Randomized controlled trials (RCTs) are the gold standard for clinical research, as the authors point out (1). Informed consent as well as consent to randomization are the ethical premises for most RCTs (2). Designs that completely eliminate informed consent are the low-risk pragmatic RCTs and the so-called prompted optional randomization trials (PORT).
A central problem in the ethics of clinical research is equipoise (3). Among other things, this dilemma explains why currently only 3–5% of potential patients are included in RCTs.
Interestingly, in the United States from 1973 to 2006, 68 anticancer drugs were approved by the FDA without evidence from RCTs. A further problem in oncology are negative studies as well as phase II or phase III studies that were discontinued or failed. Indeed, from 2013 to 2015, 32% of 5821 RCTs were discontinued or failed.
Footnotes
Conflict of interest statement
The author declares that no conflict of interest exists.
References
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