We wrote a little over a month ago about the large number of institutions not reporting study results, as required on ClinicalTrials.gov. Now, Stat reports that a federal court has ruled that those reports must be filed, although the timeframe for compliance remains ambiguous.
Despite the good news for those interested in transparency in science and regulatory policymaking, there remains a bias in how the story is told.
“This decision brings us one step closer to what federal law requires — providing the American public with complete access to clinical trial results on drugs and medical devices approved by the FDA,” said Christopher Morten, a supervising attorney at New York University’s Law & Policy Clinic who represented the plaintiffs. The ruling, he said, “makes it harder for drug companies, device manufacturers, and other trial sponsors to keep unfavorable trial results secret.” Emphasis added.
Who are those other trial sponsors? You can refer back to what I wrote, but I will save you time. They are academic medical centers. Their compliance is the worst of the three, and they were not mentioned. Far better to drag out the standard villains, Big Pharma and Big Device. To be fair, this is not the voice of Stat, which has called out the university consortiums on this problem. It is the voice of the universities, and you have to wonder how blind they are to their behavior. I am reminded of Step 5 and 9 in everyone’s twelve-step program; admit the exact nature of our wrongs, and make direct amends.