Instituto de Evaluación de Tecnologías en Salud e Investigación-IETSI, EsSalud, Lima, Peru.
Universidad Privada del Norte, Trujillo, Peru.
Ther Innov Regul Sci. 2023 Jul;57(4):678-688. doi: 10.1007/s43441-023-00503-7. Epub 2023 Mar 28.
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.
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.
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.
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.
本研究旨在描述在 COVID-19 大流行期间对秘鲁社会保险医院进行临床试验（CT）检查的结果和虚拟检查的可行性。
本研究描述了 2021 年 8 月至 11 月期间进行的 25 项 CT 检查。变量数据来自社会保险监管和管理健康研究分部的 CT 检查数据库，其中包括会议记录和检查报告。我们使用相对和绝对频率描述所包括的 CT 的特征和检查结果。同样，我们通过自我管理问卷评估虚拟检查的可行性。
根据检查结果，60%的 CT 是关于生物制品的，60%的 CT 是关于传染病学的。此外，64%的 CT 是在利马进行的，52%是在四级卫生机构进行的，72%是由制药部门资助的。检查中主要发现是缺少提交要求的文件（16/25）以及缺乏互联网（9/15）和源文件（4/15）的访问权限。关于虚拟监督的可行性，大多数受访者对指导表的理解评为“正常”，内容评为“适当”。同样，在虚拟自我评估矩阵中，很大比例的受访者对理解评为“正常”（7/15），内容评为“适当”（13/15）。虚拟监督过程的质量评分为 8.6±1.1（1-10 分制）。
记录差异和未提交要求的文件是主要观察结果。大多数受访者认为材料是足够的，并对虚拟检查过程给予了总体良好的评价。
