In recent years, multinational pharmaceutical companies have constantly moved new drug R&D centers to China and implemented a global strategy for the simultaneous development of drugs. In order to change the unfavorable situation of transnational corporations leading the international multi-centered R&D structure, change “Made in China†to “created in Chinaâ€, develop the national pharmaceutical industry, and encourage independent innovation, we must standardize drug clinical trials. This is a solid foundation for scientifically evaluating innovative drugs and ensuring the safety and effectiveness of listed drugs.
Clinical trials of new drugs are areas where science, ethics, and commercial interests are intertwined and intricate. In recent years, with the strengthening of the independent innovation capability of the pharmaceutical industry in China, clinical trials have become increasingly important in China's pharmaceutical industry. Official data from the SFDA showed that in 2010, China approved a total of 916 "new drugs" for clinical trials, an increase of 111% compared with 434 in 2008. Data from unofficial sources indicate that the clinical trials of hundreds of new drugs each year involve approximately 500,000 people.
However, there are serious problems hidden behind the huge population of new drug clinical trials. In March this year, a patient who was found to be taking Pfizer's anti-cancer drug "Suttan" died and the suit was finally decided after four years. The court awarded Pfizer compensation to the family of the patient for $300,000. The ruling also pushed the problems in clinical trials to the point of public opinion once again.
Compared with Europe, the United States, Japan and other countries, the cost of trial drugs in China is relatively low, while China has a large population and a large number of diseases. In addition, most of the Chinese patients are poor and there are no other drug components in the body, so the best results can be obtained. And China's pharmaceutical market is huge, and early trials will help get approval for listing in China as soon as possible. Therefore, more and more multinational companies have been conducting experiments in China in recent years.
In fact, conducting clinical trials in our country is not a bad thing. According to Zeng Fandian, member of the International Union of Pharmacology (IUPHAR) Developing Countries Clinical Pharmacology Branch, “This is conducive to the Chinese medical community in line with the world. Once these drugs are approved for marketing, Chinese patients can use the most advanced drugs at the first time. ."
In addition, the “Twelfth Five-Year Plan for the Development of Medical Science and Technology†and the “Twelfth Five-Year Plan†for the Development of the Pharmaceutical Industry have all set the tone for the new drugs that have been released recently. There are more than 200 approvals for various types of approvals, including more than 100 certificates for new drugs, veterinary drugs, and medical device certificates. However, such a huge goal also considers all aspects of the current clinical trials of new drugs in China.
The status of clinical trials of new drugs in China:
Overall backward
Clinical research is one of the important links in R&D of pharmaceutical innovation. From the perspective of the distribution of new drug R&D funds in the global pharmaceutical field, the investment in the clinical research phase has accounted for two-thirds of the R&D investment funds for new drugs, which is the core stage of capital investment. However, the cost of research and development of new drugs continues to rise, but the output is getting harder and harder, and the risk of clinical trials is getting higher and higher. China's current generic pharmaceutical manufacturing companies account for the majority, and in the short term have no ability and intention to invest in clinical research; local innovative companies are conscious of strengthening clinical trials, but lack of funds and experience, lack of guidance and training; bases for drug clinical trials are few and basically In large cities, most of the new-onset people are in rural areas, and there are not many hospitals that can conduct drug clinical trials, leading to higher costs. Therefore, there are fewer clinical trial institutions that can specifically conduct clinical trials of new drugs in China.
Since 1998, the Ministry of Public Health and the State Bureau have promulgated the “GCP Quality Control Practices†(GCP) and a series of supporting regulations. At present, 333 clinical trial institutions have passed qualification accreditation and 208 have qualifications for clinical trial inspectors. . However, the professional full-time research team construction of China's clinical trial institutions still lags behind; investment in facilities and equipment construction is insufficient, technical support is not in place, and clinical trials cannot be met; quality management systems are not perfect, quality control and quality assurance measures are not implemented; Ethical committees have insufficient capacity for ethical review. Especially in the phase I clinical trials, the ability to participate in the design of clinical trials for innovative drugs and the ability to control risk in the course of clinical trials is weak. This is currently the most prominent issue.
There have been industry insiders who have described the difference between China's clinical trials and foreign countries. “Foreign drug trials are like a 'funnel', so they enter the phase I clinical trial very easily. When phase III trials are completed, only 20 are left. About %, the elimination rate of nearly 80%. And China's new drug clinical review is like a 'tube barrel', the phase I clinical trials is very difficult, once you can enter the end, the passing rate of almost 100%."
In recent years, the problem of drug safety in our country has occurred from time to time. The clinical trial of new drugs is an important consideration for drug safety. On December 6, 2011, the National Quality Supervision Conference on Drug Clinical Trials, co-sponsored by the Ministry of Health and the State Food and Drug Administration, was held in Beijing. The conference pointed out that scientifically, objectively and effectively evaluating innovative drugs is one of the important measures to support the creation of “major innovation drugs†and serve the construction of an innovative country. The State Bureau will innovate the mechanism, strengthen supervision and control, Not tolerated. However, there is no mention of specific control methods for discovering frauds in clinical trials.
In January of this year, the State Council issued the Twelfth Five-Year Plan for National Drug Safety (hereinafter referred to as the “Planningâ€), aiming to improve the level of drug safety in China through a comprehensive process. The "Planning" proposes that in the next five years, a non-clinical safety evaluation laboratory for drugs, a supervision and inspection system for pharmaceutical clinical trials, and a regulatory mechanism will be established to improve the on-site inspection coverage of drug clinical trials and to strengthen the monitoring of safety data for clinical trials.
Because clinical trials require a lot of manpower and material resources, most pharmaceutical companies pass clinical trials to CRO, a pharmaceutical service outsourcing company, to coordinate the clinical trials of drug clinical trial institutions and process analytical test data. However, China has a large number and small scale of CROs. Due to fierce competition, it adopts a low-cost operating model, lagging behind equipment, low technology, lack of awareness of intellectual property protection, and lacks complete systems and processes to guarantee the quality and progress of implementation projects. Clinical trials team to organize the implementation of clinical trials.
Global multi-center clinical trials:
Opportunities and obstacles
In addition to more and more multinational companies transferring clinical trials to China, clinical trial institutions have also put their perspectives on China.
In 2010, multinational CRO Inc. ICON and Tianjin Taixin-Fangen Laboratory reached a cooperation to jointly establish a central laboratory. The laboratory has passed certifications and inspections from global professional organizations such as the American Pathology Association (CAP) and has recently undertaken nearly 10 clinical research projects in each phase in the world.
Shortly after this, Intertek Group, one of the world's largest industrial and consumer product inspection companies, announced that its third-party medical testing center will be operational in Shanghai.
However, the current domestic clinical trials still rarely use the central laboratory, for two reasons. First, domestic clinical trials do not require high quality data. Second, the cost of the central laboratory is relatively high. At least logistics costs must be considered.
As the largest developing country, China also has an important strategic position in the global drug development chain. Analysis of the industry, the establishment of these laboratories was precisely because of the rapid growth of China's clinical trials. With the choice of multinational pharmaceutical giants to establish a central clinical laboratory in China and conduct multi-center clinical trials, this is an important opportunity to increase the level of Chinese pharmaceutical R&D and clinical research. Standardizing drug clinical trials is a solid foundation for scientifically evaluating innovative drugs and ensuring the safety and effectiveness of listed drugs; it is a powerful guarantee for improving innovation capabilities and successfully implementing major special projects. The cooperation of global multi-center clinical trials is conducive to China's ability to attract outstanding clinical trials from abroad, to facilitate the integration of Chinese medicine with the world, to change “Made in China†to “Created in China,†to develop the national pharmaceutical industry, encourage independent innovation, and integrate international new drug research and development. In the queue.
However, international multi-center drug clinical trials are facing a unique threshold in China, which is extremely unfavorable for China to undertake the transfer of drug R&D industry. For example, the speed of approval is slow. Up to 6 to 9 months of review time limit has prevented many international multi-center trials; for early clinical trials (phase I), overseas trials are conducted for clinical trials for the protection of subjects. The drugs must be registered or have entered Phase II or Phase III trials, making it difficult for China to lead the world in drug development. (Text / Liao Hui)
Clinical trials of new drugs are areas where science, ethics, and commercial interests are intertwined and intricate. In recent years, with the strengthening of the independent innovation capability of the pharmaceutical industry in China, clinical trials have become increasingly important in China's pharmaceutical industry. Official data from the SFDA showed that in 2010, China approved a total of 916 "new drugs" for clinical trials, an increase of 111% compared with 434 in 2008. Data from unofficial sources indicate that the clinical trials of hundreds of new drugs each year involve approximately 500,000 people.
However, there are serious problems hidden behind the huge population of new drug clinical trials. In March this year, a patient who was found to be taking Pfizer's anti-cancer drug "Suttan" died and the suit was finally decided after four years. The court awarded Pfizer compensation to the family of the patient for $300,000. The ruling also pushed the problems in clinical trials to the point of public opinion once again.
Compared with Europe, the United States, Japan and other countries, the cost of trial drugs in China is relatively low, while China has a large population and a large number of diseases. In addition, most of the Chinese patients are poor and there are no other drug components in the body, so the best results can be obtained. And China's pharmaceutical market is huge, and early trials will help get approval for listing in China as soon as possible. Therefore, more and more multinational companies have been conducting experiments in China in recent years.
In fact, conducting clinical trials in our country is not a bad thing. According to Zeng Fandian, member of the International Union of Pharmacology (IUPHAR) Developing Countries Clinical Pharmacology Branch, “This is conducive to the Chinese medical community in line with the world. Once these drugs are approved for marketing, Chinese patients can use the most advanced drugs at the first time. ."
In addition, the “Twelfth Five-Year Plan for the Development of Medical Science and Technology†and the “Twelfth Five-Year Plan†for the Development of the Pharmaceutical Industry have all set the tone for the new drugs that have been released recently. There are more than 200 approvals for various types of approvals, including more than 100 certificates for new drugs, veterinary drugs, and medical device certificates. However, such a huge goal also considers all aspects of the current clinical trials of new drugs in China.
The status of clinical trials of new drugs in China:
Overall backward
Clinical research is one of the important links in R&D of pharmaceutical innovation. From the perspective of the distribution of new drug R&D funds in the global pharmaceutical field, the investment in the clinical research phase has accounted for two-thirds of the R&D investment funds for new drugs, which is the core stage of capital investment. However, the cost of research and development of new drugs continues to rise, but the output is getting harder and harder, and the risk of clinical trials is getting higher and higher. China's current generic pharmaceutical manufacturing companies account for the majority, and in the short term have no ability and intention to invest in clinical research; local innovative companies are conscious of strengthening clinical trials, but lack of funds and experience, lack of guidance and training; bases for drug clinical trials are few and basically In large cities, most of the new-onset people are in rural areas, and there are not many hospitals that can conduct drug clinical trials, leading to higher costs. Therefore, there are fewer clinical trial institutions that can specifically conduct clinical trials of new drugs in China.
Since 1998, the Ministry of Public Health and the State Bureau have promulgated the “GCP Quality Control Practices†(GCP) and a series of supporting regulations. At present, 333 clinical trial institutions have passed qualification accreditation and 208 have qualifications for clinical trial inspectors. . However, the professional full-time research team construction of China's clinical trial institutions still lags behind; investment in facilities and equipment construction is insufficient, technical support is not in place, and clinical trials cannot be met; quality management systems are not perfect, quality control and quality assurance measures are not implemented; Ethical committees have insufficient capacity for ethical review. Especially in the phase I clinical trials, the ability to participate in the design of clinical trials for innovative drugs and the ability to control risk in the course of clinical trials is weak. This is currently the most prominent issue.
There have been industry insiders who have described the difference between China's clinical trials and foreign countries. “Foreign drug trials are like a 'funnel', so they enter the phase I clinical trial very easily. When phase III trials are completed, only 20 are left. About %, the elimination rate of nearly 80%. And China's new drug clinical review is like a 'tube barrel', the phase I clinical trials is very difficult, once you can enter the end, the passing rate of almost 100%."
In recent years, the problem of drug safety in our country has occurred from time to time. The clinical trial of new drugs is an important consideration for drug safety. On December 6, 2011, the National Quality Supervision Conference on Drug Clinical Trials, co-sponsored by the Ministry of Health and the State Food and Drug Administration, was held in Beijing. The conference pointed out that scientifically, objectively and effectively evaluating innovative drugs is one of the important measures to support the creation of “major innovation drugs†and serve the construction of an innovative country. The State Bureau will innovate the mechanism, strengthen supervision and control, Not tolerated. However, there is no mention of specific control methods for discovering frauds in clinical trials.
In January of this year, the State Council issued the Twelfth Five-Year Plan for National Drug Safety (hereinafter referred to as the “Planningâ€), aiming to improve the level of drug safety in China through a comprehensive process. The "Planning" proposes that in the next five years, a non-clinical safety evaluation laboratory for drugs, a supervision and inspection system for pharmaceutical clinical trials, and a regulatory mechanism will be established to improve the on-site inspection coverage of drug clinical trials and to strengthen the monitoring of safety data for clinical trials.
Because clinical trials require a lot of manpower and material resources, most pharmaceutical companies pass clinical trials to CRO, a pharmaceutical service outsourcing company, to coordinate the clinical trials of drug clinical trial institutions and process analytical test data. However, China has a large number and small scale of CROs. Due to fierce competition, it adopts a low-cost operating model, lagging behind equipment, low technology, lack of awareness of intellectual property protection, and lacks complete systems and processes to guarantee the quality and progress of implementation projects. Clinical trials team to organize the implementation of clinical trials.
Global multi-center clinical trials:
Opportunities and obstacles
In addition to more and more multinational companies transferring clinical trials to China, clinical trial institutions have also put their perspectives on China.
In 2010, multinational CRO Inc. ICON and Tianjin Taixin-Fangen Laboratory reached a cooperation to jointly establish a central laboratory. The laboratory has passed certifications and inspections from global professional organizations such as the American Pathology Association (CAP) and has recently undertaken nearly 10 clinical research projects in each phase in the world.
Shortly after this, Intertek Group, one of the world's largest industrial and consumer product inspection companies, announced that its third-party medical testing center will be operational in Shanghai.
However, the current domestic clinical trials still rarely use the central laboratory, for two reasons. First, domestic clinical trials do not require high quality data. Second, the cost of the central laboratory is relatively high. At least logistics costs must be considered.
As the largest developing country, China also has an important strategic position in the global drug development chain. Analysis of the industry, the establishment of these laboratories was precisely because of the rapid growth of China's clinical trials. With the choice of multinational pharmaceutical giants to establish a central clinical laboratory in China and conduct multi-center clinical trials, this is an important opportunity to increase the level of Chinese pharmaceutical R&D and clinical research. Standardizing drug clinical trials is a solid foundation for scientifically evaluating innovative drugs and ensuring the safety and effectiveness of listed drugs; it is a powerful guarantee for improving innovation capabilities and successfully implementing major special projects. The cooperation of global multi-center clinical trials is conducive to China's ability to attract outstanding clinical trials from abroad, to facilitate the integration of Chinese medicine with the world, to change “Made in China†to “Created in China,†to develop the national pharmaceutical industry, encourage independent innovation, and integrate international new drug research and development. In the queue.
However, international multi-center drug clinical trials are facing a unique threshold in China, which is extremely unfavorable for China to undertake the transfer of drug R&D industry. For example, the speed of approval is slow. Up to 6 to 9 months of review time limit has prevented many international multi-center trials; for early clinical trials (phase I), overseas trials are conducted for clinical trials for the protection of subjects. The drugs must be registered or have entered Phase II or Phase III trials, making it difficult for China to lead the world in drug development. (Text / Liao Hui)
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