Intensive Monitoring Studies for Assessing Medicines: A Systematic Review.

摘要: Introduction: Intensive monitoring (IM) is one of the methods post-marketing active surveillance based upon event monitoring, which has received interest in current medicines regulatory landscape. For a specific period time, IM involves primary data collection and actively focused on gathering longitudinal information, mainly safety, since first day drug use. Objectives: To describe systems studies' published over 11-years (2006-2016). Specifically, we reviewed study population/event surveillance, methodological approaches, limitations, its applications real-world evidence generation data. Methods: We completed systematic search MEDLINE EMBASE to identify studies from 2006 2016, that used methodology. extracted using standardized form results were analyzed descriptively. The quality selected was assessed modified Downs Black checklist. Results: From 1,400 screened citations, identified 86 papers, corresponding 69 different studies. Seventy percent corresponded established systems, which, more than half prescription (PEM) modified-PEM. Among non-established vaccines most common studied drugs (n = 14). median cohort size ranged 488 (hospitals) 10,479 patients. Patients caregivers source 39.1% mean overall score similar between IM. Conclusions: Over period, implemented 26 countries with maturity levels systems. two major limitations: only 20% conducted at hospital-level, matter concern, insofar as healthcare are facing lack access new ambulatory care level. Additionally, exposure cohorts, either identification or follow-up stages, could somehow constitute barrier, given complexity managerial, linkable, privacy issues.