The first report of "chronic obstructive pulmonary disease" was released to create "data center" for real world research

Wen Jie Yang Xue "The comprehensive scientific research data of COPD patients from admission to discharge to follow-up is an important basis for analyzing the safety, effectiveness and pharmacoeconomic value of various drugs in the real world." Yang Ting, director of the respiratory department of China Japan Hospital, said at the 2019 summing up meeting of China chronic obstructive pulmonary disease classification diagnosis and treatment project held in Beijing However, the lack of diagnosis and treatment of COPD in China makes it difficult to collect scientific research data of COPD In 2018, under the initiative of Academician Wang Chen, the "chronic obstructive pulmonary disease project" was established by relying on the national respiratory disease Clinical Medical Research Center China respiratory specialist medical association Director Yang Ting pointed out that at present, 265 tertiary and secondary hospitals have participated in the special project of chronic obstructive pulmonary disease (COPD), covering the landmark hospitals of Western medicine and traditional Chinese medicine in various provinces and autonomous regions, and reported relevant data of nearly 10000 COPD cases In real world research, there are many kinds of real data (RWD) and a large number of them, but real world evidence (RWE) is rare Due to some key deficiencies in the level of hospital informatization in China, it is very difficult to transform a large number of single dimension RWD into RWE For all parties, "copn" provides a solid "data bank" for the follow-up research data value mining Zhang Yaowen, medical director of the association, said: "through the special project of chronic obstructive pulmonary disease (COPD) and the national collaborative network of clinical research on respiratory diseases, higher quality and more reliable real world evidence will be produced These data will provide great help to the government, medical institutions, patients, pharmaceutical enterprises, etc., and have positive social significance and economic value." First of all, through the special project of COPD, we can more effectively understand the risk factors, etiology and pathogenesis of COPD in China, which is of great significance for regional policy-making, disease mapping and new drug research and development; Second, evaluate the benefits and risks of clinical diagnosis and treatment for patients with COPD, carry out the comparative study on the efficacy of Chinese and Western medicine in natural population, and conduct a more comprehensive evaluation on the effectiveness, safety, medication plan and economic benefits of drugs and medical devices (such as respirators) in the field of respiration; Third, in the process of diagnosis and treatment of COPD, we should explore the best treatment plan of TCM through clinical medical evidence, so as to provide objective basis for the treatment of COPD by TCM and the combination of Chinese and Western medicine; Fourth, for drugs already on the market, it may be necessary to expand the indications after long-term clinical practice Especially in the field of children's medication and traditional Chinese medicine, there is a situation of medication beyond the specification in clinical practice Fifthly, it can answer the questions of standardized diagnosis and treatment, rational use of drugs, the impact of drug compliance on long-term prognosis of COPD patients, monitor the medical quality control, patient health management and other links, and put forward the optimization scheme, which provides the basis for the next stage of research and design Due to the long course of respiratory diseases, complex diseases and more patients distributed at the grass-roots level, the clinical data collection and scientific research cooperation of respiratory specialty need the coordination and cooperation of three-level and two-level hospitals, grass-roots hospitals and doctors In order to build a high-quality respiratory disease data platform, a single technical service can not meet the actual needs For this reason, the Medical Association has created a set of solutions for the whole life cycle of clinical research, and has been tested and improved in the practice of the special project of COPD The first is the scientific research and training of O2O Based on the powerful scientific research and education gene, in more than one year, CCPIT has carried out 19 off-line training for the special project of COPD, with an average of one scientific research training for this research every 2-3 weeks At the same time, it provides a special training platform on the website of the Medical Association, through which grassroots doctors can learn research programs and key points of data collection through the website or mobile terminal of the Medical Association, providing a solid foundation for high-quality scientific research data collection Doctors in clinical research are relatively controllable as variables, but the data are scattered in every link of clinical research, so it is impossible to guarantee the quality simply through human investment For this reason, the second step of the medical association is to provide data technology services The CCPIT has established a special scientific research cooperation network and data platform for COPD Through the design of scientific and reasonable data points with unified standards, the CCPIT has built an electronic data collection system to complete data collection and integration in a way of multi center cooperation, accumulate high-quality clinical research data, and let doctors get rid of the traditional paper-based and inefficient data collection and management methods "Through the scientific research cooperation network, the Chinese and Japanese hospitals, as the general center, can view the progress of each research center in the registered research project in real time, and help each research center solve problems in real time, and really establish a smooth two-way enabling cooperation mechanism," Zhang Yaowen said Even if the existing electronic data collection system has set up the data logic verification rules, and provides the source data collection solutions of image, audio and other modes, the clinical research data still needs medical supervision and verification In order to solve this problem, we will cooperate with professional cro to help doctors carry out clinical research data quality control From single point breakthrough to forming a full process solution covering clinical trials, and completing the overall layout of "scientific research education, scientific research big data, scientific research service", the medical association can effectively help researchers improve the efficiency of clinical research, and ensure high-quality data and analysis transformation In the field of clinical data research, fewer products are designed with doctors as the main body, and more clinical research products are designed for compliance of clinical trials As the designer, collector and researcher of clinical research data, doctors cannot play an important role Therefore, taking doctors as the core users, starting from the data source, the real world research "data center" guided by clinical research scenarios has become an effective solution In the way of severe vertical specialty, the medical caf é will combine a wide range of medical scenes with the production of scientific research data, establish a full life cycle clinical research platform, collect, integrate and manage high-quality real world data More importantly, in this sustainable data cycle, the high-level medical evidence generated is closely related to clinical diagnosis and treatment, which can truly achieve clinical research to improve clinical practice.