Open clinical trial institutions to further develop innovative drug research in China

Volkswagen innovation, and entrepreneurship has become a national development strategy. In the field of medicine, innovative medicines have received much attention from the industry. In order to ensure the provision of high-quality, low-price medical protection to the broad masses of the people, the innovation and innovation of innovative drugs is an important step. However, from the current point of view, there are still many problems in the field of innovative medicine in China, and clinical trials are one of the important aspects.

An innovative pharmaceutical company, for a research and development project, has five or six years to deal with clinical research institutions. According to industry, the clinical practice institutions that are too conservative in China have become a shortcoming that restricts innovation in the pharmaceutical industry. In contrast, the regulation of new drug clinical trials in the United States has increasingly shown an incentive to innovate. For example, in August 2018, the FDA issued a new draft guideline recommending that placebo-controlled trial designs should be used only in specific situations when designing cancer clinical trials.

An innovative drug research and development investment of tens of millions, hundreds of millions of dollars, in the clinical trials will take several years. According to the industry, the clinical trial institutions are no less important than the drug supervision, capital and research and development capabilities of innovative drugs, but the current domestic clinical trial hospitals can not keep up. “Innovation is inherently open and open, and clinical trial institutions should be more open.”

For pharmaceutical R&D practitioners, clinical trial institutions that can conduct new drug development trials are concerned with whether their research and development progresses smoothly. Nowadays, the approval speed of the pharmaceutical R&D administrative department has accelerated, and can the clinical trial institutions that meet the standards meet the current demand for new drug research and development?

The author has learned that in recent years, China has been continuously reforming its clinical trial institutions. For example, on November 7, Shanghai issued the “Implementation Opinions on Deepening the Reform of the Examination and Approval System to Encourage the Innovation of Pharmaceutical Medical Devices” (hereinafter referred to as the “Opinions”). The introduction of this policy will better solve the pain points of clinical trials.

According to the opinion, Shanghai will promote the development of clinical trial institutions, promote the record-keeping work of clinical trial institutions, encourage social forces to join the medical institutions to invest in the establishment of clinical trial institutions, and strive to achieve more than 80 clinical trial institutions in the city to achieve full coverage of clinical specialties.

It is understood that this opinion also calls for further improvement of the medical staff innovation environment, and encourages clinicians to carry out and participate in drug medical device technology innovation activities based on practical experience.

Under the framework of the Shanghai industry classification and regulation performance salary total policy, improve the income distribution incentive mechanism of medical institutions, guarantee the income level of clinical trial researchers, and consider the clinical trials initiated by researchers as scientific research projects into scientific research performance evaluation. Establish incentives for clinical trial institutions and research teams, rewards for scientific and technological achievements, income from personnel for scientific research projects obtained through open bidding, and the introduction of high-level talents and teams, etc., not included in unit performance Total wages. Clinical trial researchers and related personnel are treated equally with clinicians in terms of job promotion and promotion of professional titles, and the performance of clinical trials is an important part of the evaluation of professional titles. The multi-center clinical trial conducted as the lead unit can be regarded as a provincial-level project.

Strengthening innovation in clinical trials is also an important step for the development of innovative medicines. With the continuous opening, reform and innovation of clinical trial institutions, the development of innovative drugs in China will also open up new developments. The author was informed that in recent years, a number of pharmaceutical companies have been approved for clinical trials.

For example, on December 4, Hengrui Pharmaceutical announced that the company and its subsidiary Shanghai Hengrui Pharmaceutical Co., Ltd. will conduct phase III clinical trials of SHR-1316 injection in the near future. On the afternoon of November 15, Galaxy Bio announced that the company's wholly-owned subsidiary Nanjing Yinhe Biotechnology Co., Ltd. and Shuangliang Group's Wuxi Shuangliang Biotechnology Co., Ltd. jointly submitted a new third-generation EGFR inhibitor drug clinical trial application. On November 15, 2018, it was accepted by the State Drug Administration for review and received the Notice of Acceptance.

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China has become the world's largest producer of Antipyretic And Analgesic drugs. The output of aspirin, paracetamol, analgin and other varieties has exceeded 10,000 tons, and the output of phenacetin, aminopyrine, antipyrine and other varieties has exceeded 1,000. Ton. At present, the output of Antipyretic analgesics in my country is growing rapidly, and it is expected to grow at a rate of about 8% in the future. The production of intermediates for antipyretic and analgesic drugs is large, and there are many manufacturers. With the growth of antipyretic and analgesic drugs, their intermediates have also developed by leaps and bounds.
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