Authors (including presenting author) :
Chan THY(1), Mak RWM(1), Wong VKC(1), Chui WCM(1)
Affiliation :
(1) Department of Pharmacy, Queen Mary Hospital, Hong Kong
Introduction :
The Clinical Trials Pharmacy (CTP) in Queen Mary Hospital (QMH) is a National Medical Products Administration (NMPA)-accredited pharmacy for providing professional management of investigational products. The COVID-19 pandemic has led to the implementation of different degree of public health and social measures, which has in turn affected the conducting of clinical trials worldwide.
Objectives :
(1) To report the trend of clinical trials managed by QMH CTP; (2) To understand the magnitude of impact of COVID-19 on clinical trials in QMH and (3) To propose strategies that could be adopted to facilitate clinical trials during COVID-19 or in the long run.
Methodology :
The workload statistics in QMH CTP were analyzed. A questionnaire was sent to investigators, Research Assistants (RAs), Clinical Research Associates (CRAs) and their managers to collect feedback on the impact of COVID-19 on conducting trials and the possible strategies that would be useful in facilitating clinical trials during COVID-19.
Result & Outcome :
The number of active trials was 178 in November 2022, which was a 128% increase compared to that in 2012 (78 trials). The total number of dispensing activities were increasing and remained stable in 2022 (+23.5% in 2018, +54.1% in 2019, +12.1% in 2020, +1.6% in 2021, -0.1% in 2022). 23% respondents (N=121) reported that there was clinical trial suspended due to COVID-19. Around 80% respondents believed that COVID-19 had a negative impact on performing study visits as scheduled (81.8%), patient recruitment (78.5%) and conducting on-site monitoring visits by CRAs (79.1%). Remote monitoring visits by CRAs (71.1%), study drug delivery to home with telepharmacy service (61.2%), tele-consultation (58.7%) and virtual site visits (51.2%) were some of the strategies that could facilitate trials during COVID-19 as suggested by the respondents. There were negative impacts observed in conducting clinical trials during COVID-19. Strategies such as the use of remote monitoring and telehealth services with drug delivery to patients may be adopted during COVID-19 or in the future in order to minimize hospital/clinic visits and inconveniences caused to patients while maintaining the ethical standards and quality of clinical trials.
