This study summarizes the practical experience of remote monitoring in clinical trials, preliminarily discusses the advantages and consideration factors, and provides reference for monitoring and management of clinical trials.

In view of the problem that on-site monitor cannot be conducted on time during the COVID-19, our hospital launched the online remote monitoring system in time relying on the DPAP technology for the use of sponsor and CRO. The application of remote monitoring by September 15, 2020 were counted through the system backstage. The effect of application was objectively evaluated by comparing the defect detection rate per subject found by remote monitoring and on-site monitoring with chi-square. The user experience, advantages and disadvantages of remote monitoring system were investigated through homemade questionnaire and in-depth interview. The method of health economics evaluation was used to estimate the cost of simple on-site monitoring mode, remote monitoring and on-site monitoring combined mode.

The hospital officially launched the remote monitoring system on February 10, 2020. Until September 15, 2020, 176 CRAs from 76 sponsors/CRO have used the remote monitoring system for totally 10 470 times to conduct remote monitoring, involving 228 projects, 1 318 subjects, 16 departments in our hospital. A total of 3 820 findings have been found during the remote monitoring of 228 trials. Compared with the on-site monitoring of the same project in 2019, the remote monitoring achieved the on-site monitoring effect in terms of checking protocol deviation, case report form (CRF), combined drug use and biological samples; however, it is not as good as the on-site monitoring in terms of original records, informed consent, adverse events and experimental drugs, which involves more paper materials. 72.61% of CRAs believed that remote monitoring system effectively supported the completion of monitoring work, and 62.50% of CRAs thought that it reduced the time of on-site monitoring. The in-depth interviews with 16 CRAs showed that remote monitoring had advantages and was highly praised. The cost of the combination of routine on-site monitoring visit, remote monitoring and on-site monitoring was calculated, resulting that on-site monitoring visit frequency was reduced by 16 times, saving 73 600 RMB of travel expenses and 624 hours of travel time. But remote monitoring should be considered and standardized in system verification, subject informed consent monitoring and privacy protection, data security, implementation and other aspects.

The remote monitoring mode made the monitoring free from location and time constraints, timely found the problems in the trials, greatly improved the efficiency of the monitoring, and reduced the risk and cost of clinical trials. In the future, it can be applied and explored in more aspects, but still needs to be further supplemented with data sources and standardized in the aspects of system verification.

The purpose of this study is to investigate the status of experimental drug management in pediatric clinical trial institutions in China, provide a basis for administrative departments and institutions to formulate standardized management policies for pediatric clinical trial drugs, as well as establish and improve a pediatric clinical trial drug management system.

Questionnaire survey was conducted in 16 pediatric clinical trial institutions registered in Chinese Pediatric Population Clinical Trial Collaboration Network. Statistics and analysis were conducted on the survey data to make recommendations.

A total of 16 questionnaires were distributed, and 16 valid questionnaires were recovered. The questionnaire recovery rate was 100% and 16 questionnaires were recovered with an efficiency of 100%. The basic situation of trial drug management in various institutions is satisfactory, but there is still improvement room for the management model, software and hardware investment, staffing, incentive mechanism, as well as budget management.

The investigation results well reflect the current situation of drug administration in pediatric clinical trial institutions in China. At present, the development of experimental drug management should focus on perfecting the drug management mode, increasing the investment in hardware and software, optimizing the professional staffing, improving the performance distribution system and personnel incentive mechanism, and strengthening the management of experimental drug budget evaluation.

To investigate the influencing factors of weight control level of meclofenoxate hydrochloride for injection, and establish the quality control method based on laser diffraction particle size analysis.

The sources of APIs, types of packaging equipment and debugging methods of preparations from different companies were investigated by telephone survey. The crystal form was determined by powder X-ray diffraction. Laser diffraction particle size analysis was used to determine the particle size and particle size distribution, and the diameter was calculated.

For the meclofenoxate hydrochloride for injection produced by direct packing of API, the excessive spans of API and improper bugging methods of packaging equipment were the direct causes of product non-conformity. There was a positive correlation between the span and the RSD value of weight.

This study reasonably explained the reasons for the unqualified weight and content of meclofenac hydrochloride injection and proposed a practical method for the improvement of the production process of the enterprise and a scientific and feasible control acceptance method for the bulk drug used in the packaging, which provides a strong technical support for improving the quality of medicines and reducing the risk of clinical medication.

To explore the application effect of whole process quality control in phase Ⅰ clinical trial management.

A total of 96 subjects and 40 research nurses were included in the clinical trial. The group before the implementation of whole-process management (2018-01—2019-01) was regarded as the control group, and the traditional phase Ⅰ clinical trial management process was implemented. The group before the implementation of the whole process management (2019-06—2020-06) was regarded as the research group, and the implementation of the whole process quality control. Scale analysis was used to compare the compliance, shedding rate and satisfaction of the two groups of subjects. The management knowledge was evaluated.

The compliance of the study group was significantly higher than that of the control group (t=11.41, P<0.001). The drop off rate of the study group was significantly lower than that of the control group (χ²=3.215, P=0.036), and the satisfaction of the study group was significantly higher than that of the control group (t=8.984, P<0.001). The nursing staff management standard, nursing related standard operating procedures, first aid skills, practical skills, medical record writing, quality control related knowledge of the study group were better than those of the control group.

The implementation of whole process quality control in phase Ⅰ clinical trial quality management can improve the quality of phase Ⅰ clinical trial, improve the quality of nursing, and protect the rights and interests of subjects.

Tissue distribution after single and repeated doses in rats was compared by quantitative whole body autoradiography technique (QWBA) to guide the design of human radioactive mass balance study.

Male Long Evans (LE) rats were given, by gavage, 0, 7 and 14 doses (once a day) of non-radiolabeled drug VPS-01, at 15 mg·kg^-1, followed by a single dose of [¹⁴C]VPS-01 at 100 μCi/15 mg·kg^-1, po, at 24 h post last non-radioactive dose (defined as 0+1, 7+1 and 14+1 groups, respectively). And then, after 3, 24, 168 and 504 h of radiolabeled drug administration, one rat from each group was sacrificed and carcasses were collected and frozen immediately, followed by sliced using Leica CM3600 XP. After proper treatment, the radioactivity level of each tissue and region of interest in the slices were obtained by phosphorus imaging technology.

The total radioactivity of VPS-01 and/or its related metabolites was observed bound to melanin. Compared with 0+1 group, the radiation concentration and exposure of rats in 7+1 group significantly reduced, and the maximum radiation dose of [¹⁴C]VPS-01 in humans could accordingly increase from 61.6 μCi to 611 μCi. However, no significant difference of exposure was observed between 14+1 group and 7+1 group.

Drugs with slow elimination due to tissue covalent binding are easy to result in high radiation exposure in the human body in the mass balance study. If the subjects are given non-radiolabeled drugs repeatedly for several times to reach a steady state in human body before a single dose of the ¹⁴C-drug is given, the radiation exposure of subjects can be significantly reduced, the optional range of human radiation dose can be increased, and the radioactivity in the circulating blood will be increased, facilitating metabolite identification.

To design and synthesize twin drug of tetramethylpyrazine and scutellarein for ischemic stroke.

Based upon the theory of twin drug, six targeted compounds were synthesized and their structures were confirmed by ¹H-NMR and HRMS. The antioxidant and anticoagulant activities of the target compounds were studied in vitro, and the selected compound was further evaluated for cerebral ischemia/reperfusion protection using middle cerebral artery occlusion (MCAO) model.

All the tested compounds showed good effect against oxidative damage and anticoagulant activity, and the volume ratio of cerebral infarction in the high dose group of compound 4 was reduced to 23.7% compared with the MCAO group.

The twin drug strategy has certain reference value for the treatment of ischemic stroke.

To investigate the local anaesthetic effect and volatile composition of the extracts of Zanthoxylum bungeanum and processed products.

Pepper samples were processed by four different processing methods: frying, vinegar, salt and wine. The difference of infiltration anesthesia effect of different extracts of pepper was studied and analyzed by GC-MS. The processing method of pepper obtaining best local anesthesia effect was selected and the composition and its changes of active parts were analyzed.

The effects of different pepper extracts on guinea pigs were significantly different. When the drug concentration was 0.2 g·mL^-1, the anesthesia time of different peppers was longer than 40 min, and the anesthetic effect was dose-dependent. The order of local anesthesia effect from strong to weak is: vinegar products > lidocaine hydrochloride > raw pepper > fried products > salt products > wine products. A total of 24 components were detected by GC-MS in ether extracts of different Zanthoxylum bungeanum products, which were roughly divided into three categories: alcohols, alkenes and esters. The four compounds in the highest content were: linalyl acetate, limonene, 3-decene and linalool.

The ether extracts of different products of Zanthoxylum bungeanum have better infiltrative and anesthetic action, and the effect of the vinegar product is better than that of the positive control lidocaine hydrochloride, and the specific mechanism of action is to be further studied.

To assess the general patterns and characteristics of adverse drug reactions (ADRs) induced by new antitumor drugs and provide reference for clinical medicination.

A total of 54 cases of ADR induced by new antitumor drugs were collected from January 2015 to December 2019 in Bengbu Adverse Drug Reaction Center, and analyzed statistically.

In the 54 ADR cases, male patients were more than females. The majority of the patients with ADR were over the age of 51 (n=45, 83.3%). The ADR cases were related to 15 kinds of new antitumor drugs, of which the drug rituximab was the one that caused the most ADR. The main consequences of these ADR cases involved following damages: skin and its accessories damage (19.8%) and digestive system damage (17.3%).

New antitumor drugs have been widely used in clinical. Clinicians and pharmacists should reinforce the monitoring on its using to ensure the safe and effective clinical application of new antitumor drugs.

To analyze the general patterns and characteristics of blood coagulation dysfunction induced by tigecycline and provide reference for clinical use.

Blood coagulation dysfunction induced by tigecycline reported in foreign and domestic academic journals were collected from China National Knowledge Infrastructure (CNKI), VIP, PubMed, Embase and SCI, and analyzed in depth.

A total of 17 patients, including 12 males and 5 females, were retrieved, and 5 of whom with abnormal liver function. Among them, 10 patients appear coagulation dysfunction in 10 d of treatment. The clinical manifestations of blood coagulation dysfunction induced by tigecycline were the significant prolongation of prothrombin time (PT), activated partial thromboplastin time (APTT) and fibrinogen (FIB) significantly decreased. After treatment, 16 patients recovered and 1 died.

Clinicians and pharmacists should familiarize the pauem and characteristics of blood coagulation dysfunction induced by tigecycline, which should be used strictly in accordance with the instructions. Drug monitoring should be strengthened.