When it comes to finding the right therapeutic dose of reta, there appears to be a great deal of variation, and no clear demographic factor stands out that would allow dosing to be standardized. Because of this, clinical trials will have shortcomings if every participant enrolled in a study receives an identical dose. Should the dose response to Reta turn out to be highly individualized, a bell curve would end up containing many "outliers."
Take a hypothetical case: suppose a trial enrolls a sample of 1000 female adults who are new GLP users, all with a BMI of 30, and none of them have other chronic conditions or confounding factors. Each of them receives 3 mg Reta on Mondays, Wednesdays, and Fridays (9 mg Q W). If the proper Reta dosage is "widely individualized," which is what I suspect, then a substantial share of the trial participants would experience severe side effects, since for them the dose was too high. At the same time, a substantial share of participants would have gained more benefit from a higher dose, since for them the dose was too low. A bell curve would show many outliers at both extremes.
As a general rule, the medical profession, regulators, and pharmaceutical companies are not fond of "wide individualization" when it comes to prescribing. On top of that, researchers struggle to design quantifiable trials when participants choose a dose based on an individualized "feel" of what is correct, because measuring outcomes becomes less quantifiable. If "widely individualized" dose correctness does exist, approval could be delayed.
