When a supplement company wants to validate its ingredients, a necessary step is conducting a clinical trial. As Jay Udani, M.D., CPI, CEO and medical director, Medicus Research LLC, explained in his talk at SupplySide West this afternoon, every stepfrom background research to choosing a study method and interpreting resulttakes careful consideration. However, the biggest revelations to me was with choosing the study population.
I thought that its important choose subjects without diseases because FDA doesnt allow disease claims for supplements, but thats not exactly true. Udani noted its difficult to find truly healthy" patients. For researchers purposes, he said its just best to make sure the patients in the study dont have the diseases under investigation. For instance, if a company is researching a probiotic for digestion, patients can have high blood pressure, bad joints or poor eyesight, and still be considered healthy" in this study of gut health.
I was also suprised that conducting a supplement study on diseased patients may not only be unfruitful from a claims point, it may be illegal. Thats at least according to FDAs investigational new drug (IND) draft guidance that was released in 2010. That draft guidance, which Udani said is expected to finalized soon, says any ingredient used in a clinical trial of diseased patients needs to have an IND notification submitted to FDA.
Therefore, Udani said the best patients to study for a supplement are those who are at risk for diseases, which he said are actually easier to find than diseased patients. He said patients often need to fulfill a strict set of criteria to be diagnosed with a disease. Those considered at risk" dont need to meet all of the same standards.
Find more information on designing studies in INSIDERs Lab Insights Content Library.