Clinical Trial in Hospital Practice: Pharmacists Perspective and Risk Management Reflections
Author(s)
De Fina Mariarosanna , Zito Maria Cristina , Naturale Maria Diana , Esposito Stefania , De Francesco Adele Emanuela ,
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Abstract
In recent years the number of clinical trials has undergone a significant increase worldwide. In Europe the law n. UE 536/2014 represents an important turning point in the field of clinical trials of medicines. In an Italian national context characterized by profound revolutions and innovations, the hospital pharmacist plays an important role in the management of the protection of the human person, in terms of the rights, safety, dignity and well-being of the subjects enrolled in clinical trials.
Objects of work: Evaluate the clinical trials conducted and the complexity of management from the hospital pharmacist's perspective and analyse the complexity of the trials conducted.
Retrospective study was carried out at Mater Domini University Hospital in Catanzaro (Italy) during 01/01/2017- 31/12/2019. The delivery to the hospital pharmacy was recorded as index data. All clinical trials started in study period were included. In order to estimate the complexity of management, a questionnaire was developed and administrated to all authors involved to clinical trial management. The questionnaires results were calculated as average scores for individual items. The scale comprises 10 close ended, pretested, highly reliable questions. The complexity score of the trial was evaluated with Cronbach’s alfa test and Pearson correlation. In total, 94 clinical trials were started from 2017 to 2019, including 15 Therapeutic Area and 25 different Principal Investigator. In totally the Cronbach’s alfa for our complexity scale is 0.807. The Pearson correlation is particularly significant (p<0.001) for questions related to management and risk management.In conclusion, this study provided a broad representation regarding the pharmacist's perception on role on the services provided. The pharmacist involved into clinical research study is essential for maintaining the highest standards for medication safety practices and ultimately, the quality, efficacy, and safety.
Keywords
Clinical Trial, Research Pharmacist, Clinical risk management, Hospital Pharmacist, Cronbach’s alfa Pharmacy Management.
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