Randomized Clinical Trials - Removing Unnecessary Obstacles

The authors, who are experienced clinical trialists, propose a framework for expediting the conduct of clinical trials and reducing what they perceive as unnecessary bureaucracy in current trial regulations. Since their widespread introduction in the middle of the 20th century, randomized trials of sufficiently large size have provided reliable assessments of the safety and efficacy of treatments that have produced substantial improvements in health.(1) During the past decade, however, increasingly onerous regulation and related bureaucracy have made trials much more difficult and costly to conduct, slowing further improvements.(2),(3) This adverse regulatory environment hinders important research and urgently needs to be changed for the benefit of patients and public health. As one example of the current problems (Table 1), the requirement to obtain approval from many different bodies before ...