Medical Device Clinical Trial Management System Reform Speeds Up | Conversion Still Needs Patience

Medical Network May 15th Recently, the "2018 Medical Device Clinical Trial Seminar" sponsored by the National Medical Device Industry Technology Innovation Alliance and the China Medical Device Industry Association Innovation Service Professional Committee was held in Beijing. It was from the medical device regulatory agency. Clinical trials Experts and practitioners from institutions, medical device companies and consulting agencies exchanged and shared opportunities and challenges brought about by the reform of the medical device clinical trial management system.

The reporter learned from the interview that this seminar is just a microcosm of the clinical research trials of medical devices. The recent industry’s high concern for clinical trials stems from a series of favorable policies at the national level.

Since 2017, regulations and guidance documents of the medical device industry have been intensively introduced. Among them, the China Office and the State Office issued in October 2017 “the encouragement of deepening the review, review, and approval system reforms. drug The "Opinions on Innovative Medical Devices" (hereinafter referred to as the "Innovative Opinions") clearly stated that the clinical trial institutions accredited to implement record management, accepting data from overseas clinical trials, and severely investigating data falsification behavior and other eight clinical trial management reform measures were praised by the industry as Is a document that has the greatest impact on China's medical device clinical trials.

In order to implement the State Council's policy of decentralization, decentralization, integration, and optimisation of service, the national drug regulatory authorities also successively issued supporting documents such as the “Measurement and Filing Regulations for Medical Device Clinical Trial Organizations”.

The relevant person of the National Medical Device Registration Department disclosed in the speech at this seminar that for a long time, China's medical device clinical trial institutions have been using drug clinical trial institutions to conduct clinical trials. As of October 2017, it has the qualification of a drug clinical trial institution. There are only 600 medical institutions and most of them are concentrated in the top three hospital , can not meet the needs of clinical trials of medical devices. In the case of relatively high pressure in the Outpatient Department of the top three hospitals, some medical equipment with low risk levels enter the top three hospitals for clinical trials is not realistic. With the "medical equipment clinical trial institution conditions and filing The "Administrative Measures" was issued to relax the qualifications of medical device clinical trial institutions to Dimethyl Hospital. Only the third category of medical devices requiring clinical trial approval was undertaken. The top three hospitals undertook clinical trials, which is expected to solve the scarcity of resources for medical device clinical trial institutions. Puzzles.

As of the end of April 2018, 87 medical institutions have completed the record, of which 65 are original drug clinical trial bases and 22 are new medical device clinical trial institutions. There will still be a considerable number of drugs and medical devices that have never been launched in the future. Medical institutions in clinical trials join the industry through record filing.

On July 31, 2017, the national drug regulatory authorities interpreted the issues related to the “Quality Management Practice for Medical Device Clinical Trials”.

In January 2018, the National Drug Regulatory Agency issued the "Guiding Principles for the Design of Medical Device Clinical Trials" and "Technical Guidelines for the Acceptance of Medical Device Overseas Clinical Test Data" to give scientific guidelines for the clinical trials of Chinese medical devices.

On March 29th, the Center for Medical Device Evaluation held a public welfare training program for guiding the clinical trials of medical devices in Beijing. It conducted special lectures on how medical device companies should carry out clinical trials in accordance with regulations and complete high-quality registration applications.

On April 18, the National Drug Regulatory Agency re-interpreted the issues concerning the “Quality Management Practice for Medical Device Clinical Trials”.

On April 26, the Medical Device Evaluation Center opened a 'Q&A for medical device clinical trials' column in its WeChat public number 'China Audit', which answered questions on the representative issues collected during the training.

The reporter combed and found that, in fact, the drug regulatory department has always been concerned about the problems existing in the implementation of the "Quality Management Practice for Medical Device Clinical Trials" and started with the details to promote the development of the medical device industry. According to the "Innovative Opinion" and other relevant documents In addition to positively guiding the sponsors, the national drug regulatory agency has standardized the clinical trials of medical devices, and has also actively organized random inspections of the clinical trial data. Statistics show that in 2017, the national drug regulatory authorities conducted a random inspection of 19 clinical trials. 3. The pilot project found that 3 projects were unqualified and were given public information and not registered.

Qi Teng medicine – Deng Xiaoyu, Asia-Pacific business director at Corvins, believes that a series of regulatory initiatives that focus on clinical trial quality management will help improve the R&D capabilities of manufacturing companies, and in turn foster national enterprises with international competitiveness. medical instruments Industry transformation and upgrading. 'The future, looking forward to more China enterprise Launched global multi-center clinical trials and embarked on the international stage with an equal attitude. '

Under the influence of a series of favorable policies, the “spring” of medical device clinical trial management appears to have also come. However, Li Qiang, general manager of Guangzhou Jiutai Medicinal Machinery Technology Co., Ltd. reminded: “The policy needs to be realized as a dividend, and there are some specific issues. Need to solve. For example, to further improve the enthusiasm of medical institutions to participate in the clinical trials of medical devices, solve the problem of shortage of medical equipment professionals, etc. '

According to the "Measures for the Management and Registration of Medical Device Clinical Trial Institutions", the filing system will be implemented on January 1, 2018. To ensure the continuity of clinical trials, from January 1, 2018 to December 31, 2018 The medical device clinical trial sponsor can continue to select drug clinical trial institutions to conduct clinical trials. However, since January 1, 2019, clinical trial sponsors of medical devices (including in vitro diagnostic reagents) can only select medical records that have been registered in the filing system. Equipment clinical trial institutions. At present, there are about half a year from the end of the transitional period, and there is still a gap between the number of medical institutions registered and the actual demand.

'This may be related to the low participation enthusiasm of some medical institutions.' For example, Li Qiang said that each lung cancer patient can only participate in one clinical trial. If he participated in clinical trials of medical devices, he can no longer participate in drug clinical trials. And at present, The cost of investigators in medical device clinical trials is only about half of the drug clinical trials. 'So, medical institutions are more willing to pay attention to the relatively high cost of drug clinical trials, and a small number of leading-edge products (medicine and medical devices), rather than Willing to undertake medical device clinical trials with relatively low technological content and relatively low cost.

In addition, since medical device clinical trials involve multiple disciplines such as equipment, statistics, testing, clinical medicine, clinical epidemiology, and evidence-based medicine, it is sometimes difficult to avoid the presence of statisticians who only talk about statistics. Inspectors are only talking about the drawbacks of testing. Therefore, increasing The cultivation of medical device professionals is particularly urgent, and the cultivation of talents and the transformation of policies will take time. Fortunately, at present Shanghai Medical College has established an undergraduate medical device management specialty, Harbin Medical University, Guangdong Medical University, Guangzhou Medical College Universities, Southern Medical University, Binzhou Medical College and other medical universities have also established undergraduate majors in biostatistics.

'I look forward to China's medical device clinical trial industry as soon as possible with international standards, to achieve high-quality development.' Li Qiang said.