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Academia (vs. Industry)

Reporting Clinical Trials

In 2015, a study looked at drug-industry sponsored clinical trials versus those funded by the NIH, and concluded that about 20% of industry trials did not report results when required to do so, while the figure for NIH-sponsored research was about 50% (and even more for trials funded by other institutions). At the time, I faulted a lot of the reporting on this issue, since an eye-catching figure of only 13% of pharma trials reporting kept coming up (without being corrected for the trials that were under no legal obligation to report at all during the period studied), and I particularly noted Ben Goldacre as someone who had failed to make that distinction.

Now we have similar figures for Europe, thanks to. . .Ben Goldacre, among others (commentary here at Nature). Regulations in the EU for reporting data within a year of trial completion have only been put in place recently as compared to the US (although, to be fair, they seem more straightforward in the EU), but this is a look at how that’s going. And it turns out that (of the trials that were required to report results) 32% of industry-sponsored trials have missed the deadline, while 89% of academic-run trials have failed to report. That latter figure is particularly bad, but it’s worth noting that both figures are worse than the US ones from 2015 (which may well have improved by this point). I’m glad to see that Goldacre is using numbers that are corrected for obliged-to-report trials this time, anyway. This paper does go into those details, which is good (but so did the 2015 one, and that didn’t stop its results from being misreported).

The take-home from both studies is that most clinical trials (in both the US and EU) are now obliged to report data within a year of finishing. Many trial sponsors seem to be having trouble making that deadline, and so far the problem seems to be worse in the EU. And on both sides of the Atlantic, it’s the drug-industry trials that have a far better compliance rate compared to the academic ones.

Here’s another interesting way of breaking down these numbers: if you look at the major sponsors (those with 50 or more trials to their names in the database), only 11 of them have a 100% reporting rate. All of those are from industry. Meanwhile, 32 of those big players have a flat zero per cent reporting rate, complete noncompliance. All of those are academic institutions. This is not a good look. The paper also notes “extensive omissions and contradictory data” in the EU registry entries, on top of the overall reporting issues. The hope is that since these requirements are relatively new that things will improve, but on the other hand, that will only happen if someone points it out and asks for better. Or, if that doesn’t work, if someone hammers on people a bit when they don’t improve. We’ll see if it gets to that point.

14 comments on “Reporting Clinical Trials”

  1. Austin says:

    I haven’t read the regulations, but can NIH/Euro funders put academic institutions on probation (with the consequence of no new funding if they don’t start reporting results)? Cause without that, there’s no accountability.

    1. Peter S. Shenkin says:

      Actually, there is accountability, and Goldacre has done the accounting. What there isn’t is enforcement, and perhaps enforceability.

  2. Sulphonamide says:

    Out of genuine curiosity, there appears to be considerable antipathy towards Goldacre, but is this justified (at a non-personal level)? I read his book Bad Pharma, felt suitably outraged, then – once my dampers had kicked in and I mentally subtracted 50% from everything he said – I set about trying to find out how he had manipulated or misrepresented the facts to suit his own agenda. However, there seems to be very little to be found that explains to the reader why more or less everything he said should not in fact be accepted as true. I would have expected at least a mildly-vitriolic backlash from those in the industry if he is simply spinning the facts to his own ends – but all that seems to be out there is pharma weakly dismissing his claims as being old-hat and something from the distant past. Doubtless I am missing something, but would very much appreciate if anyone can enlighten me as to what this may be.

    1. Calvin says:

      99% of the people who meet Ben in person are rubbed up the wrong way by him. Even in those institutions where is campaign is lauded, they don’t especially like dealing with him. He is fine when kept at arms length. So I think what you are picking up is that general antipathy of his personality rather than what he is trying to do.

    2. johnnyboy says:

      To me the problem with Goldacre is that he went from being an educator, and I think a fairly respected one (his first book “Bad Science” is quite an enjoyable read), to gradually becoming more of an anti-pharma militant/activist. When you do fairly neutral reporting of the issues, you can be taken as a reliable source of information. When you become a militant, you start twisting facts to fit your narrative; the ‘other side’ become wary of giving you credence by engaging with your arguments. That might be why you haven’t found that much public reaction to him – that, and maybe the general fatigue of pharma people towards the hordes of barn-burners out there.

      1. Stanislav Radl says:

        I have read both Bad Science and Bad Pharma since I was asked by a Czech journal to write a review on them. I must agree that the books are readable, but even in Bad Science the facts discussed are definitely biased. Especially parts dealing with Pharma, Nutrition and similar issues contain both evident errors and misinterpretations. And Bad Pharma, though also readable and even enjoyable, brought many interesting items but very often either distorted or erroneous.

  3. secret sauce says:

    Here’s additional sources on this troubling topic:

    BMJ, 2016, “Publication and reporting of clinical trial results: cross sectional analysis across academic medical centers” http://www.bmj.com/content/352/bmj.i637

    NPR, 2016, “Academic Medical Centers Get An F In Sharing Research Results”, http://www.npr.org/sections/health-shots/2016/02/23/467712481/academic-medical-centers-get-an-f-in-sharing-research-results

    NIH vidieocast, 2016, Mike Lauer, Deputy Director Extramural Research, “Evidence-Based Funding: A Funder’s Perspective” (@ 12:45 – 37:00) https://videocast.nih.gov/summary.asp?Live=18856&bhcp=1

  4. electrochemist says:

    I seriously doubt that anything will change on the academia side until continued NIH funding is linked to reporting results from previous studies. Lack of compliance = lack of $$$

    1. Scott says:

      That is probably the most effective ‘cattle prod’ in the toolbox. You’d need to carefully lawyer-proof the exact wording, however.

      I mean, someone doing their first clinical trial obviously has a 0% study reporting rate, because they have never reported. But that’s actually a divide-by-zero error, because they have never had anything to report before. So their study should be eligible for funding.

      But someone who has run dozens of clinical trials and hasn’t reported any should not get any more money for new trials until they report all their old data.

  5. Jon Berner says:

    You think the Obamacare website was a fiasco, try clinical trials.gov. What a waste of time. Poorly designed. If you are big Pharma it is no problem to enter all the data in because you have the bodies, the little guy is not so lucky.

    1. Spike says:

      Jon Berner – whilst I agree that the clinicaltrials.gov system is far from ideal, I would hardly call it onerous to complete the forms that need to be submitted. If that is a barrier to the small guy (and big academic institutes are bigger than most biotech companies) then I hate to think what their protocols and IBs look like.

  6. Spike says:

    In terms of enforceability, the FDA is now planning to move from the carrot to the stick. As BioCentury reported yesterday:
    In draft guidance released Thursday entitled “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank,” the agency said it plans to take a risk-based approach, prioritizing clinical trials “of public health importance,” as well as trial sponsors that have a history of previous non-compliance with reporting requirements. It will also assess civil monetary penalties for clinical trial reporting violations that are uncovered in conjunction with investigations of non-compliance with other statutory or regulatory requirements.
    FDA can levy penalties up to $10,000 for all violations adjudicated in a single proceeding, and up to $10,000 per day for violations that are not corrected within 30 days of the notification of a violation.

  7. anonymous says:

    I find myself at the top and bottom of this table in a way, at one of the bottom 50 institutions, but have performed analysis for trials in the top 50. One thing I’m aware of is it can take a long time for an individual to write up, it’s not unusual for the person running the study in academia to do so part time. I know of one author who eventually manged published the paper on a study several years after it completed (whether the EMA report had already been done I’m unsure, and it would have been before the 2016 compliance deadline), whereas industry teams presumably have at least somebody full time to move a report along.

  8. david becker says:

    Mr Lowe may be unaware but over $20 billion in fines for unreported or late reported clinical trials wasnt collected in the United States.
    To believe that trialists will spontaneously comply with new requirements is naive at best.
    It is clear government needs to be energetic in its efforts to enforcevregulations on trials and i have a hunch Mr Goldacre will agree with me.

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