The multicenter prospective randomized clinical trial (RCT) is the keystone of clinical research. It is the research format that has the greatest possibility of causing a widespread change in clinical practice, with the change based on scientifically valid data. These studies attempt to avoid the biases of an individual site or investigator, generate larger numbers with an increase in the resultant statistical power, and provide more generalizable results.
However, despite decades of experience with RCTs, there are still significant challenges in their conception, planning, and execution. Collaboration must be obtained between proponents of the various modalities to be compared. These are frequently practitioners of different and sometimes competing medical specialties (eg, cardiac surgeons and cardiologists). Selection and staffing of participating sites must be accomplished. Finally, adequate numbers of willing research participants must be identified.
Machiedo GW. Network of Dedicated Enrollment SitesAn Attempt to Improve the Randomized Clinical Trial. JAMA Surg. 2014;149(6):513. doi:10.1001/jamasurg.2013.4172