García-Mostajo Jorge A, Rivera Fulton P, Alvarez-Arroyo Violeta, Catacora-Villasante Manuel, Acosta Joshi
Instituto de Evaluación de Tecnologías en Salud e Investigación - IETSI, EsSalud. Lima, Perú.
Universidad Científica del Sur. Lima, Perú.
Rev Peru Med Exp Salud Publica. 2019 Oct-Dec;36(4):687-691. doi: 10.17843/rpmesp.2019.364.4569. Epub 2020 Jan 17.
The objective of the study was to describe the characteristics of the Clinical Trials (CT) supervised by the Institute of Health Technology Assessment and Research carried out in EsSalud between 2015 and 2018 and the main observations of the supervisions completed. A descriptive study of 82 supervised clinical trials was conducted between 2015 and 2018. Most of the clinical trials were phase III studies (81.7%); the most frequent route of administration of the study products was oral (47.6%), and most were sponsored by the pharmaceutical industry (96.3%). The most frequent observations were those related to the study contract (83.8%), overhead payment (57.3%), and the lack of regulatory documents (47.6%). These findings allow the identification of opportunities for improvement in research regulation and management.
该研究的目的是描述2015年至2018年期间在EsSalud开展的、由健康技术评估与研究机构监督的临床试验（CT）的特征，以及已完成监督的主要观察结果。2015年至2018年期间对82项受监督的临床试验进行了描述性研究。大多数临床试验为III期研究（81.7%）；研究产品最常见的给药途径是口服（47.6%），且大多数由制药行业赞助（96.3%）。最常见的观察结果是与研究合同相关的（83.8%）、间接费用支付（57.3%）以及缺乏监管文件（47.6%）。这些发现有助于确定研究监管和管理方面的改进机会。
