Some American companies and institutions will simply refuse to make their clinical trial results public as required by federal law unless the U.S. Food and Drug Administration imposes fines on them, new data suggest.
While such a move would be an incredibly welcome move and good use of existing governance mechanisms, it is worth noting the U already has a law on the books that requires the publication of clinical trials results. The fact the US has 3,000 missing clinical trial results is completely unacceptable. The situation is inefficient, disrespectful and potentially dangerous. Offenders should always be fined, penalised and publicly called out. We have included links to 14 related items.
‘Medical aesthetics’ company Cutera appears unwilling to disclose efficacy and safety data from clinical trials of the medical devices it sells – unless and until the FDA forces it to put its cards on the table. TranspariMED has over the past two years repeatedly exhorted the company to come clean about its 16 overdue clinical trial results, and upload them onto ClinicalTrials.gov as required by law. Countless emails, Tweets, and blogs later, Cutera has still not made a single result public on the registry, making it America’s worst performer in relative terms.
CASE STUDY TWO: UNIVERSITY OF VIRGINIA
The University of Virginia currently owes its patients and the public the results of 28 clinical trials in violation of the law, making it by far the most profligate law-breaker among American medical research institutions. In early November last year, TranspariMED reached out to the university, pointed out the missing results, and encouraged it to fix the problem. Ten weeks later, the university has still not improved its performance. It is still the country’s worst performer in absolute terms.
The National Institutes of Health have the power to cut off future grant funding to the university over its legal violations, as Deborah Zarin, the former administrator of the ClinicalTrials.gov registry, pointed out on Twitter: