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

On August 3rd, the Drug Review Center (CDE) of the State Drug Administration of China (CDE) issued a notice on the public soliciting of opinions on the Guidelines for Real World Data used to produce real-world evidence (draft for comments).
real-world data is the basis for producing real-world evidence, and high-quality and 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 include structured and unstructured digital or non-digital patient records, such as patient demographic characteristics, clinical characteristics, diagnosis, treatment, laboratory examination, safety and clinical outcomes, which are often distributed among different information systems such as electronic medical records/electronic health records (EMR/EHR), laboratory information management system (LIS), medical imaging archive and communication system (PACS), radiology information management system (RIS).
some medical institutions set up hospital-level scientific research data platform on the basis of data integration platform or clinical data center (CDR), integrate patient outpatient, inpatient, follow-up and other information to form data directly used in clinical research.
some regional medical databases, using a relatively centralized physical environment for the storage and processing of clinical data across medical institutions, with large storage, many types and so on, can also be used as a potential source of RWD.
hospital information system data are based on the records of clinical diagnosis and treatment practice, 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 data on basic information about patients, the utilization of medical services, prescriptions, settlement, medical claims and planned health care and other structured fields.
other type is the commercial health insurance database, established by insurance institutions, the data to the insurance company claims payment and insurance duration as a classification index, 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.
the population characteristics defined by the study mainly include product registration, health service registration and disease registration, and the registration research in China is mainly disease registration and product registration research.
, medical institutions and enterprises support the product registration research, the object of observation is the use of a pharmaceutical product cases, focusing on the effects of their different adaptive disorders or monitoring adverse reactions. The advantage of the
registration research database is that it takes specific patients as the research population, through the integration of clinical diagnosis and treatment, medical insurance payment and other data sources, data collection is more standardized, generally including patient self-reporting data and long-term follow-up data, observational outcome indicators are usually rich, with higher 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 drug safety monitoring data Active drug safety monitoring data are mainly used to carry out drug safety research and drug epidemiology research, through national or regional drug safety monitoring networks, from medical institutions, pharmaceutical companies, medical literature, online media, patient reporting outcomes and other channels, data collection.
, the safety monitoring databases of their own medicines, established by medical institutions and enterprises themselves, may also be part of such data sources.
. Natural Population Queue Data Natural Population Queue Data refers to data obtained from long-term forward-looking dynamic tracking observations of the general population or people with major diseases.
the natural population queue data has the characteristics of unified standard, information sharing, long time span and large sample size, such RWD can help build a common disease risk model, can support the precise target population positioning of drug research and development.
6. Histological data Histological data as an important support for precision medicine, including genomics, exogenetics, transcription, proteomics and metabolic groups and other data, these data from a systematic biological point of view of the patient in genetics, physiology, biology and other aspects of the characteristics.
usually histological data need to be combined with clinical data to become applicable RWDs.
. Death Registration Data Population Death Registration is a continuous and complete collection and recording of death information of its nationals in a country.
china currently has four systems for collecting information on deaths, belonging to the National Center for Disease Control and Prevention, the National Health Commission, the Ministry of Public Security and the Ministry of Civil Affairs.
data on deaths in the population contain all the information in the medical certificate of death, record detailed causes of death and the time of death, and produce data sources for the death rate of the population by cause of death.
8. Patient-Reported Outcomes (Patient-Reported Outcomes, PRO) is an indicator from the patient's own measurement and evaluation of disease outcomes, including symptoms, physiology, psychology, satisfaction with medical services, etc., pro is becoming more and more important in the development of drug evaluation system.
the rise and application of ePRO, which records both paper and electronic, known as ePRO, make it possible for PRO to interface with electronic medical records systems and form a complete flow of data at the patient level.
. Individual health monitoring data from mobile devices Personal health monitoring data can capture individual physiological signs in real time via mobile devices (e.g. smartphones, wearables).
These data are often generated from the self-health management of the general population, the monitoring of chronically ill patients by medical institutions, and the assessment of the health status of the insured population by health insurance companies, and are usually stored in wearable enterprises, medical institution databases, and data systems of commercial insurance companies.
because wearables have the advantages of convenience and immediability in collecting physiological and sign data, connecting with electronic health data can lead to a more complete RWD.
10. Other functionally specific data (1) Public health surveillance data We have established a series of databases on public health surveillance, such as infectious disease surveillance, adverse immunization events (Adverse Events Following Immunization, AEFI) monitoring, etc., and the data recorded 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 consultation 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, in order 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 ways to leave the hospital patients to carry out clinical endpoint, rehabilitation guidance, drug reminder, satisfaction survey and other services, the service collected in the hospital follow-up data system.
Through the connection with medical record data, multi-source clinical data fusion can eventually form a complete data covering the life cycle of patients, to explore the mechanism of disease occurrence, development laws, treatment methods, prognosis-related factors and other clinical research issues.
(3) Patient drug use data Drug use data include patient information, drug category, dosage and adverse reactions, and are usually stored in hospital drug management information systems, pharmaceutical e-commerce platforms, pharmaceutical enterprise product traceability and drug safety information databases, as well as drug use monitoring platforms.
With the popularization of tele-diagnosis and Internet-slow disease management model, the number of patients' out-of-hospital drug use data stored on prescription transfer platform or pharmaceutical e-commerce platform is increasing gradually, and the effective use or stitching of such data can be used as a RWD source for patient dimension diagnosis and treatment process recording.
with the development of medical information technology, new RWD types and sources will emerge, but their specific application depends on the clinical research issues to be addressed and the applicability of RWE supported by this data.
Reference Center of the State Drug Administration of China. Retrieved Aug 3,2020, from.