Results and Feasibility of the Virtual Inspection of Clinical Trials During Pandemic of COVID-19 in Peru.

Autor: Herrera-Añazco P; Instituto de Evaluación de Tecnologías en Salud e Investigación-IETSI, EsSalud, Lima, Peru. Silamud@gmail.com.; Universidad Privada del Norte, Trujillo, Peru. Silamud@gmail.com., Urrunaga-Pastor D; Instituto de Evaluación de Tecnologías en Salud e Investigación-IETSI, EsSalud, Lima, Peru.; Unidad para la Generación y Síntesis de Evidencias en Salud, Universidad San Ignacio de Loyola (USIL), Lima, Peru., Soto-Ordoñez S; Instituto de Evaluación de Tecnologías en Salud e Investigación-IETSI, EsSalud, Lima, Peru., Torres F; Pedro de Elizalde General Children's Hospital, Buenos Aires, Argentina., Dávila LML; Department of Medical Sciences, Centro de Investigaciones de las Ciencias de la Salud-CICS, Member of the Bioethics Committee in Health Research USAC, Universidad de San Carlos de Guatemala-USAC, Guatemala, Guatemala., Del Carpio Toia AM; Escuela de Postgrado, Escuela de Medicina Humana, Vicerrectorado de Investigación Universidad Católica de Santa María, Arequipa, Peru.; Instituto de Ética Clínica Francisco Vallés, Madrid, Spain.
Jazyk: angličtina
Zdroj: Therapeutic innovation & regulatory science [Ther Innov Regul Sci] 2023 Jul; Vol. 57 (4), pp. 678-688. Date of Electronic Publication: 2023 Mar 28.
DOI: 10.1007/s43441-023-00503-7
Abstrakt: 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.
(© 2023. The Author(s), under exclusive licence to The Drug Information Association, Inc.)
Databáze: MEDLINE
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