The reform of the management system of medical device clinical trials needs patience to speed up the transformation

Recently, the "2018 Medical Device Clinical Trial Seminar" hosted by the National Medical Device Industry Technology Innovation Alliance and the China Medical Device Industry Association Innovation Services Professional Committee was held in Beijing, where experts and practitioners from medical device regulatory agencies, clinical trial institutions, medical device enterprises and advisory bodies exchanged and shared the opportunities and challenges brought about by the reform of the medical device clinical trial management system.
reporters in the interview learned that this seminar is only a microcosm of the medical device clinical trial research boom, the recent industry's high attention to clinical trials, are derived from a series of good policies at the national level.system untiedsolve the problem of clinical resources
since 2017, medical device industry regulations and guidance documents have been issued intensively. Among them, the "Opinion on Deepening the Reform of the Review and Approval System to Encourage Drug Medical Device Innovation" (hereinafter referred to as "Innovation Opinion"), issued by the Central Office and the State Office in October 2017, clearly puts forward eight clinical trial management reform measures, such as the qualification of clinical trial institutions to implement record management, accept overseas clinical trial data, and seriously investigate and punish data fraud, which has been hailed by the industry as the document with the greatest impact on china's medical device clinical trials.
in order to implement the spirit of decentralization, decentralization and optimization of services under the State Council, the State Drug Administration has also issued supporting documents such as the Conditions of Clinical Trial Institutions for Medical Devices and the Measures for the Administration of The Record.
relevant people from the National Medical Device Registration Department of China said in a speech at this seminar that for a long time, China's medical device clinical trial institutions have been borrowing drug clinical trial institutions to conduct clinical trials. As of October 2017, there were only over 600 medical institutions qualified as drug clinical trial institutions, most of which were concentrated in triple-A hospitals and could not meet the clinical trial needs of medical devices. In the case of high outpatient pressure in Sanjia Hospital, some medical devices with low risk level are not realistic to enter Sanjia Hospital for clinical trials. With the publication of the Measures for the Administration of Clinical Trial Institutions and Records of Medical Devices, the qualification of medical device clinical trial institutions has been relaxed to the second-class hospitals, requiring only the third type of medical devices that require clinical trial approval, and the clinical trials undertaken by the three-A hospitals are expected to solve the problem of scarce resources of medical device clinical trial institutions.
end of April 2018, 87 medical institutions had completed filings, 65 of which were original drug clinical trial bases and 22 were new medical device clinical trial facilities. In the future, a significant number of medical institutions that have never conducted clinical trials of drugs and medical devices will join the industry through filing.the details ofto promote the transformation and upgrading of the industry
On July 31, 2017, the state drug regulatory authorities interpreted the relevant issues of the Code of Quality Management for Clinical Trials of Medical Devices.
January 2018, the State Drug Administration issued the Guidelines for the Design of Clinical Trials of Medical Devices, the Technical Guidelines for Accepting Data from Overseas Clinical Trials of Medical Devices, and gave scientific guidance to clinical trials of medical devices in China.
March 29, the Medical Device Technology Review Center held a public service training course on the guiding principles of medical device clinical trials in Beijing to teach medical device enterprises on how to conduct clinical trials in accordance with the law and complete the registration declaration in a high-quality way.
April 18, the State Drug Administration again interpreted the issues related to the Code of Quality Management of Clinical Trials of Medical Devices.
April 26, the Medical Device Technology Review Center opened a "Medical Device Clinical Trial Answers" column in its WeChat Public Number "China Device Review" to answer questions on the representative questions collected during the training.
reporter combed found that, in fact, the drug regulatory authorities have been concerned about the "medical device clinical trial quality management norms" in the implementation of the problems, and from the nuances, to promote the development of the medical device industry. According to the "Innovation Opinion" and other relevant documents, the state drug regulatory authorities in addition to leading the bid, medical institutions to regulate the conduct of medical device clinical trials, but also actively organize the authenticity of clinical trial data spot checks. Statistics show that in 2017, the state drug regulatory authorities conducted spot checks on 19 clinical trial projects and found that 3 projects were not qualified, respectively, to give open information and non-registration treatment.
deng Xiaoyu, Asia Pacific business director of qiteng Pharmaceuticals-Coventry, believes that a series of regulatory initiatives with clinical trial quality management as the focus are conducive to enhancing the research and development capabilities of production enterprises, thereby fostering internationally competitive national enterprises and promoting the transformation and upgrading of the medical device industry. "In the future, we look forward to more Chinese companies conducting multi-center clinical trials around the world and taking to the international stage on an equal footing."policy realization still need to work together
under the influence of a series of good policies, medical device clinical trial management "spring" seems to have arrived. However, Li Qiang, general manager of Guangzhou Jiutai Pharmaceutical Technology Co., Ltd., reminded: "There are some specific problems that need to be solved if the policy is to be cashed in as a dividend." For example, to further enhance the enthusiasm of medical institutions to participate in clinical trials of medical devices, to solve the shortage of medical device professionals and so on. The
shall come into effect on January 1, 2018 in accordance with the Regulations on the Conditions and Filing Of Clinical Trial Institutions for Medical Devices. To ensure the continuity of clinical trials, from January 1, 2018 to December 31, 2018, medical device clinical trial candidates can continue to select drug clinical trial institutions to conduct clinical trials, but as of January 1, 2019, medical device (including in-body diagnostic reagents) clinical trial candidates can only select medical device clinical trial institutions that have been documented in the filing system. At present, there is still about half a year to go until the end of the transition period, and there is still a gap between the number of filing medical institutions and the real needs.
" may be related to the low level of enthusiasm for participation in some medical institutions. Li Qiang, for example, can only participate in one clinical trial per lung cancer patient. If you participate in a medical device clinical trial, you can no longer participate in a drug clinical trial. Currently, researchers in medical device clinical trials cost only about half as much as drug clinical trials. "As a result, healthcare organizations are more likely to focus on relatively expensive drug clinical trials, as well as a handful of technology-leading cutting-edge products (drugs and medical devices), rather than on lower-tech, relatively low-cost medical device clinical trials."
Moremore, since clinical trials of medical devices involve devices, statistics, testing, clinical medicine, clinical epidemiology, evidence-based medicine and other disciplines, sometimes it is inevitable that statisticians only speak statistics, testing personnel only talk about the shortcomings of testing. Therefore, it is particularly urgent to increase the training of medical device professionals, and the training of talents and the transformation of policies need time. Happily, at present, Shanghai Medical College has established undergraduate medical device management major, Harbin Medical University, Guangdong Medical University, Guangzhou Medical University, Southern Medical University, Binzhou Medical College and other medical universities have also set up biostatical undergraduate major.
" look forward to China's medical device clinical trial industry as soon as possible in line with international standards, to achieve high-quality development. Li Qiang said. (China Medical Journal)