Large Simple Trials and Knowledge Generation in a Learning Health System – Workshop Summary

IOM: September 24, 2013

Despite a robust clinical research enterprise, a gap exists between the evidence needed to support care decisions and the evidence available. Streamlined approaches to clinical research provide options for progress on these challenges. Large simple trials (LSTs), for example, generally have simple randomization, broad eligibility criteria, enough participants to distinguish small to moderate effects, focus on outcomes important to patient care, and use simplified approaches to data collection. Significant opportunities, including the wide-spread adoption of electronic health records, could accelerate the potential for the use of LSTs to efficiently generate practical evidence for medical decision making and product development. Read more