“The medical press must become irrelevant to publication of clinical trials.”

pmed0020138g001“The medical press must become irrelevant to publication of clinical trials.” So said Stephen Senn at a recent meeting of the Medical Journalists’ Association with the title: “Is the current system of publishing clinical trials fit for purpose?” Senn has thrown a few stones in the direction of medical journals in guest posts on this blog, and in this paper, but it’s the first I heard him go this far. He wasn’t the only one answering the conference question “No!” much to the surprise of medical journalist Jane Feinmann, whose article I am excerpting:

 So what happened? Medical journals, the main vehicles for publishing clinical trials today, are after all the ‘gatekeepers of medical evidence’—as they are described in Bad Pharma, Ben Goldacre’s 2012 bestseller. …

… The Alltrials campaign, launched two years ago on the back of Goldacre’s book, has attracted an extraordinary level of support. …

Professor Senn has long argued the AllTrials case, he insisted. ‘There’s no doubt that obtaining a license to market a drug should involve an obligation to share the results with interested parties,’ he said.

His point, however, was that this sharing should not involve medical journals. …There were several reasons, he said, as to why Bad JAMA and other journals were at least as much to blame as Bad Pharma for a lack of transparency in pharmaceutical research: the constant need of the medical press to make a sensational impact, ‘the vanity and ambitions of scientists,’ and the confusing restrictions of embargos—as well as the fact that, despite the evidence, it was clear that journals do favour ‘exciting’ research. Instead of journals, Professor Senn claimed, trials should be self published either on the web or in some publicly searchable registry, such as the website Clinicaltrials.gov.

I wonder if this would have helped in the case of the Potti and Nevins Duke trials. I believe the NCI only discovered it was partially funding one of the trials by noticing it on the clinical trials website.

Between the medical journals and the regulators, Senn puts more trust in the latter.

[A]ccording to Professor Senn, it’s the regulators, virtually alone, that keep medicine safe. ‘Regulators may make mistakes, but they do a better job than the journals,’ he said. ‘Would you want to fly to New York with a big reputable airline like BA, which is heavily regulated? Or a plane built by Professor Smith and his colleagues from the local university?’

What do you think?

With so much to disagree on, speakers and audience members agreed that transparent clinical research is a complex goal, and should be addressed as such. Discussing the future is just the start of the process, pointed out Dr Groves.’Publication bias is not only down to publishers, it is also dependent on people submitting their results including old data, whether it’s in a loft or on a floppy disk or filed away somewhere—so bring out your dead,’ she said. ‘We need to be able to make decisions on all the evidence. That means that observational studies should be regarded as being as important as randomised controlled trials. We know we’ve got to improve and there’s a long way to go. It’s an exciting time,’ she said.

Bring out your dead?

 

Categories: PhilPharma, science communication, Statistics | 5 Comments

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5 thoughts on ““The medical press must become irrelevant to publication of clinical trials.”

  1. Senn is right.
    The Statistical Analysis Plans, and the Clinical Study Reports should be made available in public repositories. Better to upgrade clinicaltrials.gov or EudraCT to be able to host these documents (and hopefully in the future patient level data).

    Christos Argyropoulos
    University of New Mexico

    • Christos: Welcome to the blog. Unlike twitter, you don’t have to write in tiny chunks here.
      I don’t really know what the proposal would be, where would articles of the sort that now go into Nature Medicine appear?

  2. Excellent proposal. The Statistical Analysis Plan and the Clinical Study Reports provide more detail (including safety info) relative to journal articles
    In addition CSRs are structured documents (they follow templates of the ICH) and thus can be abstracted in a machine readable format so as to facilitate evidence synthesis.

    Christos Argyropoulos
    University Of New Mexico

  3. Christos:

    What I think is much more important here is that the Statistical Analysis Plan and the Clinical Study Reports are (with few exceptions) pre-registered, cross-examined and audited (some or even all raw data requested and checked) by full time staff that are paid to find any deficiencies.

    Nothing deep here, just would you like the parachute packed by the (bright, well-motivated but distractible) teaching assistant of a parachuting course or packed by someone who does that for a living that was then double checked and verified by someone else (who was not their friend)?

    What likely might be rather deep here, is that academic clinicians, biostatisticians, systematic reviewers, meta-analysts and other should? become irrelevant and do something else for a career until the issue of access gets resolved. To quote Freud after he commented that a scientific psychology was just not possible in his lifetime “but I have no interest in switching careers”.

    • Keith,

      Pregistration of SAP and the elements that will find their way into the CSR are both good ideas for both industrial and investigator initiated studies (IIS).

      Nevertheless we have to be acknowledge that some safety analyses will always be carried out once the database has been locked, the investigators unblinded and the need to answer such questions becomes apparent.

      Double checking entries and looking for deficiencies is more of a problem for IIS than industrial studies (at least the ones run by entities with solid Quality Management systems). But yeah, not letting the issues in the hands of the TA is a good idea

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