The pre-market approval and clinical application of innovative medical devices should be based on high-quality evidence, proving their reliability, safety and effectiveness. In 2016, the IDEAL (Idea, Development, Exploration, Assessment and Long-term follow-up) collaboration modified the original IDEAL framework and recommendation to the IDEAL-D methodological framework for the entire life cycle evaluation of innovative medical devices. The framework included five stages, namely the preclinical development stage, idea stage, exploration stage, assessment stage and long-term follow-up stage. This paper aims to interpret the study purpose, content and design at each step of the IDEAL-D framework based on IDEAL framework and recommendation (2019) to provide practical methodological guidance for the design and conduct of clinical research on innovative medical devices.
At the end of 2022, the National Medical Products Administration (NMPA), in conjunction with the National Cancer Center, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College raised for the first time the important issue of clinical research globally: whether the source of the death time of clinical trials based on the simple follow-up records is credible, and proposed a consensus document on the source of the death time of clinical trials. The results were published in The Lancet Regional Health-Western Pacific, which attracted wide attention and recognition from the international industry. This is the first time that the China consensus on quality standards for clinical research has been ahead of the U.S. Food and Drug Administration and other international colleagues. The NMPA has been leading China in promoting the scientific development of clinical research, so as to constantly establish and improve the scientific regulatory system and ecological system, and promote China's full integration into the global pharmaceutical research and development system. China clinical research institutions and the whole industry are also gradually from standardized development to scientific development, high-quality development process. In this study, we summarized the scientific and subject-oriented development of China clinical research industry in recent years, and continuously strengthened the international competitiveness of China pharmaceutical industry. It is suggested that scientific thinking model should be used to deal with the normative problems in clinical research and promote the development of medical model to scientific model.
New interventions are rapidly progressing into clinical practice through the preclinical study stage. The animal experiments should be comprehensive and critically evaluated for their pivotal role in this process. To integrate the evidence of animal studies by systematic review throws light on intervention outcomes and could decrease risk of participants in human trials. The methodological weakness of animal studies is easy to highlight but robust methods to synthesize evidence is essential. Here, we discuss some problems in systematic review of animal experiments and whether animal models of diverse species contribute to bias of meta-analysis conclusions.
With the continuous development of China's aging society and the prevalence of unhealthy lifestyles, the incidence of cardiovascular disease in China has been increasing in recent years. Among them, atrial fibrillation (AF) is the most common arrhythmia disease. In recent years, pulsed field ablation (PFA) has been continuously applied to AF treatment as a novel treatment. This paper first introduces the principle of PFA applied to AF treatment, and introduces the research progress of PFA in different directions, such as the comparison of different ablation methods, the study of physical parameters, the study of ablation area, the study of tissue specificity and clinical research. Then, the clinical prior research of PFA is discussed, including the use of simulation software to obtain the simulation effect of different parameters, the evaluation of ablation effect during animal research, and finally the current AF treatment. Various prior studies and clinical studies are summarized, and suggestions are made for the shortcomings found in the study of AF treatment and the future research direction is prospected.
Objective To understand the current status of the preferences and opinions on the investigator-initiated trails (IIT) of the neurosurgeons participating in INTERACT3 in China, as well as the design preference for IIT projects, and to provide a basis for the design and organization of multi-center clinical studies in the future. Methods Neurosurgeons with different seniority and professional titles from 89 domestic research institutions participating in the INTERACT3 project were collected from September to October 2023. The questionnaires were collected by questionnaire star. Results A total of 56 valid questionnaires were collected from 29 units. Among the 56 respondents, 52 neurosurgeons (92.86%) were from teaching hospitals and 45 (80.36%) were from grade A tertiary hospitals. 30 neurosurgeons (53.57%) had experience in conducting various clinical studies, and 55 neurosurgeons (98.21%) had experience in participating in various clinical studies. The main purposes of presiding over or participating in clinical research focused on “accumulating relevant experience and preparing for future projects” and “standardizing clinical diagnosis and treatment”, which were 89.29% and 83.93%. Respectively, regarding the way the case report form completing, respondents preferred to use electronic data collection systems (83.93%). Conclusions The purpose of the neurosurgeons interviewed to host or participate in clinical research is mainly to assist clinical and scientific research. Economic reasons have little impact on whether to participate in clinical research. The rationality and ease of operation of the trail design are the keys to attracting respondents to participate in clinical researches, and the level of remuneration has little impact on the decision-making of the respondents. The safety of clinical studies and the difficulty of enrolling subjects are the key factors that hinder respondents’ participation in clinical studies.
Neurofibromatosis type 1 (NF1) is an autosomal dominant genetic disease caused by mutations in the NF1 gene. The disease is characterized by neurofibromatosis, which simultaneously affects multiple systems such as nerves, skin, and bone, and has complex clinical manifestations. Since the National Institutes of Health (NIH) established diagnostic criteria in 1988, the diagnosis and treatment of NF1 have progressed significantly. However, due to the complexity of the disease and the lack of effective treatments, the diagnosis and treatment of NF1 still face many challenges. Strengthening multidisciplinary collaboration, improving and popularizing disease diagnosis and treatment strategies, and developing more effective drugs and treatment methods are the keys to further improve the treatment level of NF1 diseases.
ObjectiveTo evaluate the safety of shearing fracture ligation combining procedure for prolapse and hemorrhoids （PPH） in treatment for mixed hemorrhoids via a multicenter clinical study. MethodsTwo hundred and fortysix patients with mixed hemorroids were included from four a level of firstclass hospitals, which were averagely divided into shearing fracture ligation combining PPH group, PPH group, and shearing fracture ligation group according to the order of admission. The occurrence status of rectovaginal fistula, urethrorectal fistula, postoperative bleeding, acute urinary retention, anorectal stenosis, and anal incontinence were observed. And the anal function was evaluated by the anorectal pressure measurement. ResultsNo rectovaginal fistula or urethrorectal fistula happened among three groups. No anorectal stenosis happened in the shearing fracture ligation combining PPH group or the PPH group. The score of anorectal stenosis and anal incontinence in these two groups were lower than those in the shearing fracture ligation group (Plt;0.05). The rate of postoperative bleeding in the shearing fracture ligation combining PPH group was lower than that in the shearing fracture ligation group (Plt;0.05). There were acute urinary retentions happened among three groups, but without significant differences among them (Pgt;0.05). The anal canal resting pressure after operation was lower than that before operation among three groups (Plt;0.01), which in the shearing fracture ligation combining PPH group was lower than that in the shearing fracture ligation group after operation (Plt;0.05). There were no significant differences of the rectum feeling capacity or maximum rectum capacity between the shearing fracture ligation combining PPH group and PPH group before and after operation (Pgt;0.05), but compared with the level before operation in the shearing fracture ligation group, the rectum feeling capacity obviously decreased after operation (Plt;0.05), the maximum rectum capacity obviously increased (Plt;0.05). There were no significant differences of the maxinum anal canal systolic blood pressure between before and after operation in three groups and among three groups (Pgt;0.05). ConclusionsThe operation of shearing fracture ligation combined with PPH can protect the tissue of rectal cushion, remain the normal anatomy structure of anal canal. It has better clinical effect and is much safer than other methods.
ObjectiveTo review the clinical research progress of mesenchymal stem cells (MSCs) in the treatment of chronic wounds.MethodsThe literature related to the chronic wound repair with MSCs at home and abroad in recent years was extensively reviewed, and the possible mechanism of MSCs in the treatment of chronic wounds, as well as its application and existing problems were summarized.ResultsMSCs can participate in all aspects of chronic wound healing to promote wound healing, and has shown broad application prospects in clinical trials. MSCs commonly used in clinical research include bone marrow-derived MSCs, adipose-derived tissue MSCs, and umbilical cord-derived MSCs.ConclusionMSCs treatment is a promising strategy for the chronic wounds, but there are still many problems in its widespread clinical application that require further research.
Rare diseases are mostly genetic disorders that often manifest in childhood, characterized by severe conditions, difficulties in diagnosis and treatment, and poor homogeneity in clinical management. Clinical research on rare diseases contributes to enhancing the diagnosis and treatment capabilities for rare diseases in China and promotes the development of rare disease medicine. Clinical research on rare diseases in China started relatively late, and there is currently no mature and comprehensive system for clinical research on rare diseases. This article analyzes the current state of clinical research on rare diseases in China, identifies existing problems and research difficulties, and proposes ideas and key measures for the construction of China’s clinical research system on rare diseases, aiming to provide opinions and suggestions for the construction of China’s clinical research system on rare diseases.
Master protocol with adaptive design is a new complex innovative trial design that combines an adaptive treatment strategy and master protocol. It is more flexible and adjustable. In the complex clinical trial environment, the dynamics emphasized in this design are consistent with the idea of traditional Chinese medicine (TCM) syndrome differentiation and treatment. In this study, we summarized its concept, characteristics and advantages, and we also discussed its application in TCM clinical research. We hope this paper can provide more thinking and suggestions for TCM clinical trials.