The good, the bad and the ugly red tape of biomedical research. How could regulators lower bureaucratic hurdles in clinical research without compromising the safety of patients?

Biomedical scientists have long felt the tension between their desire to perform innovative clinical research and the bureaucratic red tape that aims to protect patients. For years, scientists have been complaining about the rules and regulations that can hold up the progression of their biomedical research from the bench to the bedside. A recent study has once again highlighted this problem (ContopoulosIoannidis et al, 2008). The authors examined 32 scientific papers describing effective medical interventions, each with more than 1,000 citations, which, they argue, suggests that the publications represent ‘scientific milestones’. Within the scope of the study, the average ‘translational lag’—the time between a discovery and the first highly cited study showing its clinical usefulness—was 16.5 years, with a range of 0–221 years.