Back to the future: the urgent need to re-introduce streamlined trials

The increasing over-regulation of randomized controlled trials during the past 20-30 years has caused increased obstacles, delays and costs. A direct consequence is fewer new treatments being developed by industry, and fewer academic trials being conducted of current therapies, slowing improvements in patient care. There is an urgent need to bring together all those with an interest in the reliable evaluation of treatment safety and efficacy in order to develop guidance based on the underlying scientific principles that is appropriate for randomized trials in the 21st century.