Not Registering a Clinical Trial Before Submitting a Manuscript

Recently a post graduate student in our medical school completed a small, randomized clinical trial paid for by small funds from the university, after approval by ethics committee, etc. Unfortunately, she had inadvertently not registered the clinical trial in a recognized database. She has submitted the manuscript to us for consideration for publication. Should we consider it or not? Would value your views please.

James K Tumwine
Editor in Chief, African Health Sciences
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I would like to know if any of you could help me. Have you ever heard about Non-English Databases for EBSCO Publishing (www.epnet.com)? They say they would facilitate inclusion of our publications in one or more of their research databases.

Heliane Campanatti-Ostiz
Executive Editor, Pró-Fono Revista de Atualização Científica
www.revistaprofono.com.br
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I think if there are no signs that the work has been tainted (ie, unduly influenced by pharmas), I would proceed to send it for review. I assume, of course, that this is a drug trial you are talking about. Although the registration requirement, for other reasons, is inclusive, the concerns about pharmas stand out as the main concern. At least that is so in my mind.

IB Pless
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WAME's policy is to "support efforts to register all clinical trials at their inception". http://www.wame.org/resources/policies#trialreg

The ICMJE journals have a tough policy, essentially requiring that trials be registered at or before patient recruitment. They tied themselves in knots a bit, but for any trials beginning after July 2005, the ICMJE journals only allow 'prospective' registration, and for all trials beginning before then, it should be registered before submission to the journal:

"Investigators should register trials that began enrolling patients any time before July 1, 2005 as soon as possible if they wish to submit them to a journal that follows the ICMJE policy. While the ICMJE hoped that all such trials would be registered by September 13, 2005, the committee understands that the policy statement was not entirely clear. Thus, ICMJE journals will consider trials that began before July 1, 2005 that were not registered prior to September 13, 2005. However, beginning on September 13, 2005, ICMJE journals will consider such trials only if they were adequately registered before journal submission. The ICMJE journals will accept "retrospective registration" of trials that began before July 1, 2005 (retrospective meaning registration occurs after patient enrollment begins).

Trials that began after July 1, 2005:

ICMJE journals will consider trials beginning on or after July 1, 2005 only if registration occurred before the first patient was enrolled (“prospective registration”)."

See http://www.icmje.org/clin_trialup.htm, http://www.icmje.org/faq.pdf and their latest statement at http://www.icmje.org/clin_trial07.pdf.

At BioMed Central we require that controlled trials of healthcare interventions be registered in a publicly accessible database (one that is recognised by the ICMJE, see http://www.icmje.org/faq.pdf) before we will proceed with peer review. Thus we allow 'retrospective registration' of trials.

I would suggest that you ask the student (and all authors) to register their trial in a recognised registry before you will send the article for peer review. However, you might wish to adopt the stricter policy of the ICMJE.

In reply to Dr Pless' point about drug company involvement, I think that editors can and should use competing interests as a red flag to watch out for potential problems and biases, but the involvement of drug company money alone could never be enough, in my eyes, to justify not sending the work for peer review. And all trials should be registered, not just those with drug company involvement (but I don't think that was what Dr Pless meant).

Matt Hodgkinson

ps

You should assign a handling editor who is not based at the same university as the author(s), who can select peer reviewers and make the editorial decision. WAME's guidelines state that "Editors assigned the review of a manuscript in which they may have a conflict of interest should recuse themselves from that supervision, and it should be reassigned to an editor with no conflict". http://www.wame.org/resources/publication-ethics-policies-for-medical-journals#conflicts
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No, it was not what I was trying to say; I was trying to say that the issue of registration is of greater importance when the trial is industry sponsored than when it is not. In the latter instance, I think the main rationale for the stiff policy on registration is to ensure that systematic reviews not be biased. Correct me if I am wrong.

But to be clear, I am certainly NOT suggesting for a moment that involvement of drug companies or any other industry is a good reason for not sending for peer review. Once the registration and competing interest issues are clear, peer review is essential for such studies in the hope that any other, more subtle forms of bias, might be detected.

IB Pless