Skip to Content

Reporting Clinical Trials: Nothing Happens When Nothing Happens

A paper earlier this year detailed some pretty poor performance in reporting clinical trials, but the reporting on it was pretty poor as well. Reporters got tangled up in the data on trials that weren’t even legally obligated to report, missed the distinctions between industrial and academic trials, and more. Now the team at Stat has taken a more focused look at the problem. Clinicaltrials.gov has about 200,000 records, but 95% of those are not legally obligated to report data, as it turns out. Narrowing down on the 9,000 trials that are supposed to be reporting, though, provides some interesting figures.

Drug companies have long been castigated by lawmakers and advocacy groups for a lack of openness on research, and the investigation shows just how far individual firms have gone to skirt the disclosure law. But while the industry generally performed poorly, major medical schools, teaching hospitals, and nonprofit groups did worse overall — many of them far worse.

Indeed they did. The only two organizations in the entire set who complied with the legal obligations more than 50% of the time, as it happens, were big drug companies (Eli Lilly and AbbVie). At the other end of the scale, you have tiny, obscure outlets like Sloan-Kettering, who have a perfect record of being late on all 39 trials they’re listed for, with an average delay of 651 days. That figure also brings up another difference between the big drug companies on the list and the academic institutions – not on only are the former doing a (relatively) better job of reporting trial data, but they’re doing it with a much heavier workload as well, since they run many more trials.  Lilly, for example, is down for 139 trials in the database that are required to report, and GSK for 242.

To be sure, many of the drug companies may come out looking better because they’ve been more careful to file requests for extensions. But that’s more than most of the other institutions on the list have bothered to do. The article quotes Ben Goldacre as saying the “FDA and NIH penalties” might be necessary in order to get things enforced, but those two agencies would have to start by fining themselves. The article says that the FDA’s own staff scientists have violated the reporting laws 75% of the time, although compared to (say) Stanford, at a solid 95% noncompliance, perhaps that’s not so bad.

 

10 comments on “Reporting Clinical Trials: Nothing Happens When Nothing Happens”

  1. Old Timer says:

    From my own experience, compiling data for government reports falls pretty far down on the average academic’s to-do list.

  2. annon 2 says:

    As a reminder, GSK’s highest officer, Sir Andy Witty, has had a platform of complete openness including publishing all clinical data. Of course, that statement does not say anything about a time frame for posting, or even inclusion of apparently ongoing studies that deal with dead compounds. Yet one more inconsistent and hypocritical follow through by GSK’s management. (Why do people wonder why current and past employees of GSK are so cynical about the future of the group?)

  3. Rule (of 5) Breaker says:

    Laws with no consequences are not laws, merely requests.

    1. Weezl says:

      …until someone can make money by enforcing them. That’s why I’m more concerned about Goldacre’s comment than about overall non-compliance. Besides, I can’t think of a recent time when the government started policing itself. Insufficient opportunities for graft, and all.

  4. Wheels17 says:

    There’s a local cancer camp for kids that has been pushing a required reporting law, H.R.617 — 114th Congress (2015-2016) Clinical Trial Cancer Mission 2020 Act:

    http://www.cancermission2020.org/legislation

    “Amends the Public Health Service Act to revise clinical trial registry data bank provisions to specify that a device or drug clinical trial must be included in the clinical trial registry data bank regardless of whether it results in a positive or negative outcome.”

    Failure to report puts grant money at risk:

    “Makes a clinical trial grantee of the Department of Health and Human Services or DOD who fails to submit the required information to the data bank ineligible for the remaining grant funds or future funds. Makes the grantee liable for repayment of grant amounts already provided.”

    Full text at https://www.congress.gov/bill/114th-congress/house-bill/617/text

  5. Emjeff says:

    I suspect that much of this for the industry is not foot-dragging; rather it may be driven by the time it takes to write and publish these studies. Getting a rejection, and then re-vamping the paper can take a lot of time. Also, journals are not required to publish something just because it appeared on clintrials.gov.

    1. Anon says:

      “Also, journals are not required to publish something just because it appeared on clintrials.gov.”

      Journals that do not judge impact (eg, PLoS One) would address the quoted concern.

      1. Another anon says:

        This brings up a question in my mind: If you’re a pharmaceutical company, why bother trying to jump through the higher hoops of N. Engl. J. Med. or similar journals? Why not take the easy route and publish in journals like PLoS One that only look at scientific rigour? Your goals surely are only to (1) get positive results to progress along the path to approval, and (2) comply with legal requirements to publish the results.

        Granted if you have academic collaborators they may want to go for a higher impact journal.

  6. Biotechie says:

    Not clear how their sample of institutions and companies was limited. There looks like there are far fewer companies and institutions in their set than those undertaking clinical trials. Am I missing something?

Comments are closed.