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Registering research on a on a public database

Clinical trial registration is the practice of documenting clinical trials before they are performed in a clinical trials registry so as to combat publication bias and selective reporting (Study results are usually required to be uploaded 12 months after the completion of a study).  In addition to combating bias, clinical trial registries serve to increase transparency and access to clinical trials for the public.

The World Medical Association Declaration of Helsinki states that “Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject”

All studies that fall into the following definition of a clinical trial must now be prospectively registered on a publicly accessible database; it is a condition of a favourable ethical opinion to do so and a requirement of Medical Journals when considering articles for publication for publication (as required by International Committee of Medical Journal Editors, ICMJE):

Any research project that prospectively assigns human subjects to intervention and comparison groups to study the cause-and-effect relationship between a medical intervention and a health outcome.

If your research falls into this definition you must make sure you register your study before enrolment of the first patient, otherwise you may not be able to publish.  The recognised registries include:

• ClinicalTrials.gov which accepts the registration of clinical research, including retrospectively.
• International Standard Randomised Controlled Trial Number (ISRCTN) which accepts the registration of randomised controlled trials and any other research study designed to assess the efficacy of health interventions in a human population.  This includes both observational and interventional studies, including retrospective.
• EU Clinical Trials Register which consists of information from the EU Clinical Trial Database, EudraCT.  It accepts interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA) as well as clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.

To register your trial on ClinicalTrials.gov you need to contact the RD&I Office to be given access.  You will not be able be able to access via the main public view page.

Please contact the plh-tr.RD-Office@nhs.net if you have any comments or queries about registering.