The Reform Of Drug And Equipment Examination And Approval Has Been Strengthened, And The Implementation Of "Real World Evidence" Has Been Accelerated

At the beginning of this year, China's State Drug Administration (nmpa) issued the No.1 New Year's notice on Issuing real world evidence to support drug research, development and evaluation (Trial Implementation) (hereinafter referred to as the guiding principles), which set a new direction for the reform of drug and equipment review and approval this year.

Real world evidence (RWE) refers to the clinical evidence about drug use and potential benefit risk obtained through proper and adequate analysis of applicable real world data. Real world data can be used not only to support drug R & D and regulatory decisions, but also for other scientific purposes.

On March 26, the State Food and Drug Administration approved the registration of "glaucoma drainage tube" of aierjian company, becoming the first medical device product approved to be listed using domestic real world data.

In the past, the positioning of real-world evidence was mainly to meet the regulatory requirements related to drug safety after marketing. Today, its application has gone far beyond the scope of pharmacovigilance, and has been widely used in different stakeholders in the medical and health industry. The promulgation of the "guiding principles" is in line with the reform of drug and equipment review and approval, and timely catch up with this train. How to use the real world evidence to speed up the listing of pharmaceutical equipment has become a new "sharp weapon" for the strategic difference positioning of enterprises.

From "dispensable" to "indispensable"

In recent years, the speed of R & D and higher quality of domestic drug are required. How to use real-world evidence to evaluate the effectiveness and safety of drugs is thus pushed to the front.

Real world research (RWR / RWS) refers to the research process of collecting data related to the health of the research subjects in the real world environment or based on the collected data derived from these data to obtain the clinical evidence of drug use and potential benefit risk through analysis for preset clinical problems. Real world data (RWD) refers to the data collected daily and related to patients' health status and / or diagnosis and health care.

The guiding principles also provide some application scope, but not limited to the following areas, such as providing evidence of effectiveness and safety for the registration and listing of new drugs; providing evidence for the change of the instructions of marketed drugs; and providing evidence for post marketing requirements or re evaluation of drugs.

How to ensure the implementation of research and development achievements in the post epidemic era, ensure the safety of clinical application of innovative drugs, real world data and other new policies have become the layout highland of many multinational medical enterprises.

"The future is a digital world, and the vast amount of data in the medical field has guiding value," Zhang Mingdong, chief medical officer of Boston science Asia Pacific region and vice president of medical affairs and health economics, told 21st century economic report

There will be more and more medical data, including not only electronic medical records, but also health monitoring data of patients through various intelligent wearable devices. "A large number of active health surveillance data are also part of the real world data," Zhang explained. How to make full use of and excavate these massive data, produce valuable evidence as a medical guide, guide product supervision, medical insurance decision-making and healthy lifestyle of patients, which is the general trend of medical development in the future

Industry university research cooperation accelerated

In order to promote the reform of China's medical device review and approval system and explore the application of clinical real world data for medical device registration, in June 2019, the State Food and Drug Administration and Hainan Provincial Government jointly launched the Hainan clinical real world data application pilot work. Aierjian's glaucoma drainage tube is the first pilot and listed product to "eat" the policy bonus. It uses clinical real world evidence to evaluate the ethnic differences in registration, which is the first product approved by this way in China.

In October 2019, according to the public data of the pilot area of Boao Lecheng, Hainan, it is pushing forward to build a Boao research hospital with a total planned bed number of 500 beds and an area of about 145 mu, as the national real world clinical data research center.

In April 2020, the real world data research and innovation center was established. Device manufacturer Boston science has launched the world's first disposable duodenoscopy exalt model d real world data research.

Zhang Mingdong said that the benefits brought by real world data research are very obvious. First, advanced drugs and devices can be used as supplementary data through real world data to speed up the approval and post marketing product supervision. The second is to support the expansion of indications. "No separate clinical trials were conducted, but studies of real-world data in the system were used to generate evidence to support the approval of indications." Third, it is used for post marketing product monitoring.

On July 3 this year, aierjian cooperated with Shanghai No.9 hospital and Boao super hospital to launch qiaoyadeng scale landing and clinical data collection. This is another time that eljian uses the "weapon" of real world data to guide relevant clinical medical research and decision-making.

In addition to enterprises, more and more research institutions have joined this "trend".

On July 6, iqvia AI kunwei signed a contract with the education development foundation of Fudan University and the school of public health of Fudan University. The two sides reached a strategic cooperation to cultivate high-level research talents in related fields and jointly promote the discipline development and application of domestic health technology assessment, health economics and real-world research.

On July 10, the real world data research academic exchange training meeting was held in Boao Le City. Zhao Jin, chief staff member of Hainan Provincial Drug Administration, said that the provincial drug administration will continue to promote the second batch of pilot work of medical devices in the next step.

Talent and data problems to be solved

From health technology assessment, health economics to real world research, and from government decision-making level to enterprises, attention and recognition are getting higher and higher. However, the construction of human resources and high-quality data has just begun with this policy.

"Decision making departments, from the state medical insurance bureau to the National Health Commission, have a high recognition of assessment tools such as health technology assessment and health economics." "This is an important step forward for the scientific and systematic assessment of new product health insurance access," Xie Yang, head of iqvia's Greater China health economy and real world evidence, told 21st century economic report

At the same time, there are obvious shortcomings in finding talents who can skillfully use these assessment tools.

"First, this field was relatively unpopular before. Only a few colleges and universities in China were cultivating relevant talents, with a small number," Xie Yang said. "The second is the problem of hands-on ability: students have insufficient hands-on research on how to build models and how to design the real world."

In addition, the quality and standardization of real-world data is a big challenge in China. How to ensure high-quality data is also an issue of great concern to regulators.

"We don't have to emphasize the rigor and the quality of the evidence, because we don't have to emphasize the quality of the evidence." Xie Yang believes that at present, there is still a lack of data governance in China, "this is like the process of growing vegetables, washing vegetables and frying vegetables. How to clean and get clean and accurate data for analysis and research is one of the important challenges in the real world research and development path

Whether it is a multinational pharmaceutical enterprise or a local pharmaceutical enterprise, many enterprises are paying attention to it after the introduction of the guiding principles this year. "In the next year or two, you may see more cases appear, and enterprises need to make more investment and preparation, including research and talent team building." Xie Yang thinks.

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