In order for a new medication to obtain FDA approval for human consumption, the drug under consideration must ultimately undergo intensive evaluation in humans. There are rules and ethical principals that have been established to govern the appropriate conduct of clinical trials. These rules are intended to insure the safety of the people who elect to participate in such trials, as well as to insure the integrity of the scientific process.
To this end, the National Institutes of Health (NIH) has published seven principles to guide the conduct of research trials,and investigators are well advised to consider the importance of each as they launch into any clinical research investigation (https://www.nih.gov/health-information/nih-clinical-research-trials-you/guiding-principles-ethical-research).
• Social and clinical value
• Scientific validity
• Fair subject selection
• Favorable risk-benefit ratio
• Independent review
• Respect for potential and enrolled subjects
The ethical principles underlying the conduct of clinical research trials may be particularly relevant when attempting to enroll volunteers of diminished capacity, such as might occur when enrolling patients into memory loss studies. In such cases, great care must be exercised in order to insure that potential participants (and their caregivers) understand the potential risks and benefits associated with participating in a clinical research study, as well as their rights as a participant in such a study. The likelihood of actually receiving the active medication, as opposed to the inactive (placebo) medication must also be clearly explained. To this end, many clinical trials have taken to making the probability of receiving the active medication greater than that for receiving the placebo. This last point is particularly important with respect to those suffering from Alzheimer’s Disease, as the underlying deterioration of the brain is progressive, and there is only a small window within which a treatment may actually be able to affect any possible benefit.