Randomized controlled trials (RCTs) have been a staple of the drug development process for several decades. Here, we review the origins of RCTs and their adoption within drug development, highlighting shortcomings that tend to be ignored and possible solutions offered from personalized medicine. While RCTs play an important role in development of therapeutics, we underscore how if used indiscriminately, their adverse effects may outweigh the benefits. As an example, we focus on the development of antidepressants and how a severe adverse drug response – suicidal ideation – can be overlooked. We conclude with a discussion of how pharmacogenetics may address some of the deficiencies of RCTs, bringing the focus of drug response back to the individual patient rather than the population, using as an example the discovery of genetic markers associated with antidepressant-induced suicidal ideation.
Personalized Medicine. 2014;11(1):79-88. © 2014 Future Medicine Ltd.