Establishing and improving the quality control system of drug clinical trial institutions is the key to ensure the quality of clinical trial. In recent years, the number of drug clinical trial has been continuously improved, and the quality control requirements have been continuously improved. However, in clinical work, the workload of medical staff is heavy, and the energy devoted to clinical trial is limited. Clinical research coordinator (CRC), as a participant and coordinator of clinical trial, has carried out transactional work related to non-medical judgment under the authorization and guidance of researchers, and has undertaken any specific work in clinical trial. Based on the quality control management experience of nosocomial CRC and hospital drug clinical trial institutions in West China Hospital of Sichuan University, this paper discusses the mode of nosocomial CRC participating in clinical trial quality control. By participating in the quality control of clinical trial, the nosocomial CRC has improved the quality control efficiency, enriched the quality control team and improved the overall level of CRC. This model enriches the quality control system of drug clinical trial.
Objective To describe pharmacokinetic of imatinib in a cohort of gastrointestinal stromal tumor (GIST) patients in routine clinical care from West China Hospital of Sichuan University. Methods The imatinib trough concentration (Cmin) in 42 patients with GIST who were taking imatinib in routine clinical care setting in West China Hospital from 2010 to 2016 was measured. The clinical features and follow-up data were collected. Results The mean imatinib Cmin in 42 patients was 1 757 μg/L (199–7 435 μg/L), 10 of 42 patients presented with Cmin values was lower than 1 000 μg/L. The imatinib Cmin of 18 patients received an imatinib dose of 300 mg/d or 24 patients treated with 400 mg/d imatinib was (1 313±479) μg/L and (1 775±1 520) μg/L, respectively (P=0.222), but the rate of low Cmin (lower than 1 000 μg/L) in the two different dose groups had no significant difference (P=0.347). In Cox regression, no statistically significant association between the low Cmin and the time to progression of GIST could be demonstrated 〔HR=0.171, 95%CI：(0.106, 12.990),P=0.898〕. Conclusion The preliminary results of limited cases in this study show that some GIST patients are systematically underexposed in routine clinical care, an individualized treatment based on monitoring of imatinib Cmin is likely to be more efficient than a fixed-dose treatment.
Objective To compare the systematic and lung pharmacokinetic parameters of moxifloxacin hydrochloride and explore a feasible tool to monitor drug concentration and evaluate therapeutic efficacy of respiratory fluoroquinolones. Methods Ten adult patients with community-acquired pneumonia or acute exacerbation of chronic bronchitis were enrolled.The subjects received a single dose of oral moxifloxacin hydrochloride 400 mg. Serum specimens were sampled at 0，1，2，3，4，8，24 h and sputum specimens were collected 0，1，2，4，8，20，24 h after administration，respectively.The serum and sputum concentrations of moxifloxacin hydrochloride were assayed by means of high-performance liquid chromatography. Standard pharmacokinetic parameters including peak concentrations(Cmax) and area under the concentration-time curve (AUC0-24 h) were assessed. Results Serum C(max) was（5.95±1.35）mg/L at 2 hours and serum AUC0-24 h was (58.72±8.11）mg·h-1·L-1 while sputum Cmax and AUC0-24 h were （16.18±6.47）mg/L at 3 hours and （138.04±78.29）mg·h-1·L-1 respectively，which were significantly higher than those in serum. Conclusion Oral administration of moxifloxacin hydrochloride to patients with respiratory infections results in rapid penetration into lung and maintain a one-fold drug concentration compared to blood concentration within 24 hours.Sputum drug concentration analysis demonstrates a superior pharmacokinetic profile of moxifloxacin in respiratory tract.
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.
