Process Management In Phaseâ… Clinical Trial Ward Management

PurposeThrough application of process management approaches in phase I clinical trialward standardized management, investigate quality control methods in phase I clinicaltrial ward management, ensure the quality of phase I clinical trials, analyze the currentsituation of phase I clinical trials ward, develop phase I clinical trial ward processmanagement modes and methods, provide evidence to guide phase I clinical trial wardmanagement, provide guidance for clinical care process quality for managers andnurses, and control phase I clinical trial ward quality.MethodsFrom January2012to December2013,80cases of ward nurses and48cases ofclinical drug subjects were selected from3provincial hospitals. Based on a randomnumber table, subjects were divided into observation group(40nurses,24subjects) andcontrol group(40nurses,24subjects). The control group applied routine wardmanagement, and observation group applied process management(including phase Iclinical trial ward management content and criteria, and phase I clinical trial wardnurses were trained to establish quality control consciousness). The quality of wardnursing management was tracked and measured. SPSS statistical software was usedfor data analysis.Results1. Compared to conventional care, process management approaches can statistically improve service awareness, sense of responsibility, problem solving skills, specialistknowledge, learning ability, specialist operational capability, and documentmanagement skills for nurses in phase I clinical trial ward (P <0.05).2. Compared to control group, observation group showed a higher rate of compliance,lower rate of expulsion rate, and the differences were statistically significant(P<0.05).3. Compared to observation group, patients in control group showed statistically moremedication inconvenient, traffic inconvenience, suspicion to clinical trials, failure tocomplete the required diary cards, and poorer medication efficacy(P <0.05).4. In observation group,12cases were great satisfied,8cases were satisfied,2caseswere generally satisfied,2cases were not satisfied; in control group,3cases weregreat satisfied,8cases were satisfied,10cases were generally satisfied,2cases werenot satisfied,1cases were extremely unsatisfied. The satisfaction rates betweengroups were statistically significant(P<0.05).5. In observation group, a total of5cases of subjects observed adverse event,including2cases with mild adverse effect,3with moderate adverse effect, and nosevere adverse effect was observed; in control group,7cases of adverse eventoccurred, including2cases with mild adverse effect,3with moderate adverse effect,and2cases with severe adverse effect. Subjects in both groups were getting betterafter treatment, and no deaths or serious complications occurred.6. The incidence of repeated puncture, failure to take medicine, writing mistakes,compliance with the wrong prescription was significantly lower in observation groupcompared to control group(P<0.05).7. After process management, knowledge of GCP, SOP and first aid skills in nurseswas significantly higher in observation group compared to control group(P<0.05).Conclusion1. Process management may effectively improve the risk management awareness ofnurses and improve the quality of nursing care.2. Process management may effectively improve the satisfaction and compliance of subjects in phase I clinical trials and reduce the expulsion rate of subjects.3. Process management may effectively reduce the incidence of adverse events duringphase I clinical trials.