealed that, although the venture capital is very concerned about the CRO, but the industry really gets venture CRO companies have not much reason is that although the Chinese CRO market potential for clinical trials, but the field has not yet been fully development, the size of existing companies is still relatively small, while the national clinical trials for the drug if full liberalization of the market is not very clear manner. For venture capital firms, once they decided to launch an industry, it will not only invest in one or two companies, but many companies put into the scale, and quickly packed listing of these companies. If the clinical trials in China CRO market in the next five years to maintain an average annual growth rate of 40%, and in 2010 to 2011 was developed into a market the size of hundreds of millions of U.S. dollars, then, when the venture capital firm will be fully attack.
Good faith medical information consulting company Taihe Hai-Bo Wu, general manager of analysis, four main reasons why the clinical trials industry, to promote China's rapid development. First, the rapid growth of China's pharmaceutical market. In general, a drug research and development process of a country case if you have information, then it will be listed in the country more smoothly. Emerging as the fastest growing drug market, China has attracted more and more attention of transnational corporations. In order to rapidly occupy the drug market in China to conduct clinical trials for the future lay a good foundation to market. Second, in order to enhance competitiveness, improve the availability of group of patients to speed up test speed, cost savings, cross-border pharmaceutical companies in China have set up a fully functional global R & D center, which is driving China's clinical trials industry. Third, with the relevant departments of the Chinese medical market order rectification, the traditional generic drugs by local pharmaceutical companies to survive in the balance between generic drugs and innovative drug profits drop, it begins to attach importance to pharmaceutical innovation, an increase of innovative research inputs. 4 Drug Administration departments, with the increasingly stringent regulation of clinical trials, more clinical trials in China is widely recognized by the international pharmaceutical industry.


In fact, in clinical trials, while the rapid development of industry experts to carry out new drugs for clinical trials in China, the pros and cons of the controversy continues.
Su Ling believes that clinical trials of new drugs in China more good than harm. The so-called "profit" includes: Chinese subjects of early entry into the international multi-center trials can speed up the pace of new drug development; test results prove that drugs, if effective, the future market in China as soon as possible, so that benefit from Chinese patients; right researchers who , you can get the first new drug information, to enhance their R & D capability and accumulated experience; if the global drug R & D funding each year for a relatively large proportion invested in the Chinese market, then the local clinical research organization, whether in hardware or software can be obtained greatly improved.
By contrast, the "bads" is mainly a risk for the development of new drugs, may in some circumstances subjects "exposure" in a certain degree of risk where. This is a lot of those who hold opposing views will be emphasized in Chinese patients as a "mouse" point of view. For this problem, Wyeth China and Hong Kong Wu Xiaobin, president and managing director of the view that conducting human trials before the drug has been completed animal studies, the drug's safety is basically guaranteed. Moreover, these clinical trials is an international multi-center study of content. In other words, these tests carried out not only in Chinese patients, patients in the United States, Europe, patients also carried out, so this "harm" is not unique to China. Moreover, from a historical perspective, we are using chemicals, most of them developed by multinationals, while the clinical trials of these drugs are basically done in a foreign crowd.
Let Wu Xiaobin worry is that in the clinical trials industry, the process of transferring to developing countries, China is facing India, South Korea and other countries a strong challenge. Now, Thailand, India, South Korea and is actively preparing for the transfer of pharmaceutical clinical trials industry. In India, for example, in order to adapt to the new situation, the country has amended laws and regulations. As long as Europe and the United States approved clinical trials, India has basically approved a month can be carried out, but our country now needs almost nine months to a year to approve. Thus, while China's participation in clinical trials of new drugs more than five years ago, but compared with the surrounding emerging markets, relatively slow growth rate.

Start Wealth

So, China's drug clinical trials are difficult to open the door to it? A senior industry analysis for journalists secondary reason.
First, the relevant laws and regulations are far from perfect. For clinical trials that may arise complex irregularities, the existing law has not been fully involved. For example, pharmaceutical companies if the present study is a very small risk of drugs, such as cold medicine, then there will be a number of insurance companies to actively accept their insurance. However, if the study is a greater risk of drug, then will face the embarrassment of exclusions. Reasons for this are very simple, the lack of strict legal guarantee, the insurance company can not afford such a big risk.
Was followed by monitoring for the risk of opening up could not be effectively controlled. In general, the multinational pharmaceutical giants in clinical trials conducted in a relatively standardized. But once the door wide open clinical trials, a variety of companies will flock, look forward to from a slice, in such circumstances, the current regulatory capacity of hard to easily absorb it. For example, current clinical trials for the cost of monitoring work is very difficult, which also makes a number of non-standard company "take the cost of clinical trials, the name of the actual trip to the doctor commission," can be achieved.
Third, innovation and enthusiasm of local businesses have yet to be inspired. Even though the field of clinical trials of drugs from the multinational pharmaceutical companies do clinical research inputs to get some benefits, but only in the R & D innovation in local enterprises the case of strong demand, the state will really consider opening up the pharmaceutical clinical research necessary.
Fourth, China has not yet fully grasp the clinical research skills. Although China has participated in a number of international multi-center clinical trials of drugs, but local researchers are seldom able to set foot in the early global clinical trial design, clinical trials of new drugs and therefore has yet to master the core technology. Some multinational pharmaceutical companies in China to obtain the test data, but also not fully disclosed to our researchers and management.
Hai-Bo Wu stressed, either from external demand, internal demand, or to compete with other developing countries from the point of view, all hope that China will soon open the door to clinical trials, but really want to achieve the "open", you need to government departments, businesses, hospitals and research institutions to work together.
Management should actively learn from the successful experience of developed countries, improve relevant laws and regulations, in the early realization of the system into line with the developed countries to ensure that the entire process of clinical trials, the effective protection of enterprises, research institutions and the interests of all subjects . At the same time, but also from the policies that encouraged local enterprises to innovate and to increase the establishment of clinical trials to shorten the processing time.
Hospitals are required to attach importance to clinical trials of new drugs in clinical trials of medical practitioners give more support, we must also work to ensure that test specifications.
Multinational corporations, you should attach importance to China's great power status, so that China's researchers to participate in clinical trials of the early design, and effectively help Chinese research institutions and Chinese enterprises to improve their R & D level, so that in the global drug R & D to play a greater role.