Results and Feasibility of the Virtual Inspection of Clinical Trials During Pandemic of COVID-19 in Peru
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2023-03-28Autor(es)
Herrera Añazco, Percy
Urrunaga Pastor, Diego
Soto Ordoñez, Suly
Torres, Fernando
López Dávila, Luis Manuel
Muñoz Del Carpio Toia, Agueda
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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
fndings 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 fndings 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. Mo
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Cita bibliográfica
Herrera, P., Urrunaga, D., Soto, S., Torres, F., López, L. M., & Muñoz, A. (2023). Results and Feasibility of the Virtual Inspection of Clinical Trials During Pandemic of COVID-19 in Peru. Therapeutic Innovation and Regulatory Science, 57(4), 678-688. https://doi.org/10.1007/s43441-023-00503-7
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