Challenges and Suggestions of Ethical Review on Clinical Research Involving Brain-Computer Interfaces

Brain-computer interface(BCI)technology is rapidly advancing in medical research and application.As an emerging biomedical engineering technology,it has garnered significant attention in the clinical research of brain disease diagnosis and treatment,neurological rehabilitation,and mental health.However,BCI also raises several challenges and ethical concerns in clinical research.In this article,the authors investigate and discuss three aspects of BCI in medicine and healthcare:the state of international ethical governance,multidimensional ethical challenges pertaining to BCI in clinical research,and suggestive concerns for ethical review.Despite the great potential of frontier BCI research and development in the field of medical care,the ethical challenges induced by itself and the complexities of clinical research and brain function have put forward new special fields for ethics in BCI.To ensure"responsible innovation"in BCI research in healthcare and medicine,the creation of an ethical global governance framework and system,along with special guidelines for cutting-edge BCI research in medicine,is suggested.

Enhancing competency of clinical research nurses:A comprehensive training and evaluation framework

The Sun et al's training program for clinical research nurses(CRNs)in the World Journal of Clinical Cases is a comprehensive and scientific approach.It includes structured frameworks for CRN training,aiming to improve CRN competency.This program emphasizes practical abilities,updates training content,and improves evaluation methods.The cultivation of CRN talents focuses on enhancing the training system,establishing a multifaceted evaluation framework,and continuously refining the training programs.Regular feedback and evalua-tion are essential to improve CRNs'competency in practical settings.

Near-Infrared Fluorescence Imaging Contrast Agents for Clinical Research: Limitations and Alternatives

Introduction: Near-infrared fluorescence imaging is a technique that will establish itself in the short term at the international level because it is recognized for its potential to improve the performance of surgical interventions, its moderate investment and operating costs and its portability. Although the technology is now mature, there is currently the problem of the availability of contrast agents to be injected IV. The aim of this methodology article is to propose an alternative solution to the need for contrast agents for clinical research, particularly in oncology. Methodology: They consist of coupling a fluorescent marker in the form of an NHS derivative, such as IR DYE manufactured in compliance with GMP, with therapeutic monoclonal antibodies having marketing authorization for molecular imaging. For a given antibody, the marking procedure must be the subject of a validation file on the final preparation filtered on a sterilizing membrane at 0.22 μm. Once the procedure has been validated, it would be unnecessary to repeat the tests before each clinical research examination. A check of the marking by thin-layer chromatography (TLC) and place it in a sample bank at +4˚C for 1 month of each injected formulation would be sufficient for additional tests if necessary. Conclusion: Molecular near-infrared fluorescence imaging is experiencing development, the process of which could be accelerated by greater availability of clinical contrast agents. Alternative solutions are therefore necessary to promote clinical research in this area. These methods must be shared to make it easier for researchers.

Demand and Analysis of Clinical Research Curriculum in Medical Universities

Objective:To investigate the needs of medical students regarding clinical research curricula to provide scientifically sound offerings and cultivate their clinical research thinking.Methods:From June to October 2022,medical students at medical universities in Shaanxi Province were surveyed using online questionnaires.The survey covered their demographic information,awareness of their major,understanding of clinical research,and preferences for curriculum content.Results:A total of 341 valid questionnaires were analyzed.Medical students demonstrated a strong awareness of their majors but a relatively low awareness of clinical research.There was significant demand for clinical research courses,with preferences for professionally oriented(81.8%),market-oriented(100%),theoretically and practically integrated teaching(78.6%),and application-focused(73.0%)courses.Conclusion:Medical colleges and universities should align clinical research curricula with the actual needs of medical students and clinical practice.Reforms in curriculum design and teaching methods are essential to better prepare students for careers in public health.

Guidelines on clinical research evaluation of artificial intelligence in ophthalmology(2023)

With the upsurge of artificial intelligence(AI)technology in the medical field,its application in ophthalmology has become a cutting-edge research field.Notably,machine learning techniques have shown remarkable achievements in diagnosing,intervening,and predicting ophthalmic diseases.To meet the requirements of clinical research and fit the actual progress of clinical diagnosis and treatment of ophthalmic AI,the Ophthalmic Imaging and Intelligent Medicine Branch and the Intelligent Medicine Committee of Chinese Medicine Education Association organized experts to integrate recent evaluation reports of clinical AI research at home and abroad and formed a guideline on clinical research evaluation of AI in ophthalmology after several rounds of discussion and modification.The main content includes the background and method of developing this guideline,an introduction to international guidelines on the clinical research evaluation of AI,and the evaluation methods of clinical ophthalmic AI models.This guideline introduces general evaluation methods of clinical ophthalmic AI research,evaluation methods of clinical ophthalmic AI models,and commonly-used indices and formulae for clinical ophthalmic AI model evaluation in detail,and amply elaborates the evaluation methods of clinical ophthalmic AI trials.This guideline aims to provide guidance and norms for clinical researchers of ophthalmic AI,promote the development of regularization and standardization,and further improve the overall level of clinical ophthalmic AI research evaluations.

Clinical research progress of traumatic brain injury related markers

Traumatic brain injury is a brain injury caused by biomechanics effects on brain tissue,In addition to primary brain injury,secondary brain injury caused by local brain injury,edema and high intracranial pressure on surrounding brain tissue further aggravates the disease.The improvement of modern medical equipment and medical technology can provide early intervention treatment for patients.However,due to the particularity of the disease and the complexity of pathological and physiological reactions,irreversible damage often occurs in the central nervous system,with high disability rate and mortality.In recent years,it has been found that the related biological markers in the process of TBI are related to brain tissue injury and neurological function,and have important clinical application value in judging the severity of brain injury and prognosis evaluation,which has been widely studied.This paper intends to summarize the clinical research progress of TBI-related prognostic markers.

CLINICAL RESEARCH OF IMPACTS ON PLASMA ENDOTHELIN AND INTELLIGENCE IN MULTI-INFARCT DEMATIA TREATED WITH CLUSTER PRICKING ON HEAD POINTS

Objective To probe into the impacts on the therapeutic effects and endothelin （ET） in multi-infarct dementia （MID） treated with cluster pricking on head points.Methods 60 cases of MID were randomized into acupuncture group and western medicine group,treated with cluster pricking on head points and huperzien A tablet respectively.Plasma ET lever,HDS,ADL and CNFDS （clinical neurological functional defect scoring） were determined before treatment,and the statistical analysis showed that there were no significant difference （P〉0.05）.Results In 8-week treatment,ET level in both groups were decreased,but it was decreased much more obviously in acupuncture group,indicating significant difference in the statistical comparison （P〈0.05）.The scores of HDS and ADL were all up in acupuncture and western medicine groups,but the significant statistical difference was obtained in the comparison between acupuncture group and western medicine group （P〈0.05）.In acupuncture group,the result of CNFDS was much down comparing with that before the treatment,indicating significant difference （P〈0.05）;but in western medicine group,there was no significant difference in CNFDS before and after treatment （P〉0.05）,suggesting that acupuncture reduces CNFDS of MID patient,neither for western medicine.Conclusion Cluster pricking on head points improves the intelligence of MID patient,reduces ET level and grades up HDS and ADL,moreover,it reduces CNFDS of MID patients and releases the symptoms.

Acupuncture-a national heritage of China to the world:international clinical research advances from the past decade

Acupuncture originated in China and is an important component of traditional Chinese medicine.The elucidation of its anesthetic mechanisms,the medical needs of Western societies,as well as the proven therapeutic effects of this technique have made it the most widely used medical practice in the world.The concept of evidence-based medicine has been introduced in acupuncture research for technical improvement and the production of high-quality clinical evidence.Upon reviewing the acupuncture clinical research over the past 10years,we found the gradually increasing range of diseases that it benefits,from pain management to neoplasms and genitourinary,digestive,and mental disorders.Acupuncture is included in a number of international guidelines for clinical practice.However,high-quality clinical evidence to support the efficacy and effectiveness of acupuncture is lacking as a result of multiple exceptional clinical trials conducted by Western researchers that have yielded antagonistic results.Future clinical research should focus on exploring objective evaluation methods for studying the therapeutic effects of acupuncture.

Progress in clinical research on the integration of Chinese and Western medicines for treating primary liver cancer

Primary liver cancer(PLC) is one of the most common malignant tumors in China. PLC is characterized by insidious onset, rapid progress, poor quality of life, and short survival time. Notably, current treatment strategies remain unsatisfactory. Traditional Chinese medicines(TCM) have been used to treat a variety of diseases, including liver diseases, for more than 2000 years. In this study, we performed a review of the use frequency and clinical efficacy of TCM in treating PLC. Relevant literature from January 1, 2009, to January 1, 2021 was retrieved from network databases of China National Knowledge Infrastructure(CNKI), Chongqing VIP, Wanfang, PubMed, and SinoMed. The most frequently used TCM and their efficacy in PLC treatment were summarized. Based on the inclusion and exclusion criteria, 33 articles were selected. Overall, the efficacy of the combination of TCM and Western medicines in the treatment of PLC was higher than that in the control groups(i.e. treatment with Western medicines alone)(65.11% vs.44.31%, P <.05). Among the 33 selected articles, 11 were investigated for TCM preparation(marketed drugs) and 22 for TCM formulas. In total, 102 types of TCM(single herbs) were used to treat PLC. The top five most frequently used TCM were Poria(14.71%), Astragali radix(13.73%), Atractylodis Macrocephalae Rhizoma(12.75%), Bupleuri radix(12.75%), and Glycyrrhizae radix et Rhizoma(11.76%). Of the 102 types of TCM, tonics were the most frequently used categories, followed by heat-clearing medicines, blood-invigorating medicines, and stasis-resolving medicines. Of 207 papers, 174(84.06%) could not be subjected to statistical analysis due to research quality. Further high-quality research on herb sources, formula components and dosage, toxicology, and ethics of TCM is necessary. In conclusion, TCM play a promising role in the treatment and management of PLC, although further investigations are warranted.

Clinical Research progress of traditional Chinese medicine in treating esophageal cancer

Esophageal cancer is one of the most common malignant tumors in the world. In recent years, the incidence and mortality of esophageal cancer have increased year by year, which has seriously threatened human health. Surgery, chemotherapy and radiotherapy, as the primary treatments of Western medicine, have achieved specific results in the clinic, but each has its limitations, this is mainly related to their side effects. The diversified treatment methods of traditional Chinese medicine have visible clinical effects, especially in terms of reducing toxicity and increasing efficiency. This present review reviews the research progress of esophageal cancer in terms of traditional Chinese medicine treatment, including the application of Chinese medicine extract, Chinese herbal compound, Chinese patent medicine and TCM external treatment in clinical practice, may provide valuable information for the adjuvant treatment of esophageal cancer with traditional Chinese medicine.

Clinical research progress of oral administration of traditional Chinese medicine in the treatment of dry eyes

Dry eye is a common and frequently occurring ophthalmology disease with complex etiology and easy recurrence.Oral administration of traditional Chinese medicine has the characteristicsof high curative effect and little toxic and side effect in the treatment of dry eye.This paper collates the domestic reported clinical studies on the oral administration of traditional Chinese medicine in the treatment of dry eye,which are discussed from four aspects:special prescription for specific disease,addition and subtraction of main prescription,treatment based on syndrome differentiation and proprietary Chinese medicine.The curative effect and advantages of traditional Chinese medicine in the treatment of dry eye are demonstrated,providing a reference for the treatment of dry eye in the future.

Russian clinical research policy does not guarantee results availability

AIM： To investigate results availability from clinical studies enrolling Russian subjects and Russian clinical research policy.METHODS： We analyzed Russian legislation and ethi-cal regulations about drug and devices approval, clini-cal research registration and the results availability. In August 2012, we searched International Clinical Trials Registry Platform and clinicaltrials.gov to fnd all regis-tered studies that had an investigational site in the ter-ritory of the Russian Federation. To fnd publication sta-tus, we searched the PubMed and Scirus bibliographical databases with trial registration number to fnd journal publications of the registered studies.RESULTS： We identifed 2062 registered research pro-tocols comprising 2017 international and 45 protocols sponsored by the Russian funding agencies. The num-ber of the studies enrolling Russian subjects increased dramatically from three studies in 2002 to 252 studies in 2012. Most studies （92%） were funded exclusively by industry, were interventions （94.6%）, examined drugs （87%） and enrolled exclusively adults （86%） of both genders （89%）. Only 383 （19%） of multinational stud-ies and two （4.4%） of exclusively Russian studies werepublished. Posting of patient outcomes was available for 16% of the trials that recruited trial participants in the Russian territory including one study funded exclu-sively by Russian sponsors. Investigators terminated 99 studies of 38111 participants and did not provide the results in clinicaltrials.gov or in published manuscripts. Federal laws require clinical study registration and con-fict of interest disclosure. However, routine monitoring of compliance to clinical research policy is not available.CONCLUSION： Russian legislation does not guarantee the availability of clinical research results. Russian leg-islation should mandate transparent evidence- based market approval of the drugs and devices.

Necessities and feasibilities of the establishment of traditional Chinese medicine clinical research protocol database

With the internationalization and modernization of traditional Chinese medicine （TCM）, TCM clinical research has accumulated a lot of research information resources. However, these information resources are often scattered in various retrieval systems, which brings some difficulties to the reference and use of this information. Therefore, we collected TCM clinical research protocols which were published in international journals and established Traditional Chinese Medicine Clinical Research Protocol Database （TCMCRPD）, in order to promote the localization of high-quality researches and improve the ability of TCM clinical research in China. After analyzing the major existing problems of TCM clinical research protocols, this essay describes the necessities and feasibilities of building Traditional Chinese Medicine Clinical Research Protocol Database （TCMCRPD） and puts forward some basic technological ideas, so as to provide a theoretical foundation for building the database.

Synergetic role of integrating the departments of cancer registry and clinical research at an academic comprehensive cancer center

Integration of the cancer registry and clinical research departments can have a significant impact on the accreditation process of a Commission on Cancer(Co C) Program.Here in we demonstrate that the integration of both departments will benefit as there is increased knowledge, manpower and crossover in job responsibilities in our Co C-accredited Academic Comprehensive Cancer Center.In our model this integration has led to a more successful cooperative interaction among departments, which has in turn created an enhanced combined effect on overall output and productivity.More manpower for the cancer registry has led to increased caseloads, decreased time from date of first contact to abstraction, quality of data submissions, and timely follow-up of all patients from our reference date for accurate survival analysis along with completeness of data.In 2016, our Annual Facility report showed an additional 163 cases over prediction by the state of Maryland Cancer Registry and a 39% increase in case completeness.As proof of the synergetic effectiveness of our model within one year of its implementation, the cancer center was able to apply for, and was awarded membership from Alliance for Clinical Trials in Oncology, Central IRB, and in turn led to increased clinical trial accrual from 2.8% in 2014 compared to 13.2% currently.Our cancer registry in year one submitted over 150 more cases than predicted, improved quality outcome measures displayed by our Cancer Program Practice Profile reports and had more timely and complete data submissions to national and state registries.This synergetic integration has led to a better understanding, utilization and analysis of data by an integrated team with Clinical Research expertise.

Economic Impact of Clinical Research to Research Centers and Opportunity Cost for the Reimbursement System in Turkey

Introduction: Clinical research is a key component of drug development with a significant economic value. It has been reported that the development of a new molecule requires 10 - 15 years and costs almost $1.3 billion. Around 75% of the cost is spent on the Phase I-IV clinical research process. This study aimed to show the economic value of clinical research in Turkey. Methods: Clinical trial budgets were estimated from the raw data of the Report of Istanbul Medical Faculty Clinical Research (ITFKAR). In the research, the estimated cost of drugs used in the clinical trials for the Turkish reimbursement agency (SGK) was calculated to show the cost of medicines acquired through clinical research. Results: The total budget for sponsored pharmaceutical research was $107 million in Turkey, and the government saved close to $311,096,130 during 2006-2010, due to not reimbursing the patients for the drugs in the clinical trials. Conclusion: Despite the limitations of the study, the findings are unique for Turkey. The results can lead to revisiting the importance and economic value of clinical trials in Turkey.

Patient-centric periodontal research:A pioneering application of patient-reported outcome measures

Conventional dentistry or periodontal research often ignores the human component in favor of clinical outcomes and biological causes.Clinical research is driven by the statistical significance of outcome parameters rather than the satisfaction level of the patient.In this context,patient-centric periodontal research(PCPR)is an approach that considers the patient´s feedback concerning their functional status,experience,clinical outcomes,and accessibility to their treatments.It is argued that data self-reported by the patient might have low reliability owing to the confounding effect of their personal belief,cultural background,and social and economic factors.However,literature has shown that the incorporation of“patient-centric outcome”components considerably enhances the validity and applicability of research findings.Variations in the results of different studies might be due to the use of different and non-standardized assessment tools.To overcome this problem,this editorial enlists various reliable tools available in the literature.In conclusion,we advocate that the focus of researchers should shift from mere periodontal research to PCPR so that the results can be effectively applied in clinical settings and the therapeutic strategy can also change from mere periodontal therapy to patient-centric periodontal therapy.

Clinical research of acupoint application for "treatment of winterdisease in summer" used to prevent and treat bronchial asthma inchildren

OBJECTIVE:To preliminarily analyze key factors influencing curative effect through clinical observations of acupoint application for "treatment of win-ter disease in summer" used to prevent and treat bronchial asthma in children.METHODS:In an observational study and prospective cohort study,we observed children in remission of asthma at three class Ⅲ grade A TCM hospitals in Liaoning,Hubei,and Chengdu.RESULTS:A total of 609 children conformed to diagnostic and inclusive standards for remission of bronchial asthma.Through follow-up visits,we observed their skin reactions and the time and chance of treatment with different therapies in the three hospitals;we also compared and analyzed different drugs,acupoints,and preparations.We found that the key Chinese drugs were Bai Jie Zi(Semen Sinapis Albae) and Yian Hu Suo(Rhizoma Corydalis);the key acupoints were Feishu(BL 13),Gaohuang(BL 43),Dingchuan(EX-B1),Tiantu(CV 22),and Shanzhong(CV 17);and the best preparation was a mixture of drugs,ginger juice,and musk.Acupoint application was practiced on the hottest days of summer and the coldest days of winter for 0.5 to 2 h with the lowest rate of asthma relapse.CONCLUSIONS:The present data analysis shows that the curative effect of acupoint application for "treatment of winter disease in summer" may be influenced by recipes of Chinese drugs,preparations,prescriptions of acupoints,chance,time,and skin reactions.A curative effect is the result of the comprehensive action of these factors.