TY - JOUR
T1 - Results and Feasibility of the Virtual Inspection of Clinical Trials During Pandemic of COVID-19 in Peru
AU - Herrera-Añazco, Percy
AU - Urrunaga-Pastor, Diego
AU - Soto-Ordoñez, Suly
AU - Torres, Fernando
AU - Dávila, Luis Manuel López
AU - del Carpio Toia, Agueda Muñoz
N1 - Publisher Copyright:
© 2023, The Author(s), under exclusive licence to The Drug Information Association, Inc.
PY - 2023/7
Y1 - 2023/7
N2 - Objective: This study aimed to describe the results of inspection of clinical trials (CTs) and the feasibility of conducting inspections virtually in Peruvian Social Security hospitals during the pandemic of COVID-19. Methods: This study described 25 CTs that were inspected during August 2021–November 2021. The data for the variables were obtained from the CT inspection database of the Social Security Sub-directorate of Regulation and Management of Health Research which includes minutes and inspection reports. We describe the characteristics of the CT included and findings during the inspections using relative and absolute frequencies. Likewise, we evaluated the feasibility of virtual inspection through a self-administered questionnaire. Results: According to the findings of the inspection, 60% of CTs were on biological products, and 60% were focused on infectiology. Additionally, 64% of CTs were implemented in Lima, 52% were conducted in level IV health facilities, and 72% were funded by the pharmaceutical sector. The lack of submission of requested documents (16/25) and inadequate access to the internet (9/15) and source documents (4/15) were the primary observations during the inspection. Regarding the feasibility of virtual supervisions, most interviewees rated their understanding of instruction form as “normal” and its content as “adequate.” Similarly, in the virtual self-assessment matrix, a large proportion of interviewees rated comprehension as “normal” (7/15) and its content as “adequate” (13/15). The quality of the virtual supervision process was 8.6 ± 1.1 on a scale of 1–10. Conclusion: Discrepancies in records and failure to submit requested documents were the main observations. Most interviewees considered the material to be adequate and gave an overall good rating to the virtual inspection process.
AB - Objective: This study aimed to describe the results of inspection of clinical trials (CTs) and the feasibility of conducting inspections virtually in Peruvian Social Security hospitals during the pandemic of COVID-19. Methods: This study described 25 CTs that were inspected during August 2021–November 2021. The data for the variables were obtained from the CT inspection database of the Social Security Sub-directorate of Regulation and Management of Health Research which includes minutes and inspection reports. We describe the characteristics of the CT included and findings during the inspections using relative and absolute frequencies. Likewise, we evaluated the feasibility of virtual inspection through a self-administered questionnaire. Results: According to the findings of the inspection, 60% of CTs were on biological products, and 60% were focused on infectiology. Additionally, 64% of CTs were implemented in Lima, 52% were conducted in level IV health facilities, and 72% were funded by the pharmaceutical sector. The lack of submission of requested documents (16/25) and inadequate access to the internet (9/15) and source documents (4/15) were the primary observations during the inspection. Regarding the feasibility of virtual supervisions, most interviewees rated their understanding of instruction form as “normal” and its content as “adequate.” Similarly, in the virtual self-assessment matrix, a large proportion of interviewees rated comprehension as “normal” (7/15) and its content as “adequate” (13/15). The quality of the virtual supervision process was 8.6 ± 1.1 on a scale of 1–10. Conclusion: Discrepancies in records and failure to submit requested documents were the main observations. Most interviewees considered the material to be adequate and gave an overall good rating to the virtual inspection process.
KW - COVID-19 pandemic
KW - Clinical Trial
KW - Social Security (source: DeCS BIREME)
KW - Virtual Supervisions
UR - http://www.scopus.com/inward/record.url?scp=85151124054&partnerID=8YFLogxK
U2 - 10.1007/s43441-023-00503-7
DO - 10.1007/s43441-023-00503-7
M3 - Article
C2 - 36976455
AN - SCOPUS:85151124054
SN - 2168-4790
VL - 57
SP - 678
EP - 688
JO - Therapeutic Innovation and Regulatory Science
JF - Therapeutic Innovation and Regulatory Science
IS - 4
ER -