ABSTRACT
OBJECTIVE： To put forward the suggestions for improving drug management in clinical drug trials in China. METHODS： “Good clinical practice” “Clinical trials drug” “Drugs for clinical trials” “GCP” “Investigational drug products” as search terms， searching CNKI database， Wanfang database， PubMed database and OVID electronic journal full-text database during Jul. 2014-Jul. 2018. The differences of drug management guidelines and management systems （including management model， staffing and budget evaluation） in clinical drugs between China and the United States were summarized. The suggestions were put forward to the shortage of drugs management of clinical trials in China. RESULTS & CONCLUSIONS： A total of 154 literatures were retrieved， including 33 valid literatures. The guidelines for drug management in clinical trials in the United States were relatively perfect， such as the Guidelines for Drug Management in Clinical Trials promulgated by the American Society of Hospital Pharmacists， while China had not yet published such national guidelines. The drug management in clinical trials in the United States had two modes which is the management of part-time pharmacists in hospital pharmacy department and the management of several full-time pharmacists and pharmacy technicians. Pharmacists or pharmaceutical technicians participated in the whole process of management， and a lot of research was carried out on the budget evaluation of clinical trials drug management. Domestic clinical trials drug management included three modes which is full-time pharmacist management， full-time pharmacist and part-time nurse management， part-time pharmacist and part-time nurse management. Pharmacists and nurses jointly participated in the management， but the whole process management had not yet been achieved， and there were few studies on budget evaluation of clinical trials drug management. It is suggested that the management of clinical trials drug in China can improve the management efficiency and level of clinical trials drug by refining the management system of clinical trials drug， standardizing the management mode of clinical trials drug and carrying out management budget evaluation.
ABSTRACT
Objective To investigate the awareness,willingness,motivation,and influencing factors of outpatients for participating drug clinical trials,and provide references for decision-making of drug clinical trials.Methods An amnonymous survey was conducted in the departments of internal medicine,surgery,gynecology,and obstetrics of a randomly selected tertiary referral center,and the results were statistically analyzed.Results A total of 1 067 available questionnaires were received.The total awareness rate of clinical trials was 31.02％,which was closely correlated with age and the degree of education.40.86％ of respondents were willing to participate in drug clinical trials.And 55.28％ of them chose yes because of the willingness to contribute to the development of medical science.People having cognition on clinical trials had more willingness to participate in drug(OR:1.361,95 ％ CI:1.042-1.777).59.14％ of the respondents refused to participate in drug clinical trials,68.62％ of whom refusing to participate mainly worried about the safety of drugs.57.37％ of the respondents comfirmed that they might change their idea if experts were involved.41.33％ were willing to accept training about clinical trials.Conclusion Investigators'overall cognition on clinical trials is closely correlated with the willingness to participate in drug clinical trials.There should propagandize drug clinical trials to make sure the improvement of drug clinical trial progress.