Current Status and Future Directions for Clinical Trials Pharmacy

Abstract

This survey was conducted to investigate the current status and suggest future directions for clinical trials pharmacy in Korea. A 32-item survey was distributed to 96 hospital pharmacies conducting clinical trials. The questionnaire was designed to elicit information on the following: (1) general clinical trial status of each hospital, (2) Investigational Drug Service (IDS) performance status. The response rate was 59.4％ and 61.8％ of the respondents carried out all the regulatory IDSs. Independent of the IDS's performance, the respondent started to feel the need for reinforcement in human resources when the number of active studies crossed 35. Analyzing the workload based on the subjective need for reinforcement in CTP, the overall CTP work execution rate was signiˆcantly higher in the`needs reinforcement' group (p＜ 0.05), even though this group had a 2.3 times higher workload than that in the`current number of CTPs is adequate' group. The`needs reinforcement' group performed more e‹ciently with a better understanding of IDSs, even though the group was having di‹culties due to the shortage of CTPs. The lower execution rate in the`current number of CTPs is adequate' group can be assumed to be due to the lack of understanding of the scope of IDSs. The work of CTPs should evolve into one of the specialized hospital pharmacists' roles, and a trial institution should designate at least one CTP per 40 protocols. Furthermore, the education for CTPs should be diversiˆed into basic course and advanced course based on the IDS's performance of each hospital.

Paediatric clinical research from the perspective of hospital pharmacists from France and Canada

“…In Korea in 2011, La et al . found that 0.8 FTE of pharmacists were assigned to clinical trial management (out of an average overall staffing of 21 pharmacists) . These authors deplored the insufficient number of pharmacists assigned to this sector as well as the lack of understanding of the pharmaceutical tasks performed by the rest of the members of the pharmacy department.…”

“…La et al . analyzed the main hurdles pharmacists face when assigned to clinical research and deplored the lack of expertise in clinical trial management . Wasserman et al .…”

Diretrizes para organização, funcionamento e avaliação de farmácias de ensaios clínicos no Brasil: revisão de escopo

“…Os equipamentos de proteção individual (EPI) deverão ser disponibilizados de acordo com as especificidades dos procedimentos reali- 56 x Cardoso, 2019 52 x Costa, 2018 49 x Hoagland, 2021 51 x Khandoobhai, 2017 47 x La, 2011 32 x Leite, 2017 25 x Littauer, 2017 50 x Mehta, 2015 20 x Santos, 2006 39 x Fonte: Autores.…”

“…Para o atendimento de portadores de doenças respiratórias, como tuberculose ou COVID-19, faz-se necessária a proteção biológica com o uso de respiradores 30,31 . Sistemas informatizados para inclusão ou randomização de participantes, dispensação de medicamentos, comunicação com a equipe e preenchimento de formulários são comumente utilizados em ensaios clínicos e devem ser considerados pela FEC 32 . Esses sistemas devem ter controles suficientes para impedir o acesso, mudanças não autorizadas e omissões de dados, além de sistema de recuperação de dados 33 .…”

Guidelines for organization, operation and evaluation of clinical trials pharmacies in Brazil: a scope review

“…For the preparation of injectables, gloves, safety masks, goggles, caps and lab coats are needed. For the care of patients x Cardoso, 2019 52 x Costa, 2018 49 x Hoagland, 2021 51 x Khandoobhai, 2017 47 x La, 2011 32 x Leite, 2017 25 x Littauer, 2017 50 x Mehta, 2015 20 x Santos, 2006 39 x Source: Authors.…”