Study On Cognition,Attitude And Factors Of Health Providers And Parents To Children’s Clinical Trials In Chongqing

Objective: Under the background of lacking specific medicine for children, common phenomena of unlicensed drug use, insecure and invalid drug use on children, to compare the discrepancy of cognition, attitude and factors within different groups, to explore the strategies of improving children’s participation as well as health providers’, to help health providers and parents get to know the clinical trials correctly, to make the process of clinical trials more specified, and to guarantee the authenticity of parents’ willingness by obtaining and analyzing the basic information of cognition, attitude and factors of health providers and parents.Methods: Qualitative research method is combined with quantity research method. Firstly, to know the study status in China and foreign countries and select related phrases by searching literatures; Secondly, to consult with the experts on how to better the questionnaires from GCP and ethic committee; Thirdly, to survey the health providers and parents in children’s hospital of Chongqing medical university; Fourthly, mean value, ratio, and constituent ratio are used to do the descriptive analysis, variance analysis is used to analyze data in different groups.Results: Cognition status of health providers and parents are similar. They both have a good knowledge of clinical trials’ importance, confidentiality, ethic committee; yet need to be improved in trials’ designs and recruitment advertisement. However, health providers in different groups differentiate cognition in trials’ design and operating details: health providers in GCP groups and doctors have a better understanding of trials’ designs than health providers in Non-GCP groups and nurses, while nurses and health providers with a willingness to be a primary investigator know better on operating details than doctors and health providers with a willingness to be investigators(P<0.05). Parents in different groups differentiate cognition in trials’ risks and human subjects’ rights. Parents with a willingness to be human subjects themselves or to allow their children to be human subjects know trials’ risks, informed consent, confidentiality better(P<0.05). Yet, because of lacking trials’ training and limited numbers of trials, titles and trainings of health providers have no effect their cognition. Parents’ willingness is getting lower as the education level and household incomes getting higher. Parents who have heard of clinical trials have a better cognition(P<0.05).Basically all health providers are willing to participate in clinical trials and have an obvious incentive of atrium and are mostly concerned with difficulties in process such as in recruitment, human subjects’ benefit, informed consent and so on. Parents with cautious willingness are mainly motivated by individual interests and concerned with trials’ risks and financial benefit. Among all the factors, household incomes, identification identity, trials’ type, trials’ cycle, visits and patients’ condition all have different influence on willingness.Conclusion: To help health providers and parents know clinical trials correctly, to resolve worries of both health providers and parents, to stimulate the heath development of children’s clinical trials, Firstly, it is needed to carry out national policies and hospital policies so as to create a good trials’ condition; Secondly, it is also necessary to reinforce GCP trainings by improving health providers’ cognition, establishing a high-level research team, standardizing the training courses and ensuring its quality, strictly screening the projects and developing the quality control, reviewing the projects rigorously and strengthening the communication with patients; Thirdly, improving the public cognition and relieve their fears through propaganda; Fourthly, to gain the public’s trust by strengthening the external supervision.