Authorship order in clinical trials?

[geniusindisguise]

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Sorry initially posted in the IM form by mistake. Current fellow here interested in clinical investigation. Curious to know how the authorship order is established for large clinical trials. I have heard that for large multi-center phase III trials, that number of patients enrolled and seniority factor into the authorship. Does that mean that authorship is not pre-established prior to trial activation and is decided at the time of data publication? Do the senior-most authors of the highest enrolling institutions share the first and correspondings for each of the resulting publications? I would imagine that the process depends on variables like industry-sponsored versus cooperative group-based studies, but still would be interested to know some specific examples. I would presume the authorship order for IITs is just up to the PI.

 

[randomhemoncpd]

Oooh - tricky topic. It’s in the companies’ interest to make prospective investigators think that it’s top accruer first and second place last — that’s the incentive to open the trial. Having said that, one of the plum authorship slots is often promised before the trial opens to a steering committee member or another big name in the field.

There is no set answer—key is to get the answer in writing from the company before opening to avoid surprises when you’re the lead accruer yet a middle author.

 

[gutonc]

For most industry sponsored trials, they have already approached a "KOL" or 2 in the disease to be the primary PI, or they have worked with someone in academia to create the trial in the first place. Those folks are getting first/last authorship. My own experience as a middle author on industry trials is that it's either alphabetical, or by enrollment number. I never even bothered to ask since I knew I wouldn't be first or last and the rest are just also-rans.

ETA: As the local PI of a trial, I am the one who will get my name on the paper, regardless of how many people I actually enroll on the study. I've gotten listed on manuscripts where I didn't enroll a single patient, but my partners did, but since I'm the PI, I get the publication credit.

 

[randomhemoncpd]

Not always -- industry trials will sometimes let the lead / second accruing PI's be first/senior. It is important to get the details of authorship in writing beforehand. Middle authorship doesn't really matter - to paraphrase, second authorship is the first loser.

 

[geniusindisguise]

Interesting points. I see there is variability. I presume these ISTs are all being written by industry-paid medical writers so manuscript writing doesn't have any bearing on authorship order as it does with other scientific publications?

 

[gutonc]

Interesting points. I see there is variability. I presume these ISTs are all being written by industry-paid medical writers so manuscript writing doesn't have any bearing on authorship order as it does with other scientific publications?

Pretty much, although to be clear, as a "mid-list author" my only involvement in manuscript writing has been offering edits and signing off on the final version, so I could be wrong about who does most of the writing.

 

[randomhemoncpd]

That’s pretty much right

Pretty much, although to be clear, as a "mid-list author" my only involvement in manuscript writing has been offering edits and signing off on the final version, so I could be wrong about who does most of the writing.

this has been my experience too. They’ll make slides, posters, etc for presentation if you’re first author on a conference abstract too. Manuscript writing on industry trials by and large done their own contracted writers

 

[bobsmith]

These ISTs are all being written by industry-paid medical writers so manuscript writing doesn't have any bearing on authorship order as it does with other scientific publications?

That’s pretty much right

this has been my experience too. They’ll make slides, posters, etc for presentation if you’re first author on a conference abstract too. Manuscript writing on industry trials by and large done their own contracted writers

It's a pretty interesting relationship - I suppose industry sponsors need the support of clinical investigators to enroll patients, get trials and drugs approved, and get general medical acceptance; meanwhile, the investigators (the ones in academia in particular) need the clinical trials, publications, presentations and connections for moving up in the academic ranks. And of course, tons of advances have been made because of this relationship for the benefit of our patients.

That being said, it still always feel a little icky to me when an investigator is giving a talk and very quickly shows a slide for half a second filled with the names of a bunch of companies, says "here are my disclosures," and just moves on. I don't know that it helps me really understand if/how conflicted they might be