Can You Use Self Experimentation Data for FDA Approval of Products?(Thursday, September 3, 2020]​
Testing products on oneself to demonstrate their potential is as old as science itself. But self-experimentation maximizes concerns regarding the conflict of interest and bias in reported results making any reports anecdotal at best. So, can one use data from self-experiments to support formal additional clinical trials or even market approval? Self-experimentation is not illegal and may not even be unethical since the only person at risk is the person conducting the experiment on oneself. In fact, patients frequently self-experiment by taking medication at doses and dosing regimens different from the ones prescribed. Doctor’s also experiment on their patients by prescribing products off-label. There is no law requiring IND applications or IRB reviews for self-experimentation, rather all the regulations float around differentiating researchers and subjects. So, theoretically at least, a well-designed experiment with controls for bias could technically be used to create a rationale for one’s hypothesis which in turn can be used to support further clinical trials. FDA cannot outrightly reject data from any such experiment but can challenge the experimental design and results. One way to address FDA’s concern could be to prospectively design a self-experiment, demonstrate objective data collection, and complete disclosure of all data. That could be an impossible task as the experimenter is obviously biased in describing effects and risks. It is the proverbial circular logic; the experiment cannot be trusted completely because of the conflict of interest that goes beyond the classical definition of financial conflict and transcends belief and faith in one’s competence and integrity. There is a fringe group of patients and innovators who trust self-experimentation to be the answer to the financial conflict in industry developing treatment. But for all intents and purposes, the issues with self-experimentation far outpaces those from for-profit research and product development. Self-experimentation is inherently doomed to be at the fringes of the research community which is probably the best place for it.