What every medical researcher should know about registering 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 Registration of clinical trials is a must, and an unregistered trial will not be published by any journal.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:
- The ICMJE accepts registration in any registry that is a primary register of the WHO International Clinical Trials Registry Platform (ICTRP) or ClinicalTrials.gov, which is a data provider to the WHO ICTRP.
- An acceptable registry must include a minimum 20-item trial registration dataset.
- The registration must be done at or before the time of first patient enrolment.
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.
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