Grant: Operating Grant: SPOR Innovative Clinical Trial Multi-Year Grant

Traditional randomized clinical trials (RCTs) have provided extremely valuable information on medical therapies (e.g., statins) and procedures that have changed the way cardiovascular diseases are treated. However, despite their contributions, traditional RCTs are costly, their findings may not be applicable to patients unlike those in the study, and the use of trial findings may be infrequent. These limitations may be addressed by the field of 'big data.' Novel and efficient methods can be developed using big data to conduct clinical trials by facilitating recruitment of patients, measuring patient characteristics and follow-up of patient outcomes in large 'real-world' populations. While Canada has some of the world's best population-based health databases, much work remains to be done to determine how best to use these data in clinical trials. Our multi-disciplinary team of 30+ researchers, health care professionals, decision makers and patients will undertake two studies which will test the potential of using big data to: a) increase use of cholesterol-lowering statin drugs aimed at preventing heart attacks and strokes, and b) accurately identify the occurrence of cardiovascular hospitalizations in clinical trials. By leveraging big data, this project has the potential to transform how clinical trials are conducted and dramatically lower costs, making Canada a world leader in innovative clinical trial methodologies and attracting more clinical research to this country.