The "All of Us" research program is a research project supported by the National Institutes of Health. By recruiting over 1 million volunteers residing in the United States, the project builds a strong research resource to promote the exploration of biological, clinical, social, and environmental determinants of health and disease. This paper introduced the design plan of the "All of Us" research program systematically and provided information that can be used for the construction of a million natural population cohort of precision medicine in China.
Precision medicine is a personalized medical system based on patients' individual biological information, clinical symptoms and signs, forming a new clinical research model and medical practice path. The basic idea of traditional Chinese medicine and the concept of precision medicine share many similarities. The basket trial developed for precision medicine is also suitable for clinical trials and evaluation of the efficacy of traditional Chinese medicine syndrome differentiation and treatment systems. Basket trials are used to evaluate the efficacy of a drug in the treatment of multiple diseases or disease subtypes. It has the advantages of sharing a master protocol, unifying management of subsidiary studies, simplifying the test implementation process, unifying statistical analysis, saving resources, reducing budgets and accelerating the drug evaluation progress. This is similar to the concept of using the "same treatment for different diseases" found in traditional Chinese medicine. This paper introduced the concept and method of basket trials and explored their application and advantages in clinical research into traditional Chinese medicine. This study is expected to provide references for the methodological innovation of clinical research into traditional Chinese medicine.
Tuberculosis (TB) is one of the major public health concerns worldwide. Since the development of precision medicine, the filed regarding TB control and prevention has been brought into the era of precision medicine. Although great progress has been achieved in the accurate diagnosis, treatment and management of TB patients, we have to face several challenges. We should seize the opportunity, and develop and improve novel measures in TB prevention on the basis of precision medicine. The accurate diagnosis criteria, treatment regimen and management of TB patients should be carried out according to the standard of precision medicine. We aim to improve the treatment of TB patients and prevent the transmission of TB in the community, thereby contributing to the achievement of the End TB Strategy by 2035.
Retinitis pigmentosa (RP) is an inherited retinal disease characterized by degeneration of retinal pigment epithelial cells. Precision medicine is a new medical model that applies modern genetic technology, combining living environment, clinical data of patients, molecular imaging technology and bio-information technology to achieve accurate diagnosis and treatment, and establish personalized disease prevention and treatment model. At present, precise diagnosis of RP is mainly based on next-generation sequencing technology and preimplantation genetic diagnosis, while precise therapy is mainly reflected in gene therapy, stem cell transplantation and gene-stem cell therapy. Although the current research on precision medicine for RP has achieved remarkable results, there are still many problems in the application process that is needed close attention. For instance, the current gene therapy cannot completely treat dominant or advanced genetic diseases, the safety of gene editing technology has not been solved, the cells after stem cell transplantation cannot be effectively integrated with the host, gene sequencing has not been fully popularized, and the big data information platform is imperfect. It is believed that with the in-depth research of gene sequencing technology, regenerative medicine and the successful development of clinical trials, the precision medicine for RP will be gradually improved and is expected to be applied to improve the vision of patients with RP in the future.
This paper introduces the background and research design (including site of investigation, study population, baseline survey and follow-up monitoring), which belongs to the Precision Medicine Project of the National Key Research and Development Program of China.
Mixed reality technology is new digital holographic imaging technology that generates three-dimensional simulation images through computers and anchors the virtual images to the real world. Compared with traditional imaging diagnosis and treatment methods, mixed reality technology is more conducive to the advantages of precision medicine, helps to promote the development of medical clinical application, teaching and scientific research in the field of orthopedics, and will further promote the progress of clinical orthopedics toward standardization, digitization and precision. This article briefly introduces the mixed reality technology, reviews its application in the perioperative period, teaching and diagnosis and treatment standardization and dataization in the field of orthopedics, and discusses its technical advantages, aiming to provide a reference for the better use of mixed reality technology in orthopedics.
ObjectivesTo initially construct a scientific, reasonable and precision medicine technology value judgment framework suitable for China’s national conditions based on expert consultation method, so as to provide scientific value judgment system support for China's medical insurance decision-making.MethodsThe preliminary evaluation indicator system for precision medicine technology value was established by using literature analysis and expert consultation method, and the direct weighting method was used to determine the indicators weight.ResultsAfter two rounds of expert consultation, an indicator system suitable for the value judgment of precision medicine technology in China was constructed, including 5 primary indicators (health needs, health effects, economics, innovation and suitability) and 14 secondary indicators. Each indicator was weighted according to importance.ConclusionsA set of precision medicine value judgment indicator system suitable for China has been initially established, which lays a certain foundation for further measurement research of the indicator system and provides a scientific basis for medical insurance decision-making.
Abstract Precision medicine is an ideal medical paradigm which combines modern scientific methods with traditional medical methods to diagnose, treat and evaluate the physical function and nature of diseases more precisely, and to maximize health benefits and minimize the risk of individuals and society with the most effective, safest, and the most economical medical service. Evidence-based medicine is necessary to verify the precision of diagnosis and treatment. In this review, we clarified the conception of precision medicine and the relation between precision medicine and evidence-based medicine. Moreover, we reviewed the application of precision medicine in the field of cerebrovascular disease. We pointed out that such new technologies as genetics, bioinformatics, molecular imaging and management provided tools to realize the idea of precision medicine, and high-quality evidence-based studies provided a guarantee for the clinical practice of precision medicine. In summary, precision medicine is an individualized medical mode that based on the context of a patient's genetic information, living environment and clinical data, etc. to provide precise treatment strategies for the prevention and treatment of disease, but still the promotion of precision medicine should be based on clinical validation under the guidance of evidence-based medicine. Thus, long-term exploration and unremitting efforts are required to achieve the idea of precision medicine.
The 14th Five-Year Plan for National Health explicitly proposes elevating the comprehensive prevention and control strategy for chronic diseases to the national strategy, aiming to address the growing demand for long-term management and individualized treatment of chronic diseases. In this context, the adaptive treatment strategy (ATS), as an innovative treatment model, offers new ideas and methods for the management and treatment of chronic diseases through its flexible, personalized, and scientific characteristics. To construct ATS, the sequential multiple assignment randomized trial (SMART) has emerged as a research method for multi-stage randomized controlled trials. The SMART design has been widely used in international clinical research, but there is a lack of systematic reports and studies in China. This paper first introduces the basic principles of ATS and SMART design, and then focuses on two key elements of the SMART design: re-randomization and intermediate outcomes. Based on these two elements, four major types of SMART designs are summarized, including: (1) SMART designs in which the intermediate outcome corresponds to a single re-randomization scheme (the classical type), (2) SMART designs in which no intermediate outcome is embedded, (3) SMART designs in which the intermediate outcome corresponds to a different re-randomization scheme, and (4) SMART designs in which the intermediate outcome and the previous interventions jointly determine the re-randomization. These different types of SMART designs are appropriate for solving different types of scientific problems. Using specific examples, this paper also analyzes the conditions under which SMART designs are applicable in clinical trials and predicts that the mainstream analysis methods for SMART designs in the future will combine frequentist statistics and Bayesian statistics. It is expected that the introduction and analysis in this paper will provide valuable references for researchers and promote the widespread application and innovative development of SMART design in the field of chronic disease prevention, control, and treatment strategies in China.
Basing on development of medical model, new national diagnostic standard is interpreted according to three aspects: classification, diagnostic standard, and diagnostic contents. Tracheobronchial tuberculosis and tuberculous pleurisy are added into the classification. The value of molecular and pathological techniques for diagnosis of the pulmonary tuberculosis is emphasized. The status of drug-resistance is included in the diagnostic content. Two opinions are suggested: some practical methods such as diagnostic chemotherapy are indicated in some grassroots areas, while new molecular techniques for detection of DNA/RNA of mycobacteria and resistant mutation are encouraged in some suitable institutions.