The Reporting of A Disproportionality analysis for drUg Safety signal detection using spontaneously reported adverse events in Pharmacovigilance (READUS-PV) is an international collaborative which aim at developing the first reporting recommendations for studies using disproportionality analyses in databases of spontaneously reported adverse events. Our goal is therefore to enhance transparency by providing researchers with the minimum reporting…
The CANHEART ‘big data’ research initiative is aimed at measuring and improving cardiovascular health and the quality of ambulatory cardiovascular care provided in Ontario, Canada using the population-based CANHEART cohorts. The CANHEART cohorts were created through the linkage of 19+ routinely collected health administrative, vital statistics, survey and laboratory databases housed at ICES. The strength of these cohorts lies in the large sample size, containing information on 9.8 million Ontarians age 20-105 years, and diversity of the linked databases.
Building upon the insights gained to date through the CANHEART work, we have recently launched a new CANHEART SPOR project aimed at leveraging big data to conduct innovative cardiovascular clinical trials. We aim to: 1) undertake a pragmatic cluster randomized registry-based clinical trial to improve lipid-management amongst intermediate-and high-risk patients residing in high-risk health regions in Ontario (called CHOICES), and 2) develop novel algorithms for measuring clinical outcomes in clinical trials using health-related databases and compare whether they are as accurate as traditional event ascertainment methods in a prospective clinical trial (called INVESTED). These projects will be undertaken by an interdisciplinary team consisting of experts in administrative health databases, implementation science, clinical trials, knowledge translation and patient engagement.
Researcher Paula Byrne writes on what she and her colleagues learned from a meta-analysis of 21 clinical trials involving 140,000 patients.
Our study highlights that patients and doctors need to be supported to make decisions about treatments using evidence from all available studies and presented in a format that helps them understand potential benefits.