Science has an interesting report on the publication of clinical trial results. Some readers will recall similar efforts from 2015 and 2017/2018 in the US and Europe; this is actually a follow-up by one of the same US authors. It should actually be a dull report, because the requirements for such disclosure are clear. The rules have been gradually tightened up over the years, most recently in 2017, and in January 2018 penalties went into effect for trials that are registered on Clinicaltrials.gov but whose results are not subsequently made public.
The article looks at 4700 trials what should have reported already under this law. It does seem to have improved disclosure rates, but it also seems as if there has been no enforcement whatsoever, so you wonder how long that improvement will last. We know that enforcement has been lax because there are many institutions that have had all sorts of difficulties fulfilling their obligations. That was the case in the earlier report, too, but it has to be said that some of the laggards in that one have picked up the pace. Sloan-Kettering, Duke, and Johns Hopkins did not look good in the 2017 figures, but have improved greatly. Who hasn’t? Obscure little outfits like M. D. Anderson, the Mayo Clinic, and UCSF have the great majority of their eligible trials marked as reported late or not reported, and there are plenty of others. The University of Virginia, for example has been involved in 23 trials that should have been reported, and the great majority of them haven’t even gotten as far as reporting late: they mostly haven’t shown up at all, showing an overall average of about nine months late and growing by the day. Yale has run 19 trials that should have reported during this period; only three have done so on time.
Even the federal government itself doesn’t come across looking very good. The National Institute of Allergy and Infectious Disease has reported over half its trials on time, but the rest of NIH hasn’t. Of those, National Heart, Lung, and Blood Institute is showing the lowest percentage of on-time reporting in the entire table, an impressive showing if you just ignore the minus sign in front of it. But if the NIH doesn’t bother to report its own work on time under the legal provisions of its own web site, it’s hard to see why anyone else should.
But do you know who does? The biopharma industry. The article’s charts are broken down by category (academia, government, and industry), and the absolute worst pharma company on the list is Teva. By a wide margin. But they would be one of the better ones on the other two lists. There are several companies with perfect records, and only one (Sanofi) that has a single trial that has not reported yet. Few non-industrial organizations even come close.
I should note that this was the same in the earlier looks at clinical trial reporting. For all the talk of drug companies burying trial results, industry actually seems to be taking its reporting responsibilities far more seriously than academia. Or the government itself. The new FDA commissioner used to be the chief medical officer at M. D. Anderson, the majority of whose 89 trials have reported late or not at all (averaging 128 days behind schedule). Is he the person who will bring things into line, do you think? Or will the agency just wag its finger a bit harder?