An analysis published July 19 in Regenerative Medicine reminds us to be cautious about believing everything we read regarding clinical trials. A good case in point is our earlier report about three women who were blinded by an unproven stem cell treatment at a Florida clinic in 2015. They had been misled primarily by thinking that simply calling something a clinical trial does not necessarily guarantee the safety and efficacy of the treatment protocols offered.
A legitimate clinical trial follows rigorous protocols under FDA guidelines. It usually takes place in several phases at several centers under approved clinicians, with results carefully analyzed at each step before permission is given by the FDA to move on to the next phase. It will also usually concentrate on one treatment for only one particular condition, in order to eliminate any variables that could affect the results. Finally, participants should not be asked to pay out-of-pocket for any treatment directly related to the trial.
Clinical trials are announced and described at clinicaltrials.gov and centerwatch.com. These sites, however, do not guarantee the legitimacy of their listings, so patients must be diligent in vetting the companies and their intentions. If it appears to be a marketing ploy, and it doesn’t fit the above criteria, ask a professional for advice.