The latest release of CDE! These 12 real-world data can be used to generate real-world evidence.

Go from . . . On August 3rd, china's National Drug Administration's Drug Review Center (CDE) issued its latest notice: a notice of public consultation on the Guidelines for Real World Data for Real-World Evidence (Draft for Comments).
real-world data is the basis for producing real-world evidence, and high-quality, applicable real-world data is a prerequisite for producing real-world evidence.
, what sources of real-world data can be used to produce real-world evidence? The opinion draft points out that the sources of real-world data can be divided into hospital information system data, medical insurance payment data, disease registration data, public health monitoring data (such as drug safety monitoring, death information registration, out-of-hospital health monitoring), natural population queue data, etc., and the following are common real-world data sources classified according to data function types.
1. Hospital Information System Data Hospital Information System data includes structured and unstructured digital or non-digital patient records, such as patient demographic characteristics, clinical characteristics, diagnosis, treatment, laboratory examination, safety and clinical outcomes, usually stored in different information systems such as electronic medical records/electronic health files (EMR/EHR), laboratory information management systems (LIS), medical imaging archiving and communication systems (PACS), and radio information management systems (RIS).
some medical institutions in the data integration platform or clinical data center (CDR) on the basis of the establishment of hospital-level scientific research data platform, the integration of patient outpatient, inpatient, follow-up and other types of information, the formation of direct use in clinical research data.
some regional medical databases, which use a relatively centralized physical environment for the storage and processing of clinical data across medical institutions, have the characteristics of large storage volume and many types, and can also be used as a potential source of RWD.
information system data is based on the record of clinical practice process, covering a wide range of clinical outcomes and exposure variables, especially electronic medical records data in real-world research.
2. There are two main sources of medical insurance payment data in China, one is the basic medical insurance system established by the government and medical institutions, the establishment and unified management of the medical insurance payment database, including basic information about patients, medical service utilization, prescription, settlement, medical claims and planned health care and other structured fields of data.
is the commercial health insurance database, which is established by the insurance institution, and the data is classified as the insurance company claims payment and insurance term, and the data dimension is relatively simple.
health insurance system as a real-world data source, more used for health technology evaluation and drug economics research.
3. Registry Study data is an organized system that uses observational research methods to collect data from clinical and other sources that can be used to evaluate clinical outcomes for specific diseases, specific health conditions and exposed populations.
registration research according to the definition of the population characteristics of the study mainly include product registration, health service registration and disease registration three categories, China's registration research is mainly disease registration and product registration research.
, medical institutions and enterprises support product registration research, looking at cases of the use of a certain pharmaceutical product, focusing on the effects of their different adaptations or monitoring adverse reactions.
The advantage of the registration research database is that by integrating clinical diagnosis and treatment, medical insurance payment and other data sources, data collection is more standardized, generally including patient self-report data and long-term follow-up data, observation and outcome indicators are usually relatively rich, with high accuracy, strong structure, better population representation and other advantages, for the evaluation of drug effectiveness, safety, economy and compliance has a better applicability.
4. Active Monitoring Data on Drug Safety Active Monitoring Data On Drug Safety Active Monitoring Data are mainly used for drug safety research and drug epidemiological research, and data collection is carried out through national or regional drug safety monitoring networks from medical institutions, pharmaceutical companies, medical literature, online media, patient reporting outcomes, etc.
addition, safety monitoring databases for their own medicines established by medical institutions and enterprises themselves may also be part of such data sources.
5. Natural population cohort data Natural population cohort data refers to various data obtained through long-term forward-looking dynamic tracking observation of the general population or people with major diseases.
natural population cohort data with uniform standards, information sharing, long time spans, and large sample sizes can help model common disease risks and support precise target population targeting for drug development.
6. Histological data as an important support for precision medicine, including genomics, egegene, transcription, proteomics and metabolic groups and other data, these data from the perspective of system biology to depict the characteristics of patients in genetics, physiology, biology and so on.
usually histological data need to be combined with clinical data before it can become an applicable RWD.
7. Death Registration Data Population Death Registration is the continuous and complete collection and recording of death information by a State on its nationals.
currently has four systems for collecting information on deaths in China, which are affiliated with the National Center for Disease Control and Prevention, the National Health And Health Commission, the Ministry of Public Security and the Ministry of Civil Affairs.
population death registration data contains all the information in the death medical certificate, records the cause of death and the time of death, and can produce data sources of death rate per person.
8. Patient-Reported Outcomes (PATIENT-Report Outcome, PRO) is an indicator of patients' own measurement and evaluation of disease outcomes, including symptoms, physiology, psychology, medical service satisfaction, etc., and PRO is becoming more and more important in the development of drug evaluation system.
it records both paper and electronic, the latter called electronic patient reporting outcomes (ePRO), and the rise and application of ePRO makes it possible for PRO to interface with electronic medical records systems and form a complete data flow at the patient level.
. Individual health monitoring data from mobile devices Personal health monitoring data can capture individual physiological signs in real time from mobile devices (e.g. smartphones, wearable devices).
These data are often generated by the self-health management of the general population, the monitoring of patients with chronic diseases by medical institutions, the process of evaluating the health status of the insured population by health insurance companies, and is usually stored in wearables companies, medical institution databases, and commercial insurance company data systems.
because of the convenience and immediacy of wearable devices in collecting physiological and sign data, connecting with electronic health data can lead to a more complete RWD.
10. Other specific functional data (1) Public health surveillance data China has established a series of databases on public health surveillance, such as infectious disease surveillance, adverse immunization events (Adverse Events Immunization, AEFI) monitoring, etc., the recorded data can be used to analyze the incidence of infectious diseases, the general response of vaccines and the incidence of abnormal reactions.
(2) Patient follow-up data In real-world clinical diagnosis and treatment environment, in-hospital electronic medical record data often can not cover some important clinical indicators of patients, such as total survival, five-year survival rate, adverse reaction information, etc., need to supplement long-term follow-up data to form an applicable RWD.
Patient follow-up data mainly refers to the purpose of clinical research, hospital follow-up departments or third-party authorized service providers by letter, telephone, outpatient, SMS, network follow-up and other means to leave the hospital patients to carry out clinical endpoint, rehabilitation guidance, medication reminders, satisfaction surveys and other services, the service collected in the out-of-hospital data, usually stored in the hospital follow-up data system.
by connecting with the medical record data, multi-source clinical data can be combined to form a complete data covering the patient life cycle, which can be used to explore the mechanism of disease occurrence, development law, treatment methods, prognosis-related factors and other clinical research issues.
(3) Patient drug use data The drug use data of patient diagnosis and treatment process include patient information, pharmaceutical products, dosages and adverse reactions, etc., which are usually stored in hospital drug management information system, pharmaceutical e-commerce platform, pharmaceutical enterprise product traceability and drug safety information database, and drug use monitoring platform.
With the popularity of remote diagnosis and treatment and the management mode of Internet-plus chronic diseases, the number of patient out-of-hospital drug use data stored on prescription transit platforms or pharmaceutical e-commerce platforms has gradually increased, and the effective use or stitching of such data can be used as an RWD source for patient dimension diagnosis and treatment process records.
with the continuous development of medical information technology, new RWD types and sources will emerge, but their specific application depends on the clinical research problems to be solved and the applicability of RWE supported by this data.
References to the Drug Review Center of the State Drug Administration of China. Retrieved Aug 3, 2020, from ▽ attention to the Public No.