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Ethical review is an important protective measure for research participants when conducting life sciences and medical research involving humans. "Exemption from ethical review" was proposed in The Measures for Ethical Review of Human Life Sciences and Medical Research Involving Humans issued in February 2023. To implement the exemption from ethical review within the permitted scope of laws and regulations, and to protect the privacy and rights of research participants when utilizing their data information and biological samples, multiple factors need to be considered, including the person responsible for exemption from ethical review, the conditions for exemption from ethical review, and the specific process for exemption from ethical review. As with other review procedures, exemption from ethical review also required the development of corresponding systems, implementation of responsibilities, and reliance on the construction of subject protection systems. It is hoped that this discussion can provide considerations for the implementation of exemption from ethical review.
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According to the Ethical Review Measures for Life Sciences and Medical Research Involving Humans jointly issued by the National Health Commission, the Ministry of Education, the Ministry of Science and Technology and the State Administration of Traditional Chinese Medicine in 2023, to optimize the ethical review process and reduce the burden on clinical researchers, it is proposed that some eligible situations can be "exempted from ethical review". This is a breakthrough progress in China’s ethical review management measures that firstly aimed at "exemption from ethical review". This paper reviewed and sorted out the relevant situations about exemption from review at home and abroad, focused on analyzing and exploring the four situations of exemption from review, especially discussed and analyzed the understanding of anonymization and personal sensitive information in exemption from review, and proposed practical suggestions for the four situations. Based on the actual situation of ethical review work, this paper also explored the establishment of practical standards and processes for exemption from review, providing reference for other medical institutions to implement the exemption from ethical review process.
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Objective:To explore the development, application and practical experience of investigator-initiated integrated clinical research information platform.Methods:The process of developing and constructing an integrated clinical research platform in a tertiary hospital in Beijing was introduced, the functions and advantages of the platform were described and displayed, and the main problems and risk points in the development and construction process were analyzed.Results:The integrated clinical research platform meets the management requirements of clinical research initiated by investigators, and the standardized management of the whole life cycle of the project can be realized through the platform, and the key issues of data security, information capture, sharing and interoperability need to be further explored in terms of platform docking.Conclusions:The integrated clinical research platform effectively improves the standardization, management quality and efficiency of investigator-initiated clinical research.
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Objective:To provide decision-making support for electronic informed consent selection and promotion in clinical research, and lay a possible theoretical foundation for better protection of subjects′ rights and interests, as well as promotion of clinical research quality and efficiency.Methods:This paper summarized the relevant laws and regulations of electronic informed consent, analyzed the advantages and challenges of the application of electronic informed consent in clinical research, sorted out several common electronic informed consent modes in domestic clinical research, explored their operational processes and applications, and discussed their advantages and limitations.Results:At present, three electronic informed consent modes were mainly used in domestic clinical studies. Each had their own advantages and limitations in terms of convenience of operation, data security, privacy protection of subjects, cost input, popularization degree and so on.Conclusions:Electronic informed consent needs continuing improvement of relevant laws and regulations and the joint efforts of all stakeholders engaged in clinical research. The sponsor and the researcher should take full consideration of the cost, safety, security, feasibility, and ofters, and make the selection according to the actual needs of the research.
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Objective To describe the characteristics and registration status of clinical trials of new drugs for nonalcoholic steatohepatitis (NASH), and to provide a reference for the design and implementation of clinical trials of new drugs for NASH. Methods The U.S. Clinical Trials Database, China Clinical Trial Registry, and Center for Drug Evaluation, National Medical Products Administration, were searched for clinical trials of new drug registration and interventional studies with NASH as the indication published up to August 6, 2021, using NASH in English and Chinese characters as the keywords, and liver cirrhosis was excluded. Two researchers independently searched and screened the articles to extract relevant information. Results A total of 196 clinical trials of new drug registration or interventional studies for NASH were included, among which there were 174 trials registered abroad and 22 trials registered in China, and the number of registrations tended to increase year by year. The numbers of phase Ⅰ, phase Ⅰ/Ⅱ(including Ⅰb/Ⅱa), phase Ⅱ, phase Ⅱ/Ⅲ, and phase Ⅲ clinical trials were 45(23.0%), 8(4.1%), 112(57.1%), 4(2.0%), and 19(9.7%), respectively. The main drug types included farnesoid X receptors, fibroblast growth factors, peroxisome proliferator-activated receptor agonists, and glucagon-like peptide-1, with numbers of 16(8.16%), 14(7.14%), 11(5.61%), and 13(6.63%), respectively. The clinical trials of innovative drugs for NASH initiated by the sponsors in European and American regions accounted for the highest proportion, and there was a gradual increase in the number of clinical trials of innovative drugs in China in recent years, with a similar distribution of single-center and multicenter clinical trials. As for the trials with NASH patients as subjects, the numbers of trials with pathology, imaging, and clinical diagnosis as the main inclusion criteria were 125, 66, and 42, respectively. Phase Ⅰ clinical trials used safety, tolerability, and pharmacokinetic parameters as the main assessment indices, while phase Ⅱ and phase Ⅲ clinical trials often used safety and efficacy as the main assessment indices. The number of clinical trials for the registration of innovative drugs for NASH was relatively low but kept increasing in China, and there were fewer clinical trials of innovative traditional Chinese medicine drugs compared with innovative chemical drugs. Conclusion There is a significant increase in the registration of international clinical trials of innovative drugs for NASH, and most of these trials are in the early phases, with large differences in inclusion criteria and assessment indices, a lack of unified evaluation indices, and relatively few trials with new designs. There are fewer clinical trials of innovative drugs for NASH in China than in European and American countries, and the number of such trials is gradually increasing in China.
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Objective To assess the prognostic value of the serum level and its change of N-terminal pro-B-type natriuretic peptides(NT-proBNP)in the elderly with acute decompensated heart failure with preserved ejection fraction(HFpEF). Methods A total of 138 consecutive patients(≥ 65 years old) admitted in Geriatrics and Gerontology Department at Beijing Friendship Hospital were enrolled from June 2013 to June 2015.Demographic characteristics,combination of diseases,medication administration, laboratorial and echocardiographic data were recorded.Meanwhile,NT-proBNP levels at admission,7thday after admission,changes over 7 days were also recorded and calculated.At the end of 1 year follow up,all patients were divided into events group(n=72)with,and control group(n=66)without,adverse outcomes of heart failure death,heart failure readmission and all-cause death.The differences in NT-proBNP level at admission,7thday after admission,and its changed value and rate over 7 days were compared between the two groups.Logistic regression was used for analysis of independent risk factors for prognosis.And the cut-off points of NT-proBNP values to predict adverse events were determined by receiver operating characteristic (ROC)curve. Results NT-proBNP values were significantly higher at admission and at 7thdays after admission in the events group than in control group(P=0.000).There were no significantly differences in NT-proBNP level and its changes over 7 days between two groups(P= 0.370 and P= 0.272).Logistic regression analysis showed that NT-proBNP values at admission and 7thdays after admission,and NYHA functional classification were independent risk factors for adverse outcomes in 1 year in the elderly with HFpEF(all P<0.05).Furthermore,by the ROC curve,NT-proBNP values at admission and 7thdays after admission could predict adverse outcomes including composite endpoints of heart failure,re-admission,heart failure associated death,and all-cause mortality in 1 year. Conclusions Both the plasma NT-proBNP levels at admission and at 7thdays after admission have a correlation with prognosis in elderly patients with acute decompensated HFpEF,while changes of NT-proBNP concentration over 7 days could not predict adverse outcomes in this cohort.
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A 77-year-old man was admitted to our hospital at July 5th,2010 with an unexplained massive pericardial effusion for 10 years.With dyspnea for one month and normal vital signs without pulsus paradoxus,other physical examination included a small amount of moist rale,normal heart sounds,jugular vein engorgement,positive hepatojugular reflux,hepatosplenomegaly and pitting edema of the extremities.The patient had a complex past history with lymph node tuberculosis,primary artertial hypertension,polycythernia vera,chronic renal insufficiency and hypothyroidism (Hashimoto's thyroiditis),and moreover,received a high dose radiation of 31p in 1967. Family history is negative.The patient had no cardiac tamponade or pericardial constriction during 10 years,he received pericardiocentesis twice,and pericardial effusion was exudative with a high proportion of monocyte.There was no evidences of tuberculosis infection,hypothyroidism,malignant tumor,severe heart failure,uremia,trauma,severe bacterial or fungus infection,chronic myeloid leukemia or bone marrow fibrosis during the admission. The patient refused anti tuberculosis,indwelling catheter drainage or surgical therapy.In this rare case,the aetiology of chronic massive pericardial effusion is most probably chronic idiopathic recurrent pericarditis.