Objective To estimate heart function among patients with diabetic foot ulcer,and to investigate the characteristics of heart failure(HF) before and after treatment of ulcer. Methods Items associated with diabetes and some physiological and biochemical indicators were observed in patients with diabetic foot ulcer(162 cases) and with high risk factors of ulcer(75 cases). Heart function was evaluated at patients′ admission, during ulcer related treatment, and prior to discharge. Left ventricular ejection fraction and other cardiac assessment were measured with ultrasonic scan.Results During hospitalization, 23.6%(56/237) patients underwent HF with normal left ventricular ejection fraction, and it was 27.2%(44/162) in patients with foot ulcers. The prevalence of HF was 8.9%(21/237) in all patients studied on admission, and that was 10.5%(17/162) in patients with foot ulcer, more than that without foot ulcer(P＜0.01). More patients with HF were found, being 14.8%(35/237) during 2-7 days after ulcer related treatment initiated, and peak was on the 4th day. There was statistical difference among different Wagner grades(P＜0.05) about the morbidity rate of HF. All patients with HF were improved and tolerant to ulcer related treatment. Conclusion The prevalence of HF with normal left ventricular ejection fraction was relatively high in patients with diabetic foot ulcer, especially after ulcer treatment.

Uyghur medicine has not yet had the clinical research guidelines consistent with Uyghur medicine theory for its new medicine. In this research, retrospective multi-center study on medical records of Uyghur medicine diagnosis and treatment program of stable angina was conducted. Data about demography, diagnostics, therapeutics, efficacy evaluation, and nursing were collated and analyzed. Uyghur medicine syndrome diagnosis indicators and their contribution to stable angina were identified, and Uyghur medicine syndrome differentiation criteria were established. Uyghur medicine established its primary and secondary disease syndrome and its symptoms quantization table entries for the syndrome elements of Uyghur medicine syndrome differentiation criteria. Then combined with symptoms of angina and ECG changes, nitroglycerin stop and decrement rate, evaluation criteria for the efficacy of disease symptom combination were established. On this basis, in accordance with the technical requirements of the national new medicine evaluation, the study developed clinical research guidelines for the treatment of stable angina with new Uyghur medicine.

Retrospective multi-center study on medical records of Uyghur medicine diagnosis and treatment program of eczema was done. Demography, diagnostics, therapeutics, efficacy evaluation and nursing data and other information were collated and analyzed. With analysis and summary of the primary and the secondary symptoms, eczema was divided into four types:blood corruption type (Ofunetlengen Kan Tiplik), blue colored yellow bile type (Zenggereng Sapra Tiplik), abnormal black bile type (Hayri Tabii Savda Hilitlik), and salty phlegm type (Shor Belgem Hilitlik). Uyghur Medicine syndrome differentiation and efficacy evaluation criteria were established. Skin itching, lesion shape, and lesion area integral of patients were scored before and after the treatment, respectively. According to the improvement in symptoms of Uyghur medicine syndrome and life quality of patients, and the internal environment change, evaluation criteria for the efficacy of disease symptom combination were established. On this basis, in accordance with the technical requirements of the national new medicine assessment technology, the study developed clinical research guidelines for the treatment of eczema with new Uyghur medicine.

The multi-central clinical records retrospective survey for psoriasis vulgaris was carried out by collecting related information such as demographic, diagnostics, therapeutics, efficacy evaluation, nursing data, and so on. The Uygur medical differentiation classification standard about psoriasis vulgaris was established and it was divided into four types:abnormal Khan Hilit type, abnormal Sapra Hilit type, abnormal saltness Balgham Hilit type, and abnormal Sawda Hilit type, according to main symptom and secondary symptom feature. The disease efficacy evaluation standard was established based on score of surface area and severity of skin injury combining with the changes of main symptom and secondary symptoms. On the basis, guidelines for clinical research of new drugs of Uygur medicine used in the treatment of psoriasis vulgaris were formulated in accordance with the technical requirements and procedure of national center for drug evaluation.

The liver injury caused by drug and / or its metabolites is one of the most common reasons for drugs to be withdrawn or disapproved.Premarketing clinical evaluation of drug-induced liver injury (DILI) is extremely important to drug evaluation.Signals of DILI and Hyman's Law (Hy's Law),clinical evaluation and lessons of DILI were discussed to help developing new drugs.

Lung cancer is the highest mortality rate of malignancies in the world.Among them,non-small cell lung cancer (NSCLC) accounts for 85％.Epidermal growth factor receptor (EGFR) gene is one of the most common driving genes in NSCLC.The EGFR tyrosine kinase inhibitors (EGFR-TKIs) bring a breakthrough in the treatment for patients with EGFR gene-sensitive mutations.However,the drug resistance problem of EGFR-TKIs has been increasingly highlighted.So a drug for the patients accompanied by EGFR T790M positive mutation and along with progression in or after treatment with EGFR-TKI NSCLC is clinically urgent needed.Rociletinib is designed to address this unmet clinical need.While considering the non-superior effectiveness to the similar drugs in the market and the high risk of safety (hyperglycemia,QT prolongation and sudden death) of Rociletinib,the dosage was not accepted by the Food and Drug Administration (FDA).And Rociletinib did not make it to the market eventually.This paper discussed lessons learned from this case under review perspective for reference and inspiration.

TThe USA Food and Drug Administration (FDA) has an over 100-year history and is the most authority drug administration.During its past records,the most important thing for FDA is facing law enforcement challenges.However,FDA insists on improving legislation and finding the perfect mode of regulation.This paper introduced the history evolution,regulatory course,present office structure of FDA,Center for Drug Evaluation and Research (CDER),and Center for Biologics Evaluation and Research (CBER).The frustration and experience for FDA is well discussed.The legislation system is interpreted through historical events.To learn the developmental and regulatory history of USA food and drug administration is important to our drug administration for practicing the mission of protecting and promoting public health.

In recent years， adaptive design has gradually emerged in clinical trials， gaining widespread application and expansion. Compared with traditional randomized controlled trials， appropriate adaptive design can save time and resources to some extent， improve the validity of the trial results and strength of the evidence， align better with ethical requirements， and facilitate subsequent drug market research. However， due to the greater flexibility of adaptive design， controlling type Ⅰ error rates and truly enhancing research efficiency are challenging aspects of its application. Therefore， the normative application and optimization of adaptive design in research deserve early focus， including adhering to good adaptive design principles， conducting rigorous pre-design planning， scientifically applying various statistical methods such as Bayesian dynamic models and simulation methods， and utilizing monitoring tools like monitoring committees to ensure the scientific integrity of the research process. Moreover， the flexibility of adaptive design aligns well with the practical realities of traditional Chinese medicine （TCM） clinical practice. The main characteristics of TCM， such as the holistic concept and treatment based on syndrome differentiation， determine that TCM provides a dynamic and personalized treatment plan. In contrast， the traditional fixed development approach of western medicine limits the application of "human experience" in TCM. To address this bottleneck in TCM research and development， the innovative use of adaptive design， a modern scientific theory and methodology with multiplicity and variability， offers a feasible new approach for TCM clinical research and the innovation of Chinese herbal medicine. By learning from successful cases such as the first Food and Drug Administration （FDA）-approved oral botanical drug， Crofelemer， researchers can explore optimal solutions for adaptive design in clinical research protocols and its role in the "three-combination" evaluation system for Chinese herbal medicines， further refine trial design， clarify key trial points， and develop innovative research and development applications that adapt to the clinical positioning of TCM and highlight the characteristics and advantages of TCM， paving the way for the clinical efficacy， pharmacological mechanism exploration， and post-market efficacy evaluation of Chinese herbal compounds.

The advent of digital times promotes the evolution of clinical research from traditional mode to digital mode. Digital technologies， which are introduced to clinical research of traditional Chinese medicine （TCM）， can optimize the research design， improve research quality， and save research funds and time. The digital and remote control of clinical research recruitment and screening， disease diagnosis and treatment， informed consent， indicator measurement， and other processes can be realized by computers， networks， sensors， and other technologies. Artificial intelligence （AI） algorithms， wearable monitoring devices， data management tools， blockchain， and virtual clinical trials （VCTs） are key innovation technologies and research design methods. On this basis， this study summarized relevant literature on key digital technologies and research methods such as AI algorithms， wearable monitoring devices， data management tools， blockchain， and VCT， and the following discoveries were obtained： The future development of clinical research of TCM requires to attach importance to the changes in clinical research brought by digital technologies and to promote the utilization of digital technologies in clinical research of TCM. Digital technologies realize the medical ethical ideas of ''putting people first''， promote the decentralization of clinical research， simplify the participation process of participants， reduce the time and cost of clinical research， improve the efficiency of clinical research of TCM， and enhance the objectivity， authenticity， and stability of clinical research of TCM. Deepening the application of digital technologies in clinical research and realizing the interaction and fusion of various digital technologies are inevitable trends of future development of clinical research of TCM. Under the background of digitization， the digital innovation of clinical research of TCM can accelerate the development of clinical research of TCM and promote the internationalization of TCM.

Traditional Chinese medicine(TCM)regulatory science,as an emerging interdisciplinary science,evaluates the safety,effectiveness,quality,and risk-benefit profile of regulated Chinese medicinal products,including Chinese medicinal materials,Chinese medicinal slices,and Chinese patent medicines.It highlights the development of new tools,standards,and methods that align with the unique characteristics of TCM.TCM regulatory science plays a crucial role in establishing a TCM scientific regulatory system that suits the features of TCM,accelerating the transformation of emerging TCM technologies and facilitating innovation in the inheritance and development of TCM.Sichuan,known as the"hometown of TCM therapies and the treasure trove of TCM",has built the first national modernized TCM technology industrial base and one of the first national comprehensive TCM reform demonstration zones.It plays a demonstrative and leading role in the high-quality development of the TCM industry in China.Based on the latest progress in new tools,standards,and methods of TCM regulatory science,this article overviewed its significant role and prospects in enhancing the efficiency of TCM regulation,accelerating the transformation and application of new TCM technologies and products,and promoting the high-quality development of the TCM industry in Sichuan.It is of great significance for ensuring and improving the regulatory capabilities of TCM and driving the healthy development of the TCM industry.