After my mother, who designs preclinical studies for a living, did the research and found that preclinical research in animals looked promising, she took my doctor up on his offer to refer us. I was assigned to the group of patients that would receive the device (others were randomized to the standard surgery group, although my cardiologist noted that many of those assigned to surgery might choose to drop out of the trial).
As promised, the catheterization and device placement went smoothly, and I was out of the hospital in just a couple of days. In the months that followed, regular checkups and ultrasounds showed that the device was still working fine—it hadn’t moved out of place, and no pieces of metal had broken off and entered my bloodstream, both things that had been concerns in the animal trials.
After four years, my mother scheduled another checkup—but this time, doctors told her that the trial was over, and that I wouldn’t be having any more follow-up appointments. I haven’t had an ultrasound since, and to this day, I’ve never seen the results of the trial. The pediatrician who referred me retired shortly after I had my procedure, and my attempts to reach the doctor who ran the study have been unsuccessful, as have my requests to talk to someone on the hospital's media team. It’s more than a little unsettling to think that I’ll live for another 70 years or so with this device in my heart, but may never know what the research said about how it works.
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It often takes years for a drug or device to move from clinical trials to Food and Drug Administration approval. Even after the last patient has completed her last follow-up appointment, it still may take a couple more years to analyze the data and publish the results. If the data aren’t impressive, the study may never be published at all, meaning the public—and, more importantly, the trial participants—may never know the results.
In 1997, the same year that I had my procedure, Congress passed the Food and Drug Administration Modernization Act, which authorized the U.S. Department of Health and Human Services to develop a registry of clinical trials. The act, part of a growing movement to improve clinical-research transparency, required investigators and trial sponsors to register their trials before they began recruiting patients. Three years later, the National Institutes of Health made the registry, which lived at clinicaltrials.gov, available to the public—but while anyone could go online and look up the purpose of an investigational drug, or the locations where the trial was taking place, the site didn’t require the people registering the trials to include any information about the results.
In 2007, Congress passed the Food and Drug Administration Amendments Act (FDAAA). Among other things, the new law required investigators to publish summaries of their trial results on clinicaltrials.gov; the results database became public the following September. The law only applied to trials completed after December 2007, though, meaning my 1997 study was exempt.