Get expert advice to help you get published!

You are here

What every medical researcher should know about registering clinical trials

Kakoli Majumder | Jan 13, 2015 | 39,219 views
Registration of clinical trials

Case: An author sent his paper to us for editing, mentioning that he was planning to submit it to a leading medical journal. The study was based on a clinical trial and his findings were indeed novel. In one of the e-mail exchanges, our editor asked the client whether the clinical trial had been registered, and the author confirmed its registration. The author was satisfied with the editing and was very hopeful that his paper would be accepted by the journal of his choice. He had sent a pre-submission inquiry to the journal, and the Editor-in-chief had shown genuine interest in his work.

However, a few weeks later, we received an e-mail from the author, expressing his disappointment at the paper being rejected after initial screening. The journal editor mentioned that the study did not meet the ICMJE requirements for registration of clinical trials. The author was confused and unhappy with this decision as the trial was already registered. He requested our assistance in finding out why the registration was unacceptable.

Action: On further investigation, we found that the trial had been registered a few weeks after it had started. The ICMJE clinical trial registration policy requires the registration of clinical trials in a public trials registry at or before the time of first patient enrolment as a necessary condition for it to be even considered for publication. In the case of our client, the registration date was much later than the date of enrolment of the first patient. There was no way to solve this problem. We suggested that the author could perhaps try to publish his paper in a journal that was not listed on the ICMJE website, provided he disclosed the issue of late registration upfront in the pre-submission inquiry to his next target journal.

Summary: Authors are not always aware of the clinical trials registration policy followed by the journal. Registration of clinical trials is a must, and an unregistered trial will not be published by any journal.

According to the ICMJE guidelines for registration of clinical trials, any journal that wishes to be listed in the ICMJE website must follow a set of mandates. Here are some of the main requirements:

According to ICMJE, the purpose of registration of clinical trials is to prevent selective publication of research findings and to avoid duplication of research effort. Besides, registration enables patients to know what clinical trials are going on so that they can enrol if they wish to. 

Authors should note that although ClinicalTrials.gov allows trials to be registered at any time during the research (after it has started, after completion of enrolment, or even after completion of the study), the ICMJE strictly requires the registration to be done before or at the time of first patient enrolment.  

You might also be interested in reading the following posts:

Republish

Like this article? Republish it!
Knowledge should be open to all. We encourage our viewers to republish articles, online or in print. Our Creative Commons license allows you to do so for free. We only ask you to follow a few simple guidelines:
  • Attribution: Remember to attribute our authors. They spend a lot of time and effort in creating this content for you.
  • Editage Insights: Include an attribution to Editage Insights as the original source.
  • Consider a teaser: Yes, that’s what we call it…a teaser. You could include a few lines of this post and say “Read the whole article on Editage Insights”. Don’t forget to add the link to the article.
  • Re-using images: Re-publishing some of the images from our articles may need prior permission from or credit to the original image source.
  • Quick and easy embed code: The simplest way to share this article on your webpage would be to embed the code below.

 

Please copy the above code and embed it onto your website to republish.
Download free ebooks, guides and templates.
Editage Insights offers a wealth of free resources on academic research and publishing. Sign up and get complete access to a vibrant global community of 179k researchers.
By clicking 'Join Now', you agree to our Terms & Privacy Policy.
Having trouble registering/logging in? Contact us
Q & A

Have your own question?

Related Categories