In the United States, companies and universities running clinical trials are legally required to make their results public - but some still fail to do so.
Many of the largest pharmaceutical companies and prominent academic institutions running clinical trials are now following the law.
The most prolific trial sponsors with a 100% disclosure rate are:
Novartis (103 trial results reported)
Mayo Clinic (88 trials)
Gilead (73 trials)
Pfizer (70 trials)
GlaxoSmithKline (70 trials)
America's most prolific sponsor of clinical trials overall, M.D. Anderson Cancer Center, closely misses the mark with a 99% reporting rate - a strong improvement on past years.
The second largest sponsor by volume, the National Cancer Institute, has also significantly improved. However, its current reporting rate of 90% is still far from perfect.
Using the FDAAA Trials Tracker, TranspariMED has identified the worst violators of the law:
Each of the American trial sponsors listed below has run ten or more trials whose results should have been disclosed on the public ClinicalTrials.gov database
Each of the sponsors has uploaded fewer than half of the required results
The worst offender is the company Cutera, which has not made a single clinical trial result public.
Runner-ups for the title of least transparent sponsor are Henry Ford Health System, which has only made 6% of due trial results public, and the University of Arizona, which has a disclosure rate of only 18%.
The chart below shows the percentage of due trials for which results have been made public.
By now, the Food and Drug Administration (FDA) could have collected over $65 million in fines from Cutera alone for its legal violations.
The results of 16 clinical trials run by the company are currently missing from ClinicalTrials.gov. Click on the image below to see the full list of Cutera’s unreported clinical trials.
To date, the FDA has failed to impose a single fine, despite repeated calls by medical experts, doctors and patients for it to finally enforce the law.
As of September 2020, over 2,000 trial results are missing from the public database.
Due to the well-documented dangers that hidden medical evidence poses to patients and public health, regulators in other countries have recently taken strong steps to ensure that clinical trial reports are made public.
In Denmark, sponsors that keep clinical trial results hidden already risk getting sent to jail
The UK is planning to introduce sanctions in the near future
Making the results of drug trials public will become a legally binding requirement across the European Union once the EU Clinical Trial Regulation comes into force (probably late 2021)
Note on methodology:
Data were extracted manually from the FDAAA Trials Tracker on 24 and 28 September 2020. Like the Tracker itself, the blog and data above only take into account clinical trials that are, or appear to be, subject to, FDAAA disclosure requirements (ACTs and pACTs) in the wake of the FDAAA Final Rule. Trials not subject to FDAAA disclosure requirements are not included in this analysis.
TranspariMED counted trials as compliant with the law if their results were available on ClinicalTrials.gov, even if those results had only been uploaded after the 12 month deadline set by the law had passed. While this approach is arguably too lenient, it avoids penalising sponsors that have successfully tackled the problem for their possibly suboptimal performance in preceding years. Readers can identify which results were reported late by browsing each sponsor's portfolio on the Tracker.
The Tracker itself was designed and is maintained by the CEBM team at Oxford University. Details on the Tracker’s methodology are available online. CEBM was not involved in data extraction or the writing of this blog.