Friday, 16 March 2018

Guest Authors: The alternative view

Earlier this week a piece was published in the Annals of Neurology reporting how certain authors are on clinical trials and implying that they could be "guest authors"; celebrated “key opinion leaders” who do not contribute to trial design or execution, or manuscript drafting, but whose name lends gravitas to the study.

Today Prof A gives a response to this.

First I must say that Prof A is from Canada and is not the "Guest Author A" in the piece by Prof C.

It has been said that I was too critical in the critique so I'll keep my mouth shut but, here is an alternative view

According to Prof A:

"Stated in the editorial is that of 10 individuals considered to fall into this category “all are clinical neurologists; none have particularly rare skill sets”. Although not specifically named, the individuals placed in this category can readily be recognized".

"A review of their overall accomplishments indicates that indeed they do have distinct skillsets that underlie why they have been repeatedly selected for the trials cited"

"Most of the selected individuals are widely recognized for contributions to the MS field that extend far beyond their role in commercial based clinical trials. They have developed large multidiscipline MS centers that have carried out combinations of clinical, imaging, and basic biology based studies that have contributed significantly to our understanding of the MS disease process". 

"Their “non-commercial” contributions can be found in major academic journals and include investigator initiated trials with non-commercial agents. They have been recognized within their own institutions for major leadership roles". 

"They have been repeatedly invited to international congresses and symposia and serve, usually voluntarily, on panels established by governmental and not-for-profit disease agencies that allocate major resources for MS patient care and research".

"Their involvement with multiple studies provides a broad perspective on the MS therapeutic landscape". 

"Further noted is that these individuals are amongst those most frequently selected by the academic journals to referee studies and provide commentaries and reviews. Such selectivity would also apply to the academic basic sciences where key opinion"

"Perhaps we under-appreciate what special skillsets these individuals do have. A review of registered clinical trials that were not successfully completed indicates the importance of selecting key individuals who can deliver"

"As multiple disease directed therapies have come available and as the straight forward placebo-controlled trial has become no longer feasible, it unlikely that that pivotal trials would be successfully executed without clinical experts contributing to trial design or execution". 

" The individuals cited could readily document the time (even if compensated) that they have devoted to the design and reporting of these trials, acknowledging that this done in concert with the sponsor"

"The large clinical trials also include authors who have recruited large patient numbers; the effort and skill involved in running effective MS centers should not be undervalued."

" Subsequent secondary analyses have been reported for most of the approved agents in a range of peer- reviewed journals. Opinions and reviews regarding specific agents are also presented in non- reviewed publications directed at the professional community"

"Concerns in these areas include the involvement of commercial writing companies in compiling and recording the data to be presented." 

"Perhaps writers and presenters should be limited to those who played an active role in the design and oversight of such ongoing trials. A similar critique could be raised for the many more local presentations given by industry selected individuals". 

"Further raised in the [Prof C] editorial is the interests of the clinical trial leaders in promoting MS professional organizations in which they are involved, specifically ECTRIMS and ACTRIMS". 

Prof A is the president of ACTRIMS, an organization that partners with ECTRIMS to hold a joint meeting every 3 years and also has its own annual conference, 

"Although industry influences need to be acknowledged including their on-site presence, these venues have become major go-to sites for dissemination of MS clinical and research findings"

The ACTRIMS board of directors and scientific committee are wholly responsible for the programme.

"Any symposia presented by industry are specifically identified"

"ACTRIMS underwrites the attendance at its annual Forum of trainees from all American and Canadian approved neurology programs, and presents a specific program for them. We aim This article is protected by copyright. All rights reserved. to contribute to development of a new generation of individuals who have expertise to drive clinical investigations and trials, perhaps addressing the issue that the limited number of leaders reflects a failure to train those with such expertise."

"One can readily agree with [Prof C] that we can improve the on the current means of designing and reporting of commercial clinical trials (and the dissemination of subsequent information).... One commends him for drawing to attention the challenges of clinical trial design and data reporting and we both look forward to emergence of a new generation of clinical leaders who will take up these challenges". 
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Antel J.The reality of "ghosts" in authorship of clinical trials in multiple sclerosis. Ann Neurol. 2018 Mar 13. doi: 10.1002/ana.25199. [Epub ahead of print] 
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Do you agree?


20 comments:

  1. Team G, Professor Hawking died this week, as you ought to know.

    I am a wheelchair user with multiple sclerosis. Hawking was the most famous disabled man in the world, famous for transcending his disability. Now he is gone.

    Therefore, what role models as a community do we have? Disabled people have lost a very crucial spokesman and now we have lost a key icon, too.

    Disabled MSers are really fighting in life despite our problems. This blog ought to acknowledge that rather than just presenting us as emblematic of untreated disease. We're unlucky, sure, but we're fighters.

    Thank you for letting me say this.

    ReplyDelete
    Replies
    1. CD20cell: You are so right! Here I have to say that I often wondered how he kept his job through the years... MouseDoctor, correct me if I am wrong ... university professor cannot be removed from the position unless he himself leaves /resigns/moves somewhere else?

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    2. Good comment and believe me you are a big focus of our continuing research, I wish we were further on in addressing treatment for those with more advaced MS.
      As for role models, we're big fans of Wheelchair Kamikaze, who comments here regularly.

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    3. So true. I am also disabled and feel that I'm viewed as a loser because of it by my neurologist. Their focus and appreciation lies with the DMT-worthy MSers.

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    4. " university professor cannot be removed from the position unless he himself leaves /resigns/moves somewhere else?"
      Not these days, there's really no such thing as tenure in Uk academia these days, if the university wants to get rid of you, they will find a way. I'm presuming Prof Hawking's position was emeritus ie retired but still going in as he was well past retirement age. Obviously his fame ensured he would never have been booted out.

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    5. Lucasian professor of mathematics at Cambridge getting booted out.

      "Sorry Mr. Newton but we have decided to let you go":-)

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    6. Our #ThinkHand campaign should tell you our position on this issue.

      Are you an irredeemable?

      http://multiple-sclerosis-research.blogspot.com/2016/11/thinkhand-researchspeak-are-you.html

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    7. As a Professor there is no long-term job security. Although it may take months any Professor can be 'performanced managed' out of their position. Professors are not different to anyone else we have targets (grant income, research expenditure, teaching, publications, impact, and 3rd stream activities). In other words management can easily find a reasons to terminate our employment. Am I at risk? The University can also change its research strategy that makes whole Departments redundant. For example, it may decide to close down neuroscience research and I could then lose my job next month.

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    8. CD20 cell: Neuroscience is the new buzzword, as we live longer and realise that our processing power does not get better with time. So I think Team G folks are safe, there will be more money coming your way :-)

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  2. Yes let's get prof ndg to run some trials. Show some diversity for bame, LGBT and women.

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    Replies
    1. NDG is in line to run several investigator-led trials as PI.

      Delete
  3. In all due respect, as classy as Wheelchair Kamikaze may be, he isn't comparable to Hawking. No-one is, really.

    It is a great loss. So sad. Loved the man, though, never knew him.

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    Replies
    1. WCK is as great as Hawking, it depends on your worldview. For me the WCK trumps Hawking.

      Stephen Hawking was unscrupulous when it came to charging for his voice (I know my wife worked in advertising). I have been told he charged enormous amounts for his electronic voice to be used commercially. I wonder if he bequeathed the commercial rights of his voice to a charity or his family, or the tech company who created it, will retain the rights to his voice?

      Let's face it Stephen Hawking will be immortal. His electronic voice will live on.

      Have you banked your voice?

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    2. Prof G, I find some of your comment a bit strange: Why shouldn't Stephen Hawking have charged those who would profit from using his voice? I hope he did, and then some.

      You don't know much about physics, or was it Hawking's profoundly well informed atheism that rubbed you up the wrong way a bit?

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    3. Why should he not? You charge for your time. I know the expert patients also charge (but keep very quiet- another study for Ben Goldacre)

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    4. Well said, Jimbo. It's pot calling kettle black. Prof G is envious of the great Hawking.

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  4. There is such incredible nuance embedded in this stream of commentary. It is hard, sometimes comma to get ones head around whether the propositions being put forward or to be taken seriously or are simply "straw dogs" been put forward to be knocked over.
    In trying to summarise and have the last word which of course whenever ready can I would say that for an academic in this field one can never really avoid the ever present issue of commercial involvement in drug trial, Are the big companies baddues or not? Some of the myki summer semester we would expect there to be distration Brad's normalised between companies that will really evil companies that we're just sort of so so and companies that were actually working for the best
    My field of specialism is IT and I experience exactly the same in contemplating the big Connorco companies. I have a pretty poor opinion of some of them, veg tolerance events and I'm frankly in love with Google. Somebody else might have an opposing satyr preferences.

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  5. You dont seem to be very concerned about this centralization in the field, are you?

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    Replies
    1. I am deeply concerned as a single centralised view creates a world full of science lemmings. This is OK if the world view is correct, but if it is not. Then it's a problem

      Delete
  6. The following might be of interest:

    How I saw Stephen Hawking's death as a disabled person
    by Ellis Palmer.
    http://www.bbc.co.uk/news/world-43418251

    ReplyDelete

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