Grant: Knowledge Synthesis Grant - PA: Drug Safety and Effectiveness Network

Traditional randomized controlled trials (RCTs) randomly allocate research participants to one intervention from a set of at least two, where the interventions are implemented in parallel over time, and may include a placebo. In all such trials, data is collected prospectively from consenting individuals, and often include one or more interviews with each participant. Although the gold standard for interventional studies because they tend to be the most accurate, the usual method of doing RCTs is labour-intensive and costly. Increasing the efficiency of labour intensive randomized trials while maintaining or improving methodological rigour is important to both research funding agencies and researchers. Although there are multiple potential alternatives to traditional randomized trials, researchers tend to be unaware of these alternative designs, and learning about them is difficult because this information is not available from a single source. Perhaps as a result, such alternative methods appear to be infrequently used by researchers - and so closing this knowledge gap has the potential to substantially influence the number of interventional studies that Canadian researchers successfully complete. The current proposal describes a comprehensive systematic review of the literature and a survey that will describe the legal, ethical, and cultural barriers and facilitators associated with each alternative design. The key final product will be an inventory of appealing alternative designs where we summarize the advantages and disadvantages of available alternatives to the traditional randomized trial.