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.
The umbrella trial has received increasing attention in the design of clinical trials for oncology drugs in recent years. This trial design categorizes a single disease into multiple sub-types based on predictive biomarkers or other predictive factors, and simultaneously evaluates the efficacy of multiple targeted therapies. When compared with the traditional drug development model of phase Ⅰ, phaseⅡ, and phase Ⅲ randomized controlled trials, umbrella trials are a more scientifically rigorous trial design that can speed up drug evaluation to address the conflict between numerous untested drugs and diseases with a lack of effective treatment options. This article will focus on the concept, main characteristics, eligibility criteria, design and statistical considerations, ethical considerations, and future directions of umbrella trials, with the aim of providing methodological guidance for the design of clinical trials for oncology drugs.
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.
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.
Precision medicine is a novel medical modality based on genome sequencing, bioinformatics and big data science. The studies regarding tuberculosis always concentrated on the bacteria and host in the setting of precision medicine. This review mainly introduces the application of precision medicine in the diagnosis and treatment of tuberculosis. The limits of the Chinese studies with respect to precision medicine in tuberculosis are also discussed. Moreover, the article predicates its future development.
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.
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.
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.
In order to promote the responsible development of precision medicine in China, the current situation of precision medicine in three major fields (clinical, research and commercial) was briefly introduced, and key ethical issues or disputes in each field (including informed consent, return of incidental findings, and allocation of medical resources in the clinical field; informed consent, return of research results, and data use and sharing in the research field; genetic counseling, clinical utility of genetic testing, and use of data in the field of direct-to-consumer genetic testing) were discussed. It is necessary to actively meet these ethical challenges for the development of precision medicine in China.
ObjectiveTo summarize current patient-derived organoids as preclinical cancer models, and its potential clinical application prospects.
MethodsCurrent patient-derived organoids as preclinical cancer models were reviewed according to the results searched from PubMed database. In addition, how cancer-derived human tumor organoids of pancreatic cancer could facilitate the precision cancer medicine were discussed.
ResultsThe cancer-derived human tumor organoids show great promise as a tool for precision medicine of pancreatic cancer, with potential applications for oncogene modeling, gene discovery and chemosensitivity studies.
ConclusionThe cancer-derived human tumor organoids can be used as a tool for precision medicine of pancreatic cancer.
