Q: What should I do if the clinical trial has not been registered prospectively?

Detailed Question -

After finishing my manuscript I realized that as per the journal’s guidelines, I needed to attend a registration code for clinical trials before patient recruitment had begun (in 2016 ).The journal has a requirement that authors have to register the clinical trial presented in the manuscript in a public trial registry and include the trial registration number at the end of the abstract. Since I did not register my study before patient recruitment, what should I do now? Should I send a letter to the editor for considering my submitted manuscript or apply for a registration in 2018 and add the number in my manuscript before submission?

1 Answer to this question

Please note that in general, as per the guidelines of Food and Drug Administration Amendments Act (FDAAA 801), a clinical trial needs to be registered within 21 days of enrolment of the first participant. Also, as per the regulation of International Committee of Medical Journal Editors (ICMJE), if an interventional clinical study had not been registered prospectively, the journals that follow ICMJE guidelines would not publish reports of that trial. Therefore, it would be difficult to publish the study without the required registration.

Unfortunately, we shall not be able to provide a solution in this regard, but would recommend contacting the editor of the journal clarifying the situation and also try to contact the relevant authorities. For example: you may contact nimhctobb@mail.nih.gov (if your study is an NIMH funded one) or register@clinicaltrials.gov with your registration related questions

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