ABSTRACT
Objective To investigate the satisfaction of clinicians on clinical research associates (CRA)and its influencing factors,for the purpose of providing rationalized proposals on education of CRAs.Methods 141 clinicians were randomly sampled from tertiary hospital for questionnaire survey,using the 5-point Likert scale.The survey covers 4 levels,i.e.,the work attitude,professional knowledge and ability,communication skills,and project management capabilities,as well as 14 dimensions.Data processing and statistics were analyzed using SPSS 15.0 software.The attribute characteristics of the investigation subjects were analyzed using x2 of the contingency table,along with analysis of its correlation with the general satisfaction on CRAs.Results The mean values of the 12 indicators range 2.28 to 3.75,with low satisfaction in general.Among these indicators,satisfaction of the service attitude of the CRA,and of their familiarity with the pilot program and CRF completion axe the highest,respectively,74.04％and 61.70％.Satisfaction of the rest 10 indicators falls below 50.00％.The chisquare analysis showed no association between satisfaction and gender,education,job titles.The satisfaction is different(P＜0.05)between those trained and those not,while there exists a significant differences(P＜0.01)between those participating in different number of tests.Conclusion Clinicians have a low satisfaction on CRAs.It is recommended to strengthen the training,establish a CRA occupation certification system,and to strengthen the clinicians' emphasis and competency of clinical trials.These actions will normalize the industry of clinical trials and improve the level of clinical trials in China.
ABSTRACT
Medical workers are the main designers and participants of clinical trials.In this consideration,popularization of good clinical practice (GCP)knowledge among them can improve their execution of trials,standardize basic clinical trial requirements,protect legitimate rights and health/safety of the subjects,and make the trial results more reliable.These objectives,if accomplished,will upgrade the clinical trials competency of medical institutions in China,and encourage healthy growth of the medical and pharmaceutical industry.The paper probed into the occupation qualification system of clinical trial workers and their supervision mechanism,inclusion of GCP into the continuing education system.
ABSTRACT
Small animal PET is a quantitative imaging technique that can noninvasive and dynamically image the distribution of positron-labeled radiopharmaceuticals in vivo,therefore representing a new means of providing information for drug development and evaluation.This article reviews the fundamental basis of PET imaging and their application in preclinical drug discovery and development.