Recent National Academy of Medicine report suggests Expanding the Role of N-of-1 Trials in the Precision Medicine Era: Action Priorities and Practical Considerations
While their is some intuitive appeal to the most highly tailored personalized care being best... the notion that this constitutes research or can be extrapolated to others is highly suspect. This is more akin to trial and error with no means to establish a causal link between treatment and outcome
below are the conditions thought to be requisite to engage in N of 1 research
Conditions necessary for N of 1 trials
Chronic stable slowly progressive condition frequently relapsing and not emergent or imminently life threatening
No established standard effective treatment, rapid therapeutic effect, ability to try multiple different interventions safely and sequentially
Objective established measure of effectiveness
Willingness to participate after obtaining full informed consent
Warning bells should be sounding!!
The above criteria are so restrictive in nature that virtually no condition or patient would qualify. The suggestion that N of 1, is research, creates the illusion of science while in essence we are creating individual guinea pigs exposed to significant risk with virtually no benefit to be realized other than by pure luck.
Personalized medicine has been dramatically oversold as a solution to “your” health needs and while very useful to establish effectiveness of certain tumors to individualized chemotherapeutic agents, is still in its infancy.
Cost has also never been factored into the impact of personalized medicine which could be prodigious
We need to proceed cautiously with deliberate, informed, slow and prudent course of action or risk breaking through the ice and being much worse off.