In order to fully implement the ethical principles of biomedical researches and to better safeguard the legitimate rights and interests of the subjects, this paper begins from the research design and closely combines with the ethical practice of biomedical research review, seriously analyzes the key implementation points of the ethical free and compensation principles in biomedical research, including intervention study, random allocation, follow-up research and new medical techniques and so on, also will provide the beneficial reference for comprehensive formulation of enforcement regulation of ethics principle of biomedical research in the future.
Poor compliance in clinical studies is a risk factor leading to bias of results of clinical research. However, while the subject compliance has received extensive attention, researcher compliance has not been paid enough attention. The problem of researcher compliance runs through the whole process of clinical research. How to control and evaluate the researcher compliance is the key problem in clinical research. Based on the current situation of poor compliance of clinical researchers, this paper summaried the information of five different dimensions that affects the researcher compliance in clinical research, clarified the relevant factors that may affect the researcher compliance in the process of clinical research, and analyzed the influence of the factors related to the researcher compliance on the quality control of clinical research, hence establishing a foundation for further research on control strategies and evaluation techniques of researcher compliance.
In recent years, clinical research shows the trend of globalization. Due to characteristics of the huge number and relative concentration of patients, the wide variety of diseases, a high patient enrolment rate, lower trials costs, and so on, China and India become a focus of this trend. However, China and India also have their own advantages in the aspects of diseases, infrastructure, policies, regulations, regulatory environment, language, and culture. The key question to address is: how to increase the shares in the trial market in the future and to enhance the international status of China’s clinical research? Before we answer this question, we must understand the present situations of clinical research resources in China and India. So, we searched the relevant literature at home and abroad by computer and hand to analyze advantages and efficiency of clinical research resources in China and India.
Repeated measurement quantitative data is a common data type in clinical studies, and is frequently utilized to assess the therapeutic effects of the intervention measures at a single time point in clinical trials. This study clarifies the concepts and calculation methods for sample size estimation of repeated measurement quantitative data, in order to explore the research question of "comparing group differences at a single time point", from three perspectives: the primary research questions in clinical studies, the main statistical analysis methods and the definitions of the primary outcome indicators. Discrepancies in sample sizes calculated by various methods under different correlation coefficients and varying numbers of repeated measurements were examined. The study revealed that the sample size calculation method based on the mixed-effects model or generalized estimating equations accounts for both the correlation coefficient and the number of repeated measurements, resulting in the smallest estimated sample size. Secondly, the sample size calculation method based on covariance analysis considers the correlation coefficient and produces a smaller estimated sample size than the t-test. The t-test based sample size calculation method requires an appropriate approach to be selected according to the definition of the primary outcome measure. The alignment between the sample size calculation method, the statistical analysis method and the definition of the primary outcome measure is essential to avoid the risk of overestimation or underestimation of the required sample size.
Stem cell transplantation is one of the main methods to treat thromboangiitis obliterans (TAO). In recent years, research on the treatment mechanism of stem cell transplantation has made some progress. The results of a number of stem cell clinical trials specifically for TAO have been published. Some new stem cell types have gradually been used in the clinic. There is no major dispute over security. In addition, research shows that the efficacy of stem cell transplantation is affected in many ways, and some factors have a certain predictive effect on the possibility of amputation after transplantation. This paper reviews the clinical research progress of stem cell transplantation for TAO, and aims to provide some basis for the better use of stem cell transplantation in the treatment of TAO.
This article reviewed other literatures in the quality management of clinical trials and summarized author’s experience in quality control of clinical trials which the author conducted as principle investigator over the past years. It provides a reference for fresh investigators before they conduct their own clinical trials.
Mixed methods research (MMR) is the third research paradigm that combines quantitative and qualitative research. MMR can overcome limitations of qualitative and quantitative methods by integrating the advantages of these two. The environment of real world research is complicated. When using real world data to assess the health status of patients, process of treatment, outcomes of prevention and treatment, prognosis and prediction, and support for medical policy development, MMR can be applied to tackle research questions more comprehensively for the quality of research.
Objective To analyze the therapeutic effect of olfactory ensheathing cells (OECs) transplantation for central nervous system diseases. Methods Between November 2001 and January 2008, 1 255 participants with central nervous system diseases were enrolled in this cl inical study for fetal OECs transplantation. There were 928 males and 327 femalesaged 1.2-87 (mean 40) years. The course of disease was (4.52 ± 4.67) years. Among them, 656 participants suffered from chronic spinal cord injury (SCI), 457 amyotrophic lateral sclerosis (ALS), 68 cerebral palsy (CP), 20 multiple sclerosis (MS), 11 the sequelae of stoke, 10 ataxia, and 33 residual diseases. The participants came from 71 countries or regions. Accidentally abortional fetal olfactory bulbs were donated voluntarily and were cultured for 2 weeks, then were transplanted. Results One thousand one hundred and twenty-eight cases were followed up for 2-8 weeks (mean 4 weeks) to obtain integrated data. Among them, the neurological functional amel ioration was noticed in 994 participants with the overall short-term improvement rate of 88.12%. Seventy-six patients experienced the various perioperative compl ications with the incidence rate of 6.74%. One hundred and twenty patients with SCI received over 1 year follow-up. And according to ASIA assessment, motor scores increased from (39.82 ± 20.25) to (44.55 ± 18.99) points, l ight touch scores from (51.56 ± 25.89) to (59.81 ± 27.72) points, pain scores from (50.36 ± 27.44) to (57.09 ± 28.51) points for foreign patients (P lt; 0.05); motor scores increased from (40.52 ± 20.80) to (46.45 ± 20.35) points, l ight touch scores from (55.64 ± 26.32) to (68.64 ± 25.89) points, pain scores from (57.05 ± 26.00) to (66.13 ± 24.29) points for good rehabil itation Chinese patients (overall P lt; 0.05); motor scores from (37.03 ± 18.52) to (38.03 ± 18.50 points (P lt;0.05), l ight touch scores from (45.88 ± 22.56) to (46.63 ± 23.09) points (P gt; 0.05), pain scores from (45.25 ± 23.68) to (45.28 ± 23.63) points (P gt; 0.05) for poor rehabil itation Chinese patients. Compared foreign patients and good rehabil itation Chinese patients with poor rehabil itation Chinese patients, difference in score change was remarkable (P lt; 0.05). One hundred and six cases of ALS, 32 CP, 8 MS, 7 ataxia, and 2 stroke sequelae were followed up for 3-48, 3-36, 2-20, 7-17, 6 and 24 months, One hundred and six cases of respectively. Majority of them (113/155, 72.9%）were benefited from OECs transplantation. Conclusion OECs transplantation into brain and spinal cord is feasible and safe . The therapeutic strategy is valuable treatment for such central nervous system diseases such as chronic SCI, ALS, CP and stroke sequelae and can improve the patients’ neurological functions and/or decrease the progressive deterioration.
Epilepsy is a common chronic disease of the nervous system, which has certain adverse effects on the cognitive, psychological and social functions of the patients. To date, anti-seizure medications (ASMs) remain the first-line treatment option for epilepsy, but many patients with epilepsy still do not have effective seizure control when multiple ASMs are used in combination. Therefore, there is an urgent need for a new target and mechanism ASMs to bring about new treatment options and hope for patients with intractable epilepsy. Perampanel, a new third-generation ASMs, whereas second-generation ASMs tend to exert anti-seizure effects mainly by regulating ion channels or enhancing related mechanisms such as gamma-aminobutyric acid (GABA) effects, perampanel exerts its effects mainly by targeting the excitatory neurotransmitter glutamate. Perampanel is the first selective α-amino-3-hydroxy-5-methyl-4-isoxazole-propionate (AMPA) receptor antagonist and the first selective inhibitory ASMs for excitatory postsynaptic function. Because of its unique target and mechanism, it has been approved by many countries in the world for adjuvant additive therapy and monotherapy for patients with focal and general epilepsy. In addition, with the discovery of the neuroprotective, antioxidant, neurotransmitter regulation effects of perampanel, it also provides a new potential choice for the treatment of other diseases. This article mainly reviews the mechanism of action, pharmacokinetics, clinical trials and treatment of other diseases other than epilepsy of perampanel.